Information For Clinicians

The device does not contain any chemicals that release oxygen when it is in use. No dangerous, explosive or harmful gases (e.g. hydrogen) are released. The Oxygen Generator (OG) functions by electrolysing water, held in a polymeric membrane, to oxygen and hydrogen. The oxygen is led by a thin tube to the wound whilst the hydrogen diffuses to a catalyst, close to the membrane, where it reacts with oxygen in the air to generate water. This then flows back to the membrane replacing the water that has been consumed with the overall effect that pure humidified oxygen is separated electrochemically from the nitrogen in air.

The device produces approximately 13 ml/hour of 98% pure oxygen, and in normal ventilated working conditions, there is a very low risk of this becoming a fire hazard.

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Indications for use

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.

 

Device description

The NATROX® system consists of two items; the NATROX® Oxygen Generator and the NATROX® Oxygen Delivery System.

 

NATROX® Oxygen Generator (unit)

The NATROX® unit is used for the duration of the treatment and is a small rechargeable battery powered device worn in a pouch or fitted close to the wound. Moist oxygen is safely generated from the atmosphere and delivered to the wound surface via the ODS. The device is designed to work for the duration of the patient’s treatment.

 

NATROX® Oxygen Delivery System (ODS)

The ODS is a single-use, sterile and oxygen permeable on the wound side ‘web’ like flexible device.

Wound exudate continues to be produced, indeed a sign the healing process has commenced in an otherwise quiescent or dormant wound is a surge of exudate. This must be controlled by standard and established dressings and patient observations. Obviously an excess of exudate if ignored will lead to surrounding wound tissue maceration. Clinicians should monitor dressings for signs of the exudate exceeding the dressing’s absorption capacity or leakage, and change the dressing when accordingly.

 

Instructions for use

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 if considered appropriate. This is especially important in patients who are at risk from skin sensitivity, or where excess exudate production has been observed.

Dressing Application & Connection

Step 1. Remove the sterile ODS dressing from its packaging.

Step 2. Position the ODS centrally on the wound surface white side down and pink side uppermost. We currently only have one dressing size as such wounds larger than 10x10cm should not be treated with Topical Oxygen Therapy.

Step 3. Position the ODS tube to intact skin using a medical grade tape.

Step 4. 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.

Step 6. To start the NATROX® unit slide a charged battery to the unit as shown and see the green indicator flash shortly after the battery is attached, this indicates that the device is working and producing oxygen. Connect the tube to NATROX® 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 CONTINUOUS charge for 24 hours.

PLEASE NOTE: The battery should be replaced with a freshly charged battery every 24 hours. We have supplied two batteries, Green and Blue and a battery charger. 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 Holster is supplied to allow the device to be positioned in various locations 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.

Step 7. The ODS remains on the wound 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. ODS Removal and change of the Dressing.
Upon removal the dressing should be classed as clinical waste and disposed of as per local policy / guidelines.

 

Contraindications

The NATROX® system is contraindicated for the following:

  • Wounds being treated with layers of topical ointments or creams, such as anti-microbial treatments.
  • Inadequately debrided wounds.
  • Deep sinus wounds or tracts.
  • Patients unable to tolerate occlusive/adhesive dressings.
  • Potentially malignant wounds or ulcers.
 

Precautions

The NATROX® system is to be used and fitted by appropriately qualified health care professionals only, and is for single patient use only. The ODS is single use and once removed from the wound it MUST 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 ODS and the ODS kept dry. NATROX® unit may be safely reconnected afterwards. The battery remains in place.

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 ODS 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.

 

Compression bandaging

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.

 

Battery removal

Hold NATROX® unit and placing thumb and finger at the end of the battery, slide it out.

 

Battery charging

Two batteries (Green and Blue) are provided plus a charger for mains 240V AC electricity. A battery must be left on continuous charge at all times. When fully charged NATROX® produces oxygen for around 30 hours. A fully charged battery must be fitted every 24 hours.

As soon as possible connect the charger to a mains supply where it must be left undisturbed. Connect the Green battery to the charger, the yellow light will flash while charging and stays ON when fully charged. Set a routine and change the battery each morning or evening. As batteries are Green and Blue a simple record can be kept on a diary.

Now connect the Blue battery to NATROX® OG and see the small green light flash showing that oxygen is now flowing. Fault Conditions:

  • If the yellow light on the battery does not flash when charging and stays on when fully charged.
  • If the green light on NATROX® OG does not flash when a fully charged battery is fitted.

In both cases: Do not use and report to your Clinician or Inotec AMD, or the distributor. Batteries may be left on charge without concern. A battery should always be on charge ready to use.

 

Pack contents

The NATROX® pack contains:

NATROX® Oxygen Generator
2 x rechargeable batteries (green and blue)
1 x recharging unit
1 x pouch for holding the NATROX® Oxygen Generator
1x Instructions for use
1x Quick Start Guide
1x ODS extension tube

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

Product codes:

ODS: Part No NA058
NATROX® Oxygen Generator unit complete: NAT034
NATROX® Rechargeable Batteries: NAT035
Charging unit: NAT006
Extension tube: NA038
Holster: NA032
Case: NA040
Instructions for use: NA021(UK)
Quick Start Guide: NA059

 

Recycling

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. For the return address please click here.

 

Downloads

Click here to visit our media page to view or download a selection of clinical evidence papers on NATROX®.