Aerogen Solo System Instruction Manual
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Aerogen Solo System Instruction Manual

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Summary of Contents for Aerogen Solo

  • Page 1 System Instruction Manual 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 Nebulisation Modes Functional Test Aerogen Solo Aerosol Flow Rate Calculation Troubleshooting Warranty Life Of Product Specifications Performance Symbols Appendix 1...

  • Page 4: Introduction

    Indications for Use The Aerogen Pro System is a portable medical device for multiple patient use that is intended to aerosolise physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance.
  • Page 5 7. Continuous Nebulization Tube Set* 8. Aerogen Ultra* and I-Guard Aerosol Mask ™ ® * Neonate and paediatric 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

    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.
  • Page 7 • Do not use a syringe with a needle to add medication. • Do not attempt to clean the nebuliser. Use of the Aerogen Solo and T-piece during the administration of volatile anaesthetics may result in adverse effects on the constituent plastics. Do not use with volatile anaesthetics unless known to be compatible.

  • 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 21). Figure 2. Assembly of Aerogen Solo System 1. Connect the Aerogen Solo to the T-piece by pushing the nebuliser 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: Recharging The Battery

    Table 1. Aerogen Pro-X Controls & Indicators Control / Indicator Function • Green (steadily lit) = 30 Minute nebulisation cycle on • Green (flashing) = Low battery 30 Min. Indicator power • Nebuliser automatically powers off after 30 minutes have elapsed •...
  • 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 paediatric breathing circuits connect the nebuliser with the paediatric 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: Optimum Use

    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 8. Optimum Use of the Aerogen Solo Aerogen Solo System Instruction Manual...

  • Page 16: Installation For Use Off-Ventilator

    Patient Reclined Figure 9. Connecting to a mask Use with a Mouthpiece The Aerogen Solo is compatible with any standard ISO 22mm nebuliser mouthpiece inserted into the adult T-piece. When using a mouthpiece, connect the nebuliser to the T-piece and then connect the T-piece to the mouthpiece by pushing the parts firmly together as shown in Figure 10.
  • Page 17 Warning: To ensure correct nebulisation, maintain the nebuliser in a vertical orientation (Figure 9 & Figure 10). 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 nebuliser.
  • Page 18 1. Insert Aerogen Solo nebuliser firmly into Aerogen Ultra in orientation shown in Figure 11. 2. If supplemental oxygen is required, firmly attach oxygen tubing to Aerogen Ultra. Note: Oxygen flow rate should be set between 1-6 LPM. 3. If a face mask is required, remove mouthpiece and attach face mask to Aerogen Ultra.

  • Page 19: Nebulisation Modes

    Nebulisation 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 nebuliser. • The maximum capacity of the nebuliser is 6 mL.
  • Page 20 Tubing (Syringe End) Figure 13. Continuous Nebulization Tube Set 1. Ensure the Aerogen Solo nebuliser 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 21 Aerogen’s recommended input rate of medication into the Aerogen Solo nebuliser during continuous nebulisation 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 nebuliser flow rate. For directions on determining flow rates, refer to the Optional Flow Rate Calculation method in the Functional Test section, page 22.
  • Page 22 • 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 nebuliser is turned off while the feed system is still on or the nebuliser is not in its recommended orientation.

  • Page 23: 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 nebuliser into a circuit or accessory.

  • Page 24: Aerogen Solo Aerosol Flow Rate Calculation

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

  • Page 25: 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 (see flashes during Battery power is low.
  • Page 26 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 authorised personnel: contact your Aerogen sales representative. Aerogen ®...

  • Page 27: Warranty

    Life of Product As with all active electronic components, the Aerogen Solo nebuliser has a defined life. In the case of Aerogen Solo, the life of the nebuliser has been validated for intermittent use for a maximum of 28 days based upon a typical usage profile of 4 treatments per day.

  • Page 28: Specifications

    Specifications Table 3. Physical Specifications of the Aerogen Solo System 67 mm H x 48 mm W x 25 mm D Nebuliser 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 29: Performance

    Performance Table 6. Performance Specifications of the Aerogen Solo Flow Rate > 0.2 mL/min (Average ~ 0.38 mL/min) As measured with the Andersen Cascade Impactor: Specification Range: 1-5 μm Average Tested: 3.1 μm As measured with the Marple 298 Cascade Impactor: Specification Range: 1.5-6.2 μm...

  • Page 30: Symbols

    Symbols Table 7. Aerogen Solo System Symbols Symbol Meaning Symbol Meaning Serial number designation, where Transient storage YY is the year of YYXXXXX temperature limitations manufacture and -20 ºC to +60 ºC XXXXX is the serial number Caution Quantity Attention: Consult...
  • Page 31 Aerogen Solo nebuliser 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 32 • Portable and mobile radio frequency (“RF”) communication devices can disrupt medical electrical equipment. * Consult your local representative for the order number extension specific to your country and for pricing information. Aerogen ®...

  • Page 33: Appendix 1: Emc Tables

    Guidance and manufacturer’s declaration – electromagnetic emissions The Aerogen Solo nebