System Instruction Manual

Contents Introduction 1 Indications for Use System Warnings Assembly & Installation Installation For Use With A Ventilator Installation For Use With Non-Invasive Ventilation Nebulization Modes Functional Test Aerogen Solo Aerosol Flow Rate Calculation Troubleshooting 29 Warranty 31 Life Of Product Specifications 32 Performance 33 Symbols Glossary Aerogen® Solo System Instruction Manual

Introduction 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...

Aerogen Solo System The Aerogen Solo System includes the following components: 1 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* with Mouthpiece and I-Guard™ Aerosol Mask * Pediatric adapters, Continuous Nebulization Tube Set and the Aerogen Ultra are sold separately. Visit www.aerogen.com for full parts list. Aerogen® Solo System Instruction Manual

System 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...

Do not modify this equipment without the authorization of the manufacturer. 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 Aerogen Vibronic® aerosol generator. • Do not use a syringe with a needle to add medication. • Do not attempt to clean the nebulizer. Do not use or store outside of specified environmental conditions. 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...

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 27). 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. 2. Insert the Aerogen Solo and the T-piece into the breathing circuit. Note: For use with other accessories, refer to Figure 12, Figure 13 and Figure 14. 3. Connect the Aerogen Pro-X Controller to the Aerogen Solo using the nebulizer cable. 4. To operate on AC power (the primary mode...

6. 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). Standard Equipment Mount Vertical Universal Mounting Bracket Horizontal...

Aerogen Pro-X Controller On/Off Power • 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

Table 1.  Aerogen Pro-X Controls & Indicators Control / Indicator Continuous Indicator Error Indicator • • • On/Off Power Button • Battery Status Indicator Green (steadily lit) = 30 Minute nebulization cycle on Green (flashing) = Low battery power Nebulizer automatically powers off after 30 minutes have elapsed Green (steadily lit) = Continuous nebulization cycle on Nebulizer does not power off automatically Amber (steadily lit) = Aerogen Solo nebulizer disconnected from Aerogen Pro-X Controller Amber (flashing) = Aerogen Pro-X drive voltage error To operate in 30 Minute Mode, press the On/Off...

Cleaning the Aerogen Pro-X Controller Cleaning of controller and controller cable, AC/DC adapter and mounting brackets: 1. Wipe clean with an alcohol based disinfectant wipe or a quaternary ammonium compound based disinfectant wipe. 2. Check for exposed wiring, damaged connectors, or other defects and replace controller if any are visible. 3. Visually inspect for damage and replace the controller if any damage is observed. Warnings • 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...

Installation for use with a Ventilator T-Pieces - Connection to a Breathing Circuit 1. For 22mm adult breathing circuits connect the nebulizer with adult T-piece into the inspiratory limb of the breathing circuit before the patient Y (Figure 5). Figure 5.  Connecting the Aerogen Solo to an adult breathing circuit 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, as shown for the adult T-piece in Figure 5. The Aerogen Solo can connect to 10mm pediatric breathing circuits with the 15mm...