The Aerogen® Solo nebulizer is for single patient use only and the Aerogen® Pro-X Controller is for re-use. The Aerogen Solo System is suitable for intermittent

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1Contents Introduction 2Indications for Use 2System Warnings 4Assembly & Installation 6Installation For Use With A Ventilator 11 Optimum Use 14 Installation For Use Off-Ventilator 15 Nebulization Modes 19 Functional Test 23 Aerogen Solo Aerosol Flow Rate Calculation 24 Troubleshooting 25 Warranty 27 Life Of Product 27 Speci˜cations 28 Performance 29 Symbols Glossary 31 Appendix 1 32 Appendix 1: EMC Tables 33

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2Introduction The Aerogen ® Solo System is an iteration of the Aerogen ® Pro Nebulizer System. The indications for use of the Aerogen ® Solo Nebulizer System are given below. The Aerogen ® Solo System consists of the Aerogen ® Solo nebulizer and the Aerogen ® 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 Aerogen ® Solo nebulizer is for single patient use only and the Aerogen ® Pro-X Controller is for re-use. The Aerogen Solo System is suitable for intermittent and continuous nebulization of pediatric (29 days or older) and adult patients as described in this manual. Indications for UseThe 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.

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3Aerogen Solo System The Aerogen Solo System includes the following components: Figure 1. Aerogen Solo System 1. Aerogen Solo With Plug 2. T-Piece (Adult)* 3. Aerogen Pro-X Controller 4. Controller Cable 5. AC/DC Adapter 6. Universal Mounting Bracket & Equipment Mount Adapter 7. Continuous Nebulization Tube Set* 8. Aerogen ® Ultra* * Pediatric adapters, Continuous Nebulization Tube Set and Aerogen Ultra are sold separately. Visit for full parts list. 12345678

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4System Warnings Read and study all instructions before using the Aerogen Solo System and accessories. Only trained medical personnel should operate the device. This is a single patient use device not to be used on more than one patient to prevent cross infection. The components and accessories of the Aerogen Solo System, as packaged, are not sterile. The components and accessories of the Aerogen Solo System are not made with natural rubber latex. Inspect all parts before use, and do not use if any parts are missing, cracked or damaged. In case of missing parts, malfunction or damage, contact your sales representative. Only use physician-prescribed solutions that are approved for use with a general purpose nebulizer. Consult drug manufacturer™s instructions regarding suitability for nebulization. Use only with Aerogen Solo components, connectors and accessories speci˜ed by Aerogen in this instruction manual. Do not use beyond de˜ned life (see page 16 for Aerogen Ultra and page 27 for Aerogen Solo System). Do not use in the presence of ˚ammable substances or ˚ammable anesthetic mixtures combined with air, oxygen or nitrous oxide. To avoid the risk of ˜re, do not use to aerosolize alcohol-based medications, which can ignite in oxygen-enriched air under high pressure. Do not autoclave any component or accessory of the Aerogen Solo System.

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6Assembly & 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 ˜rmly onto the T-piece. 2. Insert the Aerogen Solo and the T-piece into the breathing circuit. Note: For use with other accessories, refer to Figure 11, Figure 12 and Figure 13. 3. Connect the Aerogen Pro-X Controller to the Aerogen Solo using the nebulizer cable. 4. To operate on AC power (the primary mode of operation), connect the Aerogen Pro-X AC/DC adapter to the Aerogen Pro-X Controller. 5. Plug the adapter into an AC power source.

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76. The Aerogen Pro-X Controller can be battery-operated for portable applications. The rechargeable battery can power the System for up to 45 minutes when fully charged. In the case of AC power failure the controller will automatically switch to battery operation. 7. Use the universal mounting bracket to attach the controller to an IV pole or bed rail in either a vertical or horizontal orientation (Figure 3). 8. Where a standard equipment mount is available, use the equipment mount adapter to support the controller (Figure 3). Figure 3. Aerogen Pro-X Controller and universal mounting bracket con˜gurations Warnings To ensure uninterrupted operation of the Aerogen Solo, secure both the AC/DC adapter cable and the controller cable so they cannot become disconnected during treatment. If clips are available on patient circuits, run the cables through the eyes of the clips. 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. Do not over-tighten knob on the universal mounting bracket. Vertical Universal Mounting BracketHorizontalUniversal Mounting BracketEquipmentMount AdapterStandard Equipment Mount

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9Table 1. Aerogen Pro-X Controls & Indicators Control / Indicator Function 30 Min. Indicator Green (steadily lit) = 30 Minute nebulization cycle on 30 minutes have elapsed Continuous Indicator Green (steadily lit) = Continuous nebulization cycle on automatically Error Indicator Amber (steadily lit) = Aerogen Solo nebulizer disconnected from Aerogen Pro-X Controller Amber (˜ashing) = Aerogen Pro-X drive voltage error To operate in 30 Minute Mode, press the On/Off button once To operate in Continuous Mode, press and hold the On/Off button for greater than 3 seconds from off Pressing during nebulization turns off Indicator 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. Allow a minimum of four hours for the internal battery to fully recharge.

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