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Summary of Contents for Aerogen Aeroneb Solo
- Page 1 Aeroneb Solo System Instruction Manual ®...
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Page 3: Table Of Contents
Solo System Instruction Manual ® Introduction System Warnings Assembly & Installation Installation For Use With A Ventilator Installation For Use Off-Ventilator Nebulization Modes Aeroneb Solo Aerosol Flow Rate Calculation Troubleshooting Parts List Warranty Life Of Product Specifications Performance Symbols Appendix 1... -
Page 4: Introduction
Pro-X controller. It is intended for hospital use only to nebulize physician- ® prescribed medications for inhalation which are approved for use with a general purpose nebulizer. The Aeroneb Solo nebulizer is for single patient use only and the Aeroneb Pro-X controller is for re-use. - Page 5 5. AC/DC Adapter 6. Universal Mounting Bracket & Equipment Mount Adapter 7. Continuous Nebulization Tube Set* 8. Aeroneb Solo Adapter* * Pediatric adapters, continuous nebulization tube set and Aeroneb Solo Adapter are sold separately. Aeroneb Solo System Instruction Manual ®...
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Page 6: System Warnings
Use only with Aeroneb Solo components, connectors and accessories specified by Aerogen in this manual. Do not use beyond defined life (see page 13 for Aeroneb Solo Adapter and page 24 for Aeroneb Solo System). To avoid the risk of fire, do not use in the presence of flammable substances or flammable anaesthetic mixtures combined with air, oxygen or nitrous oxide. - Page 7 To avoid damage to the nebulizer: • Do not apply undue pressure to the domed aperture plate in the center of the nebulizer. • Do not push out the vibrating mesh aerosol generator. • Do not use a syringe with a needle to add medication. •...
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Page 8: Assembly & Installation
Assembly & Installation Aeroneb Solo System Set-Up Perform a functional test of the Aeroneb Solo before use as described in the Functional Test section of this manual (See page 18). Figure 2. Assembly of Aeroneb Solo System 1. Connect the Aeroneb Solo to the T-piece by pushing the nebulizer firmly onto the T-piece. - Page 9 If clips are not available, ensure that all cables are routed safely. • The AC/DC adapter is the means of isolating the Aeroneb Solo system from the mains power supply. • The continuous mode can only be operated from AC power supply.
- Page 10 • Green (steadily lit) = Continuous nebulization cycle on Continuous Indicator • Nebulizer does not power off automatically • Amber (steadily lit) = Aeroneb Solo nebulizer disconnected from Fault Indicator Aeroneb Pro-X controller • Amber (flashing) = Aeroneb Pro-X drive voltage error • To operate in 30 minute mode press the On/Off button once...
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Page 11: Recharging The Battery
Recharging the Battery To recharge the battery, connect the AC/DC adapter to the controller and connect to AC power source. The battery status indicator is amber while charging and green when fully charged. If the controller is placed in long-term storage, it is recommended that the battery be recharged every 3 months. -
Page 12: Installation For Use With A Ventilator
For 15mm pediatric breathing circuits connect the nebulizer with the pediatric T-piece into the inspiratory limb of the breathing circuit before the patient Y. The Aeroneb Solo can connect to 10mm pediatric breathing circuits with the 15mm pediatric T-piece and the pediatric adapters. This can be positioned approximately 30 cm (12 in.) back from the patient Y (Figure 6). - Page 13 2. The Aeroneb Solo can be placed on the dry side of the humidifier as shown in Figure 7. The Aeroneb Solo can be used with a nasal interface in this configuration. Figure 7. Aeroneb Solo on dry side of humidifier 3.
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Page 14: Installation For Use Off-Ventilator
Figure 8. Connecting to a mask Use with a Mouthpiece The Aeroneb Solo is compatible with any standard ISO 22 mm nebulizer mouthpiece inserted into the adult T-piece. When using a mouthpiece, connect the nebulizer to the T-piece and then connect the T-piece to the mouthpiece by pushing the parts firmly together as shown in Figure 9. - Page 15 Note: The mouthpiece should not be used for children under 5 years of age. The Aeroneb Solo Adapter is a single patient use device with a validated defined life • In intermittent use for a maximum of 20 treatments; which is based upon a typical usage profile of four 3ml doses per day over 5 days, with an average treatment time of 9 minutes.
- Page 16 A facemask is not provided. Inspect for device integrity and correct valve placement prior to use. 1. Insert Aeroneb Solo nebulizer firmly into Adapter in orientation shown in Figure 10. 2. If supplemental oxygen is required, firmly attach oxygen tubing to Adapter.
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Page 17: Nebulization Modes
Nebulization Modes Intermittent Mode Warnings • To avoid damage to the Aeroneb Solo, do not use a syringe with needle. • During use observe for correct functioning of the nebulizer. • The maximum capacity of the nebulizer is 6 mL. - Page 18 4. Prime the tubing until the medication reaches end of tubing (Point A). Note: The tubing priming volume is maximum 3.65 mL. 5. Unplug the tethered cap from the Aeroneb Solo nebulizer, but do not remove it from the nebulizer.
