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Summary of Contents for Rhythm Healthcare AURA-NEB PCN843
- Page 1 ITEM# PCN843 AURA-NEB COMPRESSOR NEBULIZER...
- Page 2 Please ensure you have the following components before using your Aura-Neb: Compressor Body Angled Air Tubing Nebulizer Top, Cup Mouthpiece and Pickup Funnel Instruction Manual (5) Air Filters...
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Page 3: Table Of Contents
INDEX IMPORTANT SAFEGUARDS………………………………………………..4-6 Introduction………………………………………………….……………..…..7 Using Your Aura-Neb………………………………………………………….8 Cleaning……………………………………………………………………….12 Changing the Filter and maintenance………………………………………14 Troubleshooting……………………………………………………………….15 Warning and Cautions—Device Symbols………………………………….16 Electromagnetic Compatibility……………………………………………….18 Product Specifications………………………………………………………..26 Warranty……………………………………………………………………….28... -
Page 4: Important Safeguards
IMPORTANT SAFEGUARDS Read and understand all instructions before use. Improper care or use of the nebulizer may result in injury, damage to the unit or ineffective treatment. Following these instructions will ensure the nebulizer’s efficacy and long life. Nebulizer is non-sterile. Clean before use. - Page 5 IMPORTANT SAFEGUARDS WARNING: To reduce the risk of burns, electrocution, fire, or injury to persons: The product should never be left unattended when plugged in. Close supervision is necessary when this product is used by, on, or near children or disabled individuals. Use this product only for its intended use as described in this manual.
- Page 6 IMPORTANT SAFEGUARDS 16. Do NOT operate unit in a backpack or carrying bag. 17. Care should be taken when this product is used near other electronic equipment concerning the possible interference between them. They may need to be moved apart. 18.
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Page 7: Introduction
INTRODUCTION Please read and understand this instruction manual completely before using your unit, to ensure safe and effective use, as well as long life of the product. Statement of Intended Use The aerosol generator is for the production of compressed air to operate a nebulizer for the production of medical aerosol for respiratory disorders. -
Page 8: Using Your Aura-Neb
USING YOUR AURA-NEB NOTE: Before the first use of the nebulizer or if the unit has not been used for an extended period of time, it should be cleaned thoroughly as described in the Cleaning section of this manual. WARNING: Before connecting the power cord, make sure the I/O (ON/OFF) switch is in the O (OFF) position. - Page 9 USING YOUR AURA-NEB The patient receiving treatment should be seated or slightly reclined in a comfortable position as treatments take several minutes. Keep in mind that the nebulizer cup must remain vertical during treatment. 1. Place the compressor unit on a flat, stable surface within operating range of the patient and an electrical outlet.
- Page 10 USING YOUR AURA-NEB 4. Fill and assemble the nebulizer. Step 1: Make sure the pick- up funnel is in place in the bottom half of the nebulizer. 5. Step 2: Pour the medication into the nebulizer cup following the physician prescribed dosage, Fig 2.
- Page 11 USING YOUR AURA-NEB 9. Position the mouthpiece at the patient’s mouth. 10. Turn the power switch to the on (I) position to begin treatment. Inhale deeply and exhale normally. Ensure the nebulizer is vertical during treatment for proper nebulization of the medication and to prevent spilling of the liquid.
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Page 12: Cleaning
CLEANING NEBULIZER CLEANING All parts of the nebulizer (except tubing) should be cleaned according to the following instructions. Your physician and/or drug provider may specify a certain cleaning procedure. If so, follow their recommendations. WARNING: Clean nebulizer after each use. There is a risk of bacteria growth, infection, illness from contamination due to a unsanitary nebulizer. - Page 13 CLEANING COMPRESSOR CLEANING With power switch in the “Off” position, unplug power cord from wall outlet. Wipe outside of the compressor cabinet with a clean damp cloth every few days to keep dust-free. CAUTION: Do NOT use any powdered cleaners or soap pads which may damage the finish.
