Aerogen Solo Instruction Manual
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Aerogen Solo Instruction Manual

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Diane crist
April 24, 2025

How many intermittent uses can you get from a solo?

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1 comments:
Mr. Anderson
May 12, 2025

The Aerogen Solo can be used for 28 days of intermittent use.

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Summary of Contents for Aerogen Solo

  • Page 1 System Instruction Manual www.aerogen.com www.aerogen.com...

  • Page 3: Table Of Contents

    Indications for Use System Warnings Assembly & Installation Installation For Use With A Ventilator Optimum Use Installation For Use Off-Ventilator Nebulization Modes Functional Test Aerogen Solo Aerosol Flow Rate Calculation Troubleshooting Warranty Life Of Product Specifications Performance Symbols Glossary Appendix 1...

  • Page 4: Introduction

    (29 days or older) and adult patients as described in this manual. Indications for Use The Aerogen Solo Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance.
  • Page 5 6. Universal Mounting Bracket & Equipment Mount Adapter 7. Continuous Nebulization Tube Set* 8. Aerogen Ultra* and I-Guard Aerosol Mask ® ™ * Pediatric adapters, Continuous Nebulization Tube Set and Aerogen Ultra are sold separately. Visit www.aerogen.com for full parts list. Aerogen Solo System Instruction Manual ®...

  • Page 6: System Warnings

    Use only with Aerogen Solo components, connectors and any accessories, which are specified by Aerogen in this instruction manual. Do not use beyond defined life (see page 16 for Aerogen Ultra and page 27 for Aerogen Solo System). Do not use in the presence of flammable substances or flammable anesthetic mixtures combined with air, oxygen or nitrous oxide.
  • Page 7 Federal (US) Law restricts this device to sale by or on the order of a physician. Use of the Aerogen Solo and T-piece during the administration of volatile anesthetics may result in adverse effects on the constituent plastics. Do not use with volatile anesthetics unless known to be compatible. Aerogen...

  • Page 8: Assembly & Installation

    Assembly & Installation Aerogen Solo System Set-Up Perform a functional test of the Aerogen Solo before use as described in the Functional Test section of this manual (See page 23). Figure 2. Assembly of Aerogen Solo System 1. Connect the Aerogen 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 Aerogen Solo System from the mains power supply. • The continuous mode can only be operated from AC power supply.
  • Page 10 • 30 Min. - Press & Release • Continuous Mode - 3 Sec. hold from off Error Indicator 30 Minute Mode Indicator light Continuous Mode Indicator light Battery Status Indicator 9V DC Input Controller Cable Input Figure 4. Aerogen Pro-X Controls & Indicators Aerogen ®...
  • Page 11 Table 1. Aerogen Pro-X Controls & Indicators Control / Indicator Function • Green (steadily lit) = 30 Minute nebulization cycle on 30 Min. Indicator • Green (flashing) = Low battery power • Nebulizer automatically powers off after 30 minutes have elapsed • Green (steadily lit) = Continuous nebulization cycle on Continuous Indicator •...
  • Page 12 • Do not immerse or autoclave the Aerogen Pro-X Controller, cable or AC/DC adapter. • Do not place the Aerogen Pro-X Controller in an incubator during use. • Do not use abrasive or sharp tools. • Do not spray liquid directly onto the controller.

  • Page 13: Installation For Use With A Ventilator

    T-piece into the inspiratory limb of the breathing circuit before the patient Y (Figure 5). Figure 5. Connecting the Aerogen Solo to a breathing circuit Note: Figure 5 shows adult configuration only 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.
  • Page 14 2. The Aerogen Solo can be placed on the dry side of the humidifier as shown in Figure 7. The Aerogen Solo can be used with a nasal interface in this configuration. Figure 7. Aerogen Solo on dry side of humidifier 3.
  • Page 15 T-piece and HME volumes is suitable for the tidal volume being delivered. See Table 3 for T-piece volumes. Figure 9. The Aerogen Solo placed between the HME and endotracheal tube. 5. Follow ventilator manufacturer instructions for performing a leak test after inserting or removing the nebulizer.

  • Page 16: Optimum Use

    Otherwise the function of the expiratory channel may be degraded. Optimum Use For optimum use of the Aerogen Solo, ensure it is correctly orientated as shown in Figure 8. This applies to both 30 Minute and Continuous modes. Figure 10. Optimum Use of the Aerogen Solo Aerogen ®...

  • Page 17: Installation For Use Off-Ventilator

    Patient Reclined Figure 11. Connecting to a mask Use with a Mouthpiece The Aerogen Solo is compatible with any standard ISO 22mm 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 12.
  • Page 18 Warning: To ensure correct nebulization, maintain the nebulizer in a vertical orientation (Figure 11 & Figure 12). Use with a Nasal Interface The Aerogen Solo can be used on/off ventilator with a nasal interface when configured with a humidifier (Figure 7). Aerogen Ultra The Aerogen Ultra is an accessory specific to the Aerogen Solo nebulizer.
  • Page 19 The Aerogen Ultra is a single patient use device with a validated defined life of: • In intermittent use for a maximum of 20 treatments; which is based upon a typical usage profile of four 3 mL doses per day over 5 days, with an average treatment time of 9 minutes.
  • Page 20 • Do not exceed recommended oxygen flow for system. • Ensure oxygen connection port or tubing is not occluded. • Do not use the Aerogen Ultra without a mouthpiece or face mask. • Visually check Aerogen Ultra post-rinsing to ensure that valves have not become dislodged.

  • Page 21: Nebulization Modes

    Nebulization Modes 30 Minute Mode (Intermittent) Warnings • To avoid damage to the Aerogen Solo, do not use a syringe with a needle. • During use observe for correct functioning of the nebulizer. • The maximum capacity of the nebulizer is 6 mL.
  • Page 22 Tubing (Syringe End) Figure 15. Continuous Nebulization Tube Set 1. Ensure the Aerogen Solo nebulizer is firmly fitted into the Aerogen Solo T-piece in the breathing circuit. 2. Remove the syringe cap from the medication-filled syringe. 3. Attach the syringe end of the tubing onto the syringe.
  • Page 23 Aerogen’s recommended input rate of medication into the Aerogen Solo nebulizer during continuous nebulization is up to a maximum of 12 mL per hour. The upper limit of 12 mL per hour is based on Aerogen’s specification for the minimum nebulizer flow rate. For directions on determining flow rates, refer to the Optional Flow Rate Calculation method in the Functional Test section, page 24.
  • Page 24 • Ensure that the tubing is safely orientated to prevent a trip hazard. • Rising level of medication in the reservoir may occur if the Aerogen Solo nebulizer is turned off while the feed system is still on or the nebulizer is not in its recommended orientation.

  • Page 25: Functional Test

    Functional Test Perform a functional test of the Aerogen 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 nebulizer into a circuit or accessory.

  • Page 26: Aerogen Solo Aerosol Flow Rate Calculation

    Calculation (Optional) Flow rates may vary between individual Aerogen Solo nebulizers. The minimum flow rate for all Aerogen Solo nebulizers is 0.2 mL per minute. In order to calculate the flow rate of an individual Aerogen Solo nebulizer, follow these steps: 1.

  • Page 27: Troubleshooting

    Troubleshooting If these suggestions do not correct the problem, discontinue use of any device and contact your local Aerogen sales representative. Table 2. Aerogen Pro-X Controller Troubleshooting If this happens: It could mean: Try this: The 30 Min. indicator Recharge battery flashes during Battery power is low.
  • Page 28 It may mean that it is time Contact your local Aerogen Flashing amber light. to replace controller. sales representative. Note: The rechargeable battery in the Aerogen Pro-X Controller should only be replaced by Aerogen authorized personnel: contact your Aerogen sales representative. Aerogen ®...

  • Page 29: Warranty

    As with all active electronic components, the Aerogen Solo nebulizer has a defined life. In the case of Aerogen 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 30: Specifications

    Specifications Table 3. Physical Specifications of the Aerogen Solo System 67 mm H x 48 mm W x 25 mm D Nebulizer Dimensions 2.6” H x 1.88” W x 1.1” D Aerogen Pro-X Controller 33mm H x 75mm W x 131mm D Dimensions 1.3”...

  • Page 31: Performance

    Table 7 shows the results of aerosol performance testing for the Aerogen 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 32 1.85 - 4.19 2.36 - 4.51 (% of fill) Table 8 shows the Inhaled Dose (%) for the Aerogen Solo Nebulizer and Aerogen Ultra with supplemental gas flow, measured on a breathing simulator. Table 8. Inhaled Dose (%) for the Aerogen Solo and Aerogen Ultra...

  • Page 33: Symbols Glossary

    Symbols Glossary Table 9. Aerogen Solo System Symbols Symbol Meaning Symbol Meaning Serial number designation, where Transient storage YY is the year of temperature limitations YYXXXXX manufacture and -20 ºC to +60 ºC XXXXX is the serial number Caution Quantity Attention: Consult...
  • Page 34 Aerogen Solo nebulizer system. • Do not use the Aerogen 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.

  • Page 35: Appendix 1: Emc Tables

    Guidance and manufacturer’s declaration – electromagnetic emissions The Aerogen Solo nebulizer system is intended for use in the electromagnetic environment specified below. The customer or the user of the Aerogen Solo nebulizer system should assure that it is used in such an environment.
  • Page 36 Recommended separation distances between portable and mobile RF communication equipment and the Aerogen Solo nebulizer system that is not life supporting This Aerogen Solo nebulizer system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user...
  • Page 37 Aerogen Solo nebulizer system that is not life supporting This Aerogen Solo nebulizer system is intended for use in the electromagnetic environment specified below. The customer or the user of the Aerogen Solo nebulizer system should assure that it is used in such an environment.
  • Page 38 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Aerogen Solo nebulizer system is used exceeds the applicable RF compliance level above, the Aerogen Solo nebulizer system should be observed to verify normal operation.
  • Page 40 (886) 423-7643 info@aerogen.com www.aerogen.com twitter.com/aerogen Manufacturer Aerogen Ltd. © 2017 Aerogen Ltd. Part No. AG-AS3050-US Galway Business Park, P/N 30-674 Rev H Dangan, Galway, Ireland.

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