Aerogen Pro
44Pages

System Instruction Manual

Contents Introduction 2 Indications for Use System Warnings Assembly & Installation Installation For Use With A Ventilator Nebulisation 16 Installation For Use Off-Ventilator Functional Test Cleaning, Disinfection and Sterilisation Troubleshooting 26 Warranty 28 Life Of Product Specifications 29 Performance 30 Symbols 31 Appendix 1 Aerogen® Pro System Instruction Manual

Introduction The Aerogen® Pro System is a portable medical device for multiple patient use that is intended to aerosolise physician-prescribed medications for inhalation that are approved for use with a general purpose nebuliser. This device can be used by patients on and off mechanical ventilation or other positive pressure breathing assistance. Aerogen® Pro is suitable for use by neonate, paediatric to adult patients as described in this manual. It incorporates the Aerogen Vibronic® aerosol generator. Aerogen® Pro is intended for hospital use only. It is designed to operate inline with...

Aerogen Pro System The Aerogen Pro System includes the following components: 1 Figure 1.  Aerogen Pro System 1. Nebuliser with Filler Cap 2. T-Piece (Adult) with Plug 3. Aerogen Pro Controller 4. Controller Cable 5. AC/DC Adapter 6. Universal Mounting Bracket & Equipment Mount Adapter Note:  Visit www.aerogen.com for full parts list. Aerogen® Pro System Instruction Manual

1. The nebuliser holds up to 10 mL of liquid medication. The nebuliser is translucent to allow visual monitoring of medication levels and aerosolisation. When the nebuliser is connected into the breathing circuit, the filler cap can be opened or removed from the nebuliser without causing loss of circuit pressure. Within the nebuliser is the Aerogen Vibronic® aerosol generator, which consists of a domed aperture plate with precision-formed holes that control the size of the aerosol droplets and a vibrational element that creates micro-pumping action to aerosolise medication. Gravity brings...

System Warnings Read and study all instructions before using the Aerogen Pro System and accessories. Only trained medical personnel should operate the device. During use observe for correct functioning of the nebuliser by regularly verifying aerosol is visible and no flashing indicator lights. Do not use a filter or heat-moisture exchanger (HME) between the nebuliser and patient airway. Do not attach a continuous supply of medication to the nebuliser; the device operates in 15 or 30 minute cycles. Clean, sterilise, assemble and perform a functional test (page 19) according to the...

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. Do not immerse or autoclave the controller or AC/DC adapter. Disassemble all parts before autoclaving. Use only with components specified by Aerogen. Do not use or store outside of specified environmental conditions. To avoid mechanical or electrical damage, do not drop the nebuliser or the controller. Do not use in the presence of devices generating high electromagnetic fields such as magnetic resonance imaging (MRI)...

Aerogen Pro Controller On/Off Power • 15 Min. - Press & Release • 30 Min. - Press & hold for 3 Sec. Error Indicator 30 Minute Mode Indicator light 15 Minute Mode Indicator light Battery Status Indicator 9V DC Input Controller Cable Input Figure 2.  Aerogen Pro Controls & Indicators Aerogen® Pro System Instruction Manua

Table 1.  Aerogen Pro Controls & Indicators Control / Indicator Green (steadily lit) = 15 Minute nebulisation cycle on Green (flashing) = Low battery power Nebuliser automatically powers off after 15 minutes have elapsed Green (steadily lit) = 30 Minute nebulisation cycle on Green (flashing) = Low battery power Nebuliser automatically powers off after 30 minutes have elapsed On/Off Power Button Amber = Faulty electrical connection Error Indicator To operate in 15 Minute Mode, press and immediately release the On/Off button To operate in 30 Minute Mode, press and hold the On/Off button for...

Assembly & Installation Aerogen Pro System Set-Up Clean and sterilise the nebuliser and T-piece(s) as described in the Cleaning, Disinfection and Sterilisation section of this manual. Note:  The nebuliser and T-piece, as packaged, are not sterile. 1 Perform a functional test of Aerogen Pro before use and between patients as described in the Functional Test section of this manual (see page 19). 2 Insert the filler cap into the opening on the nebuliser. 3 Connect the nebuliser to the T-piece by pushing the nebuliser firmly onto the T-piece (Figure 3). Figure 3.  Connecting nebuliser to...

Connect the Aerogen Pro controller and the nebuliser together using the controller cable (Figure 4). Figure 4.  Connecting controller and nebuliser 5 To operate on AC power (the primary mode of operation), connect the Aerogen Pro AC/DC adapter to the Aerogen Pro controller and plug the adapter into an AC power source (Figure 5). Figure 5.  Connecting the AC/DC Adapter

The Aerogen Pro 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. Note:  Allow a minimum of four hours for the internal battery to fully recharge. Note:  To ensure uninterrupted operation of the Aerogen Pro, 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...

Installation for use with a Ventilator Connection to a Breathing Circuit 1. For adult breathing circuits, connect the nebuliser with adult T-piece into the inspiratory limb of the breathing circuit before the patient Y (Figure 6). Figure 6.  Connecting the Aerogen Pro to an adult breathing circuit Note:  Figure 6 shows adult configuration only 2. For paediatric breathing circuits, connect the nebuliser with the paediatric T-piece into the inspiratory limb of the breathing circuit before the patient Y (Figure 7). Figure 7.  Connecting to a paediatric breathing circuit