Proper and careful cleaning of Nox Recorders and accessories is essential for hygiene and safely maintaining the equipment. Cleaning the Nox equipment involves two main steps. The first is to remove any organic matter before performing the second step, disinfection of the device and cables. Please follow the steps outlined below and carefully choose suitable cleaning agents. Avoid spraying on the equipment, and ensure it is not left wet.

Materials/equipment required:

• Endozime® AW Plus or Laboratoires Anios™ Aniosurf ND Premium or equivalent validated hospital cleaner.
• PDI Sani-Cloth Plus Germicidal Disposable Cloth or equivalent validated hospital-grade disinfectant if they are safe to use on gold plating, metals, and plastics*.
• Lint-free cloths.
• Gloves.
• Soft bristle nylon brush (i.e., electrode brush, toothbrush, or nail brush).

Nox A1/A1s and Nox T3/T3s Recorder Cleaning and Disinfection:

Cleaning of Nox A1/A1s and Nox T3/T3s Recorder:

The goal of the cleaning process is to remove any organic matter or material that will reduce the effectiveness of the disinfection process.

1. Prepare a solution of Endozime® AW Plus or Laboratoires Anios™ Aniosurf ND Premium or equivalent validated hospital cleaner.
2. Follow the instructions accompanying the hospital-grade cleaner - for Endozime® AW Plus, 1mL in 250mL warm water.
3. Dampen a lint-free cloth with the solution. Ring the cloth so it is damp and not dripping wet to avoid any liquids entering any openings on the Nox Recorder.
4. Wipe the surface of the recorder thoroughly to remove all visible organic matter and contaminants. Wipe the device and components for at least 2 minutes. Use a soft bristle nylon brush if necessary.
5. Visually inspect the cleaned components to ensure all organic matter has been removed. Pay good attention to all junctions and details. Repeat steps 3 and 4 if necessary.
6. Allow components to air dry completely before disinfection (minimum of 3 minutes)

Note:

• Do not pour or spray any liquids onto the device, nor allow any liquids to enter openings. The recorders are not waterproof and could be damaged by direct contact with liquid. **
• Do not immerse the Nox recorder clip straps in liquid***
• Avoid contact of the cleaning solution with cable/electrode connectors. Wipe them off with clean water and dry them immediately if this occurs. This will prevent the oxidation of the metal pins in the connectors.

Disinfection of Nox A1/A1s and Nox T3/T3s Recorder:

1. After removing the organic matter, disinfect the device by wiping it with a PDI Sani-Cloth Plus Germicidal Disposable Cloth or equivalent validated disinfectant*.
2. Wipe all surface areas of the recorder with the disinfectant for at least 3 minutes.
3. Allow components to air dry completely before next use (minimum 1 minute)
4. Inspect the components under adequate lighting conditions (and magnification if needed) to confirm that the cleaning/disinfection process has not damaged components. Inspect for surface wear, discolouration, corrosion, or cracking**.

Cleaning Nox Nox A1 EEG 5 Lead Electrode Cable:

1. Soak the electrodes in warm water (55–65°C/131–149°F) for a minimum of 5 minutes to soften the dried electrode paste. Note that electrode paste can take a while to dissolve; warm water will aid in this process.
2. Allow the Gold Cup Electrodes to air dry thoroughly (minimum 3 minutes)
3. Wipe the electrodes with a Super Sani-Cloth Plus Disinfection Wipe or equivalent validated disinfectant*.
   • Do not excessively rub but gently wipe the gold portion of the electrodes.
   • Do not disinfect the electrodes with bleach.
   • If other disinfection wipes are used, make sure:
   • They are safe to use on gold plating, metals, and plastics.
   • Read the instructions from the manufacturer regarding the required contact time of the solution to provide sufficient disinfection.
4. Allow the Gold Cup Electrodes to air dry completely (minimum 1 minute)
5. Inspect the Gold Cup Electrodes under good lighting conditions (and magnification if needed) to confirm that the cleaning/disinfection process has not damaged components. Inspect for surface wear, discoloration, corrosion, or cracking.**.

• Note: Never soak or wipe with detergent on the USB connector of the cable, as this can damage or corrode the connector. Note: Do not soak the electrodes in alcohol or bleach. Please do not use an abrasive-based cleaner on the electrodes, as it can damage the gold plating. Use a lint-free cloth, a soft bristle brush or a Q-tip to remove all traces of electrode paste from the electrodes. Only apply light force when cleaning gold-plated surfaces. Gold plating is soft and can easily be damaged or scratched, increasing the impedance of the electrode.

