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Sunset Healthcare NEB400 Instruction Manual

Mini mesh nebulizer
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Instruction Manual
Mini Mesh Nebulizer
NEB400
Rx only

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Summary of Contents for Sunset Healthcare NEB400

  • Page 1 Instruction Manual Mini Mesh Nebulizer NEB400 Rx only...

  • Page 2: Table Of Contents

    Table of Contents 1. Before Using the Device 1.1 Introduction and Warranty ..................1 1.2 Contents of the Mini Mesh Nebulizer Package ............2 1.3 Intended Use ......................3 1.4 Safety Precautions ....................4 1.5 Classification and Explanation of Symbols ............6 1.6 Components......................7 2. Correct Use of the Unit 2.1 Operating with Batteries or USB Cord ..............9 2.2 How to Insert or Replace the Batteries ...............11 2.3 How to Connect the Power Adapter to Nebulizer ..........13...

  • Page 3: Before Using The Device

    ONE YEAR LIMITED WARRANTY Sunset Healthcare Solutions offers a limited 1-year warranty on the Mini Mesh Nebulizer unit to be free from defects in material and workmanship under normal use and operation for a period of 1 year from date of original retail purchase.

  • Page 4: Contents Of The Mini Mesh Nebulizer Package

    Replace any damaged parts before use. In the case of missing parts, malfunction, or damage, please contact your local dealer/place of purchase. 1. Main unit 2. Medication cup 3. USB cord NEB400-CUP Instruction Manual Mini Mesh Nebulizer NEB400 4. Instruction manual 5. Bag 6.

  • Page 5: Intended Use

    **Please replace parts in the following situations: • After using the main unit for 2 years. • After using the medication cup for 1 year. Medication cup should be inspected after each cleaning for physical damage, cracks or leaks. If medicine cup is not in good condition after inspection or takes longer than 10 minutes to deliver 2mL of mediction, it should be replaced.

  • Page 6: Safety Precautions

    1.4 Safety Precautions To ensure safe and effective use of the nebulizer, please read the instruction manual carefully before using. WARNINGS • The nebulizer is intended for aerosolizing respiratory medication and only doctor’s prescribed medication can be used. The manufacturer cannot be held liable for any damage caused by improper or incorrect use.
  • Page 7 CAUTIONS • Clean the nebulizer before first use, after each use and after extended storage to avoid unwanted contamination. • Clean and disinfect the mesh in accordance with the user manual to avoid possible damage. • Operational temperature should be kept within 10 ~ 40°C / 50 ~ 104°F to avoid damaging the device.

  • Page 8: Classification And Explanation Of Symbols

    1.5 Classification and Explanation of Symbols Symbols Meaning Caution or Warning, consult accompanying documents BF type is a degree of protection against electrical shock (applied part). Protects against solid foreign objects that are >12.5 mm in diameter and drops of water falling at up to 15° from the vertical.

  • Page 9: Components

    1.6 Components Medication Cup 1. Medication cup cap To be opened when filling the medication or cleaning the cup. 2. Cup Prescribed nebulizer medication can be filled here by opening the cap (8 ml/cc). 3. Mouthpiece To be placed between teeth with lips firmly sealed around it, and to facilitate inhalation of aerosolized medication.
  • Page 10 Main Unit Bottom side 10-12 ON/OFF button 8. Electrodes Press Release Button to remove the Connects the main unit with medication cup. the nebulizing mesh on medication cup. 9. Inner latch Medication cup is securely installed onto the main unit before nebulization. 10.

  • Page 11: Correct Use Of The Unit

    2. Correct Use of the Unit 2.1 Using the Nebulizer with Batteries or USB Cord Battery Power Step 1. Check the parts (Refer to Chapter 1.2) Step 2. Clean and disinfect the medication cup when using the nebulizer for the first time (Refer to Chapter 3) Step 3.
  • Page 12 USB Power Step 1. Check the parts (Refer to Chapter 1.2) Step 2. Clean and disinfect the medication cup when using the nebulizer for the first time (Refer to Chapter 3) Step 3. Assemble the main unit and medication cup (Refer to Chapter 2.4) Step 4.

  • Page 13: How To Insert Or Replace The Batteries

    2.2 How to Insert or Replace the Batteries Before assembling the unit and filling the medication cup. Inserting Batteries 1. Turn the unit upside down. 2. Remove the battery cover by sliding in the direction of the arrow. 3. Insert batteries (not included) according to the battery polarity shown inside.
  • Page 14 • Battery life depends on capacity and condition of the batteries. • In general, device can operate approximately 4 days with new batteries, based on a usage of a 20-minute daily treatment, or 90 continuous minutes. Warning Batteries must be removed if the unit is not in use for extended period. Failure to do so may result in damage due to battery leak.

  • Page 15: How To Connect The Power Adapter To Nebulizer

    2.3 How to Connect Power Adapter to Nebulizer When Using USB (After filling the cup with medication) Remove batteries before using nebulizer with USB cord. 1. Insert the large USB cable end into a USB power source. 2. Remove USB power socket cover on the bottom of the main unit and insert the small USB cable end into the USB socket.

  • Page 16: How To Assemble The Unit And Fill The Medication Cup

    2.4 How to Assemble the Unit and Fill the Medication Cup Caution • When using the device for the first time, or after daily use, or after not using it for an extended period of time, clean and disinfect the medication cup. Refer to Chapter 3.1 for instructions. •...
  • Page 17 1. Assemble the medication cup: Assemble the device by firmly attaching the medication cup to the main unit, making sure the three locks are aligned with the inner latches. Align three locks. Correct Misaligned 2. Open the medication cup cover.
  • Page 18 3. Fill in the prescribed medication as illustrated. The maximum capacity is 8 ml/cc. DO NOT EXCEED THE LIMIT. (Max. 8ml/cc). 4.Carefully replace the cover until it is firmly sealed with a “click” sound. 5.The device is now ready for use. Refer to the next page for instructions on how to select nebulization mode and inhale with the nebulizer.

  • Page 19: How To Select The Nebulization Mode

    2.5 How to Select the Nebulization Mode • By quickly pressing the ON/OFF button once ( ), the device will nebulize continuously for 30 minutes prior to automatic stopping. • If the ON/OFF button is pressed again during nebulization, the nebulizer will turn off.
  • Page 20 Caution In some positions (e.g. tilting backward), nebulization may stop after a while. Re-adjust to upright position in order to re-immerse the nebulizing mesh with medication. Tilting Backward 2. Gently position the mouthpiece between teeth with lips firmly sealed around it. Be calm and relaxed when inhaling and exhaling through mouth.

  • Page 21: Correct Cleaning And Disinfection Procedure

    3. Correct Cleaning and Disinfection Procedure 3.1 How to Clean the Unit after Each Use Warning • Without correct and frequent cleaning and disinfection, micro-organisms may build up in the unit and cause potential infection. • Medication cup should be cleaned after each use. Caution •...
  • Page 22 Warning • Do NOT rinse or immerse the main unit into any kind of liquid. • Make sure the electrodes are dried. • Do NOT poke the mesh with finger, cotton swab or any objects. 8. Make sure that all cleaned parts are completely dried before installation. 9.

  • Page 23: How To Disinfect The Unit

    3.2 How to Disinfect the Unit Caution Without correct and frequent cleaning and disinfection, micro- organisms may build up in the unit and cause potential infection. When to disinfect the unit The medication cup, mesh and mouthpiece should be disinfected: - Before using the device for the first time - After the unit has not been used for more than a week - Twice a week during normal use...

  • Page 24: Troubleshooting

    4. Troubleshooting 4.1 Troubleshooting Problem Possible Causes Corrective Actions Replace with new batteries. Batteries are low. (Please see Chapter 2.2) Clean mesh by immersing in hot The holes on the mesh are boiled water. stained or clogged. Slow (Please see Chapter 3.2) nebulization The mesh is broken.
  • Page 25 Problem Possible Causes Corrective Actions Re-install the medication cup on The medication cup is incorrectly main unit. installed. (Please see Chapter2.4) Clean medicine cup by immersing The holes on the mesh are in hot boiled water. stained or clogged. (Please see Chapter3.2) The mesh is broken.

  • Page 26: Technical Data

    4.2 Technical Data Product Mini Mesh Nebulizer Model NEB400 Working Active Vibrating Mesh Technology Technology Vibrating Approx. 117kHz±15% Frequency AA Alkaline battery × 2 Power Source USB 5V 1A Power < 1.5 W Consumption Nebulization Rate >0.25 ml/min Particle Size...
  • Page 27 Capacity of Approx. 8 ml Medication Cup Dimension Approx. L78 X W41 X H73 mm Weight Approx. 74g (Excluding batteries) Operation Temperature 10~40°C/50-104°F, 30-85% RH and Humidity 800hPa - 1060hPa Range Storage and Delivery -20-70°C/-68-158°F, 20-75% RH Temperature and 800hPa - 1060hPa Humidity Range Ingress Protection IP22...
  • Page 28 The following specifications were established via performance tests using an eight-stage cascade impactor at a flow rate of 28 L/min equipped with a USP <601> induction port throat. Three (3) device samples were tested with 3 runs each, for a total of 9 sample points per each drug for a total of 27 data points. Aerosol was sampled directly from the outlet.
  • Page 29 Proposed Mini Mesh Nebulizer Features Drugs @ 12 L/ @ 28 L/min Albuterol 279-726 913-1214 Coarse Particle Dose Ipratropium 85-138 213-291 (>4.7 micron)Albuterol Cromolyn Sodium 3723-4676 7240-10277 Albuterol 1290-1506 1026-1597 Fine Particle Dose Ipratropium 241-286 212-218 (<4.7 micron) Cromolyn Sodium 8995-10307 8135-10507 Albuterol...

  • Page 30: Electromagnetic Compatibility Data

    Guidance and manufacturer’s declaration of electromagnetic immunity The NEB400 will continue to operate normally throughout the immunity testing below. The customer or the user of the NEB400 should assure that it is used in such an environment.
  • Page 31 Immunity IEC 60601-1- Compliance Guidance Test 2 Test Level Level Electro-Static ±6 kV contact ±8 kV contact The relative humidity should be at Discharge least 5 % ±8 kV air ±5 kV air (IEC 61000-4-2) Electrical fast ±2 kV power ±2 kV power Mains power quality should be that transient/burst...
  • Page 32 Guidance and manufacturer’s declaration - of NEB400. Guidance and manufacturer’s declaration-electromagnetic emissions The NEB400 is intended for use in the electromagnetic environment specified below. The customer or the user of the NEB400 should assure that it is used in such an environment. Electromagnetic Emission test...
  • Page 33 RF communications equipment and the NEB400 The NEB400 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the NEB400 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the NEB400 as recommended below, according to the maximum output power of the communications equipment.
  • Page 34 Electromagnetic Compatibility Data This equipment is intended for use in the electromagnetic environment specified below. The user should ensure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic environment-guidance test test level level Portable and mobile RF communications equipment should be used no closer to any part of the unit, including cables, than the recommended separation distance calculated from the equation...
  • Page 35 WEEE (Directive on Wasted Electrical and Electronic Equipment) This marking shown on the product indicates that it should not be disposed of, with other household wastes, at the end of its working life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate this from other types of wastes and recycle it responsibly to promote the sustainable reuse of material resources.
  • Page 36 Manufactured for Sunset Healthcare Solutions 180 N Michigan Ave Ste 2000 Chicago, IL 60601 NEB400-IFU V1.00 www.sunsethcs.com 2019-01-16...

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