Aura Medical PORTANEB NB40 Operation Manual
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Aura Medical PORTANEB NB40 Operation Manual

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AURA
PORTANEB
OPERATION MANUAL

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Summary of Contents for Aura Medical PORTANEB NB40

  • Page 1 AURA PORTANEB OPERATION MANUAL...
  • Page 2 READ THIS MANUAL COMPLETELY AND CAREFULLY BEFORE USING THIS PRODUCT Keep this manual for future reference INDICATION FOR USE The Mesh Nebulizer model NB40 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult patients and pediatric patients at the discretion of their physican at home, hospital &sub-acute care setting.

  • Page 3: Signs And Symbols

    SIGNS AND SYMBOLS The following signs and symbols appear in this manual. Read and understand this entire manual completely and carefully before using this product. Follow all safety instructions and warnings to avoid hazardous situation. DANGER indicates a hazardous situation which, if not avoided, will result in death or serious injury.
  • Page 4 • Before use, ensure that there is no visible damage to the unit or accessories. Never operate the unit if it: • has any damaged parts, e.g. damaged cord, plug or housing • has been exposed to extreme humidity or to any liquids inside the housing •...
  • Page 5 • Do not operate the unit in the presence of flammable gases, oxygen andaerosol spray products. Non-compliance may result in e.g. fire, burns, explosions, etc. • Single patient use only: For hygienic reasons, each user must use his own accessories to avoid the risk of infections and communication of diseases. •...

  • Page 6: Table Of Contents

    • If the medicine tank is empty, do not attempt to operate the unit. CONTENTS 1. Important safety notes 2. Getting acquainted 3. Important information on the device 4. Description of device and accessories 5. Initial use 6. Operation 7. Cleaning 8.

  • Page 7: Important Information On The Device

    AREA OF APPLICATION The Aura Portable Nebulizer is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by both adult and pediatric patients and is suitable for use at home.

  • Page 8: Description Of Device And Accessories

    3.3 SHUTTING THE DEVICE OFF AFTER USE • When the medication cup is empty please shut off the device to avoid damaging the mesh or internal elements. DESCRIPTION OF DEVICE AND ACCESSORIES OVERVIEW OF NEBULIZER 1. Nebulizer main unit 2. Medicine tank 3.

  • Page 9: Initial Use

    Initial Use • Packaging materials are a deadly hazard for children and can cause suffocation. Remove all packaging materials immediately and keep them away from children at all times. • To reduce the risk of increased bacterial growth, infection, illness, injury from contamination or other health risks, always follow all hygiene instructions, see Section 7 Cleaning, when using this unit.
  • Page 10 Note: To remove the medicine tank from nebulizer main unit, press the button (Refer to Fig.2) and pull upward. Button Fig. 2 5.2 OPERATING THE DEVICE WITH BATTERIES/ INSERTING BATTERIES: • Swallowing batteries and/or battery fluid can be extremely dangerous. Keep the batteries and unit out of the reach of children and disabled persons.
  • Page 11 Never use different types of batteries, battery brands or batteries with • different capacities. Always replace all batteries at the same time. • Leaking batteries may damage the device. If you do not intend to use the • unit for a long period of time, remove the batteries from the battery compartment before placing the device in storage.
  • Page 12 Do not use any AC Adapter other than the one supplied with the unit. • When using the AC Adapter, take precaution of all warnings and safety • information in order to avoid hazardous situations. Never touch the unit, including the AC Adapter with wet hands while it is •...

  • Page 13: Operation

    Note: • Ensure that there is a socket near to where the device will be used. Use the mains cable in a way that no one can trip over it. • To disconnect the nebulizer from the mains after use, first switch off the device and then remove the AC adaptor from the socket •...
  • Page 14 • Do not use medicine with viscosity higher than 3 in this device. Mesh transducer module warranty excludes damage due to incorrect or inappropriate medicine viscosity used. • Apart from the prescribed medication, use only distilled water or a saline solution with the unit.
  • Page 15 6.2 Filling the nebulizer a. Open the medicine tank by lifting the hook. (Refer to Fig.5, 6) b. Fill the medication into the medicine tank. (Refer to Fig. 7) c. Close the medicine tank by pressing the hook firmly and securely back to place.
  • Page 16 Fig. 9 6.4 Inhalation with the mask a. Connect mask connector to the medicine tank opening, then connect mask to the mask connector. (Refer to Fig. 10, 11) b. Sit upright and hold the device as upright as possible, do not tilt the device more than 45 degrees in any direction.

  • Page 17: Cleaning

    Note: You can collect the residue of medicine inside mask tube and put it back to medicine tank to vaporize again. (Refer to Fig.12) Fig. 12 CLEANING • Before you clean the unit, always switch it off, unplug it and let it cool off. •...
  • Page 18 (hand washing, handling of medicines or inhalation solutions) in high-risk groups (e.g. cystic fibrosis patients), contact your physician. • When cleaning, ensure that all residues are removed. Never use any substances that may be poisonous upon contact with the skin or mucous membranes, or when swallowed or inhaled.
  • Page 19 4. Turn on the device and allow the solution to nebulize for 2 minutes. 5. Discard the vinegar solution. Add 4 cc’s of water and nebulize for 2 minutes. 6. Power off the device and discard remaining water. 7. Allow to air dry completely for 4-6 or overnight. Cleaning the accessories: 1.

  • Page 20: Storage And Care For The Device

    Note: This cleaning procedure has been done and tested. The test conducted 30 treatments and cleaning cycles. Each treatment and cleaning cycle consisted of placing an albuterol sample into the Portable Nebulizer, nebulizing it to the end. After nebulizing, cleaning and drying the mesh transducer module, medicine tank and accessories according to cleaning/ drying instructions mentioned above.

  • Page 21: Disposal

    uniton the floor. • Do not leave medication inside the medicine container when not in use. • Never open or attempt to repair the unit yourself. Failure to observe this shall void the warranty. • Store the device and accessories in a location protected against environmental influences, i.e.
  • Page 22 than 3). The medicine should be specified by the doctor. The batteries are almost flat. Please change batteries. There may be air bubbles inside the medicine tank which are preventing the medicine from coming in contact with the mesh. Please check and remove bubbles.
  • Page 23 RE-START INSTALLATION INSTRUCTIONS FOR NB40 MESH TRANSDUCER MODULE Whenever you are to use a new mesh transducer module, a “mesh transducer module re-start installation” process should be performed. a. Put 2 ml. of water into the medicine tank. b. Press and hold Power On/ Off button for about 10 seconds. You will see an orange light flash 2 times, once on the 5 second and once on the 10 second.

  • Page 24: Fcc Statement

    FCC STATEMENT This device complies with Part15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation” Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.

  • Page 25: Technical Specifications

    TECHNICAL SPECIFICATIONS Dimensions (L xWx H ) 52.5 x 52 x 126 mm Device weight 110 g excluding batteries Battery operation 2 x 1.5 V type AA Alkaline battery (LR6) Medicine tank capacity 2 ml to 10 ml Atomization rate approx 0.25 ml/min Oscillation frequency 100 kHz...
  • Page 26 PERFORMANCE SUMMARY DATA Albuterol Sulfate Ipratropium Bromide Cromolyn Sodium (2.5 mg/3.0 ml) (0.5 mg/2.5 ml) (20 mg/2.0 ml) Table shows a summary of the measured performance data that indicates confidence intervals corresponding to a 95% confidence level for all combined data. Protocol 13-0028 PIPER MEDICAL PROTOCOL: I n tra-Sample and Inter-Sample Dose and Particle Size Variability Testing of...
  • Page 27 ELECTROMAGNETIC COMPATIBILITY • The device complies with current specifications with regard to electromagnetic compatibility and is suitable for use in all premises, including those designated for private residential purposes. The radio frequency emissions of the device are extremely low and in all probability. •...
  • Page 28 Guidance and manufacturer’s declaration – electromagnetic immunity The NB40 is intended for use in the electromagnetic environment specified below. The customer or the user of the NB40 should assure that it is used in such an environment. Immunity test IEC 60601 Compliance Electromagnetic test level...
  • Page 29 Guidance and manufacturer’s declaration – electromagnetic immunity The NB40 is intended for use in the electromagnetic environment specified below. The customer or the user of the NB40 should assure that it is used in such. Immunity test IEC 60601 Compliance Electromagnetic test level level...
  • Page 30 Recommended separation distances between portable and mobile RF communications equipment and the NB40 The NB40 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the NB40 help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the NB40 as recommended below, according to the maximum output power of the communications equipment.

  • Page 31: Warranty And Service

    WARRANTY AND SERVICE The Portable Nebulizer includes a 3-year warranty covering the product material and manufacturing defects. The warranty does not cover: • Damage resulting from incorrect operation and mishandling. • Wearable parts (e.g. mesh transducer module, masks, mask connector, mouthpiece) •...
  • Page 32 Manufactured For: Aura Medical LLC Brooklyn, NY 11205 For support please contact us at: Phone: 516-253-1063 Email: support@aura-medical.com Web: www.aura-medical.com...

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