Cleaning Nox Abdomen Cable, Nox Snap on Cables, and Carry Cases.

1. Prepare a solution of Endozime® AW Plus or Laboratoires Anios™ Aniosurf ND Premium or equivalent validated hospital cleaner.
2. Dampen a lint-free cloth with the solution. Ring the cloth so it is damp and not dripping wet, as you want to avoid any liquids entering the connectors.
3. Wipe all surface areas of the component with the disinfectant for at least 2 minutes. Allow to air dry for 3 minutes.
4. To disinfect, wipe for 3 minutes with a Super Sani-Cloth Plus Disinfection Wipe or equivalent validated disinfectant*.
   • For the Nox Abdomen Cable and Snap-On electrodes, do not wet the connectors, and use a tissue to dry and remove moisture if these areas get wet during the cleaning process. This is particularly important for the Nox Abdomen Connector in the image below. 
5. Allow to air dry before reuse.

Cleaning and Disinfecting the Nonin WristOx2® 3150 and 3150BLE and associated accessories

Regarding cleaning/disinfection and re-use of 3rd party components and 3rd party sensors refer to the applicable 3rd party accompanying instructions.

Nonin WristOx2® 3150 and 3150BLE Device Cleaning Procedure:

These cleaning instructions are adapted from the Nonin Operator’s Manual.

1. Wipe the device with a soft cloth dampened with a 10% bleach/90% water solution (household bleach containing less than 10% sodium hypochlorite).
2. Do not use undiluted bleach or any cleaning solution other than those recommended here, as permanent damage could result.
3. Dry with a soft cloth or allow to air dry. CAUTION: Do not place the WristOx2, Model 3150, in liquid or clean it with agents containing ammonium chloride or isopropyl alcohol

Cleaning the Nonin WristOx2 Soft Sensor

These cleaning instructions are adapted from Nonin’s Operator Manual.

1. Unplug the sensor from the pulse oximeter before cleaning.
2. To clean the sensor, wipe all patient contact surfaces with a soft cloth dampened with a mild detergent or a 10% bleach/90% water solution (household bleach containing less than 10% sodium hypochlorite).
3. Allow the sensor to dry thoroughly before using. Note:
   • To minimize cable deterioration when cleaning the cable, gently wipe away from the plug end towards the sensor end.
   • Do not sterilize in an autoclave or immerse/soak the sensor in a liquid of any kind.
   • Do not pour or spray any liquids onto the sensor. Do not use caustic or abrasive cleaning agents on the sensor.
   • Do not use cleaning agents containing ammonium chloride. The use of these chemicals may shorten the life of the product.

Cleaning Nonin WristOx2 Wrist Band

Warning: The Nonin wristband is for single-patient use only. The wristband may be cleaned; refer to 3rd party instructions for use accompanying the pulse oximeter for cleaning instructions, but after cleaning, the wristband should only be applied to the same patient, not to a different patient.

Other Nox Accessories

• The Nox disposable RIP belts are single-use ONLY.
• The Nox nasal cannulas and filter tube connectors are single-use ONLY.
• Follow local governing ordinances and recycling instructions regarding the disposal or recycling of this device and accessories, including batteries.

Note:

• In compliance with the European Directive on Waste of Electrical and Electronic Equipment (WEEE) 2002/96/EC, do not dispose of this product as unsorted municipal waste. For proper treatment, recovery and recycling, please dispose this product to designated municipal recycling center where it will be accepted free of charge.
• Disposing of this product correctly will help save valuable resources and prevent any potential negative effects on human health and the environment, which could otherwise arise from inappropriate waste handling.
• Note: Please contact your distributor regarding take-back or recycling of the components.

Appendix

* PDI Sani-Cloth Plus Germicidal Disposable Cloth is an Environmental Protection Agency (EPA) registered product for the disinfection of medical devices in the United States of America. For Europe or Rest of the World equivalent validated disinfectants may be used if they are safe to use on gold plating, metals, and plastics. Similar disinfection wipes from PDI are available in Europe and are recommended to use with the Nox Sleep System: Super Sani-Cloth Plus disinfection wipes.

** If any component damage occurs during the cleaning process, contact Nox Medical immediately at support@noxmedical.com. Do not attempt to use the Nox Sleep System until the device has been inspected and repaired by authorized Nox Medical personnel.

*** If necessary, the clips on the Nox A1 and T3 recorders can be removed before cleaning. The cleaning process described above also applies to the clips. If the clips are visibly contaminated, they should be replaced

REV3 - LBL-0409