- Page 19 • The level of the medication in the reservoir of the Aeroneb Solo nebulizer should be periodically monitored to ensure that the fill rate of medication does not exceed the output rate of the nebulizer.
- Page 20 Functional Test Perform a functional test of the Aeroneb Solo System prior to first use or at any time to verify proper operation. This test is to be carried out prior to inserting the neb into a circuit or accessory.
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Page 21: Aeroneb Solo Aerosol Flow Rate Calculation
Aeroneb Solo Aerosol Flow Rate Calculation Flow rates may vary between individual Aeroneb Solo nebulizers. The minimum flow rate for all Aeroneb Solo nebulizers is 0.2 mL per minute. In order to calculate the flow rate of an individual Aeroneb Solo nebulizer: 1. -
Page 22: Troubleshooting
Troubleshooting If these suggestions do not correct the problem, discontinue use of any device that appears to be damaged or is not operating properly and contact your local Aerogen product sales representative. Table 2. Aeroneb Pro-X Troubleshooting If this happens:... - Page 23 Contact your local Aerogen Flashing amber light. replace controller. Product sales representative. Note: The rechargeable battery in the Aeroneb Pro-X controller should only be replaced by Aerogen authorized personnel: contact your Aerogen product sales representative. Aeroneb Solo System Instruction Manual ®...
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Page 24: Parts List
• Aeroneb Pro-X Controller • Universal Mounting Bracket • AC/DC Adapter • Instruction Manual Aeroneb Solo Convenience Kit - Pack of 5 AG-AS3300-US • Aeroneb Solo nebulizers • Adult T-pieces with silicone plugs Aeroneb Solo Convenience Kit - Pack of 10 AG-AS3350-US • Aeroneb Solo nebulizers... - Page 25 AG-AP1085 Universal Mounting Bracket AG-AP1060 Equipment Mount Adapter AG-AP1070 Aeroneb Solo Starter Kit Instruction Manual AG-AS3050-US Aeroneb Solo Adapter Starter Kit – Pack of 10 AG-AS7500-US Aeroneb Solo Adapter – Pack of 10 AG-AS7000-US Aeroneb Solo System Instruction Manual ®...
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Page 26: Warranty
As with all active electronic components, the Aeroneb Solo nebulizer has a defined life. In the case of Aeroneb Solo, the life of the nebulizer has been validated for intermittent use for a maximum of 28 days based upon a typical usage profile of 4 treatments per day. -
Page 27: Specifications
FRIWO (AG-AP1040-US) AC/DC adapter (input 100 to 240 VAC 50 – 60 Hz, output 9 V) or internal rechargeable battery (4.8 V nominal output). Power Source Note: The Aeroneb Pro-X controller is approved for use with Aerogen AC/ DC adapter AG-AP1040-US (Manufacturer Reference: FRIWO FW7660/09) Power Consumption <... -
Page 28: Performance
The temperature of the medication will not rise more than 10°C (18°F) above ambient during normal use. Table 8 shows the results of aerosol performance testing for the Aeroneb Solo using an 8 stage cascade impactor running at a continuous flow rate of 28.3 LPM. Indicated ranges correspond to confidence intervals with a confidence level of 95%. - Page 29 41.6 – 34.7 48.4 – 39.5 Results are Inhaled Dose %, expressed as a % of the Nominal Dose placed in the Aeroneb Solo Nebulizer, across a range of supplemental gas flows. The results provided are the maximum and minimum values for 3 devices tested at each flow rate with each interface.
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Page 30: Symbols
Symbols Table 10. Aeroneb Solo System Symbols Symbol Meaning Symbol Meaning Serial number designation, where Transient storage temperature YY is the year of manufacture and YYXXXXX limitations –20 °C to +60 °C XXXXX is the serial number Quantity Attention, consult accompanying... - Page 31 Instruction Manual may result in increased emissions or decreased immunity of the Aeroneb Solo nebulizer system. • Do not use the Aeroneb Solo adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in this configuration.
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Page 32: Appendix 1: Emc Tables
Guidance and manufacturer’s declaration – electromagnetic emissions The Aeroneb Solo nebulizer system is intended for use in the electromagnetic environment specified below. The customer or the user of the Aeroneb Solo nebulizer system should assure that it is used in such an environment. - Page 33 Guidance and manufacturer’s declaration – electromagnetic immunity This Aeroneb Solo nebulizer system is intended for use in the electromagnetic environment specified below. The customer or the user of the Aeroneb Solo nebulizer system should assure that it is used in such an environment.
- Page 34 This Aeroneb Solo nebulizer system is intended for use in the electromagnetic environment specified below. The customer or the user of the Aeroneb Solo nebulizer system should assure that it is used in such an environment.
- Page 36 © 2014 Aerogen Ltd. Part No. AG-AS3050-US P/N 30-674 Rev D Manufacturer Aerogen Ltd. Galway Business Park, Dangan, Galway, Ireland PHONE INTL. +353 91 540 400 www.aerogen.com U.S. +1-886-423-7643...
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