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Page 14: Changing The Filter And Maintenance
CHANGING THE FILTER AND MAINTENANCE Change the filter every 30 days or when filter turns gray or appears dirty. CAUTION: Never operate the unit without a filter. CAUTION: Do not substitute cotton or any other materials for the filters. CAUTION: Do not attempt to clean the filters or reuse a filter. To replace the filter, follow these steps: Change the filter only when the unit is off, unplugged and completely cool. -
Page 15: Troubleshooting
TROUBLESHOOTING The nebulizer produces no aerosol, or a small amount of aerosol. • There may be too much or too little medicine in the nebulizer. The amount of liquid should be between 2 ml and 8 ml. • The hose connectors may be blocked and need to be cleaned •... -
Page 16: Warning And Cautions-Device Symbols
WARNING AND CAUTIONS—DEVICE SYMBOLS These symbols may appear on your device, instructions or packaging and may vary by make and model. Symbol Meaning Read This Manual—all included manuals should be read prior to first use Warning—symbol indicates a warning, prohibition or mandatory action that mitigates a risk that is not necessarily obvious to the device operator Type BF Applied Parts—indicates that a part of this unit comes in contact with the patient in order to carry out its intended function... - Page 17 WARNING AND CAUTIONS—DEVICE SYMBOLS Symbol Meaning Serial number Alternating current Rx Only: Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.
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Page 18: Electromagnetic Compatibility
ELECTROMAGNETIC COMPATIBILITY Table 1 Guidance and manufacturer’s declaration - electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment -... - Page 19 ELECTROMAGNETIC COMPATIBILITY Table 2 Guidance and manufacturer’s declaration - electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment Immunity Test IEC 60601 Compliance...
- Page 20 ELECTROMAGNETIC COMPATIBILITY Voltage dips, 5% UT 5% UT Main power quality should short (>95% dip in (>95% dip in be that of a typical interruptions and commercial or hospital voltage variations for 0.5 cycle for 0.5 cycle environment. on power supply input lines 40% UT 40% UT...
- Page 21 ELECTROMAGNETIC COMPATIBILITY Table 3 Guidance and manufacturer’s declaration - electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance...
- Page 22 ELECTROMAGNETIC COMPATIBILITY Radiated RF 10V/m 10V/m 80MHz to Where P is the 800MHz： IEC61000-4-3 maximum output power d=1.2 √ �� rating of the transmitter 800MHz to in watts (W) according 2.7GHz： to the transmitter d=2.3 √ �� manufacturer, d is the recommended separation distance in meters (m) Field...
- Page 23 ELECTROMAGNETIC COMPATIBILITY Table 4 Recommended separation distances between portable and mobile RF communications equipment and the [] The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
- Page 24 ELECTROMAGNETIC COMPATIBILITY Table 5 Guidance and manufacturer’s declaration - electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment Radiated RF Test Band...
- Page 25 1970 LTE Band 1, 4, 25; UMTS 2450 2 400 Bluetooth, Pulse – WLAN, modulati 2 570 802.11 on b) b/g/n, 217 Hz RFID 2450, LTE Band 7 5240 5 100 WLAN Pulse – 802.11 modulati 5 800 on b) 5240 217 Hz 5785...
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Page 26: Product Specifications
PRODUCT SPECIFICATIONS Product Name | Description AURA-NEB | COMPRESSOR NEBULIZER Model Number PCN843 Sound Level average 52dBA +\-5 dB(A) Compressor Pressure >25 psi (172Kpa) Compressor Flow Rate >9 L / minute Temperature: 50ºF – 104ºF (10ºC – 40ºC); 10%-95% RH Operating Conditions Temperature: -13ºF –... - Page 27 Particle size characterization with Cascade Impactor *: Features Drug Result Albuterol Sulfate (2.5 mg/3 ml) 2.57±0.42 Particle Size (MMAD) (μm) Ipratropium Bromide (0.5 mg/2.5 ml) 2.43±0.29 Cromolyn Sodium (20 mg/2.0 ml) 1.93±0.15 Geometric Albuterol Sulfate (2.5 mg/3 ml) 3.52±0.04 Standard Ipratropium Bromide (0.5 mg/2.5 ml) 3.46±0.29 Deviation...
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Page 28: Warranty
3-YEAR LIMITED WARRANTY Your compressor is warranted to be free from defects in material, and workmanship for a period of 3 years from the date of purchase. The warranty covers only the compressor. The replaceable components like nebulizer, mouthpiece, air hose, and filters are not included. Opening or altering the device invalidates the warranty. - Page 29 Rhythm Healthcare, LLC 3200 Tyrone Blvd N St. Petersburg, FL 33710 Email: contactus rhythmhc.com Website: www.rhythmhc.com V1: 09/07/22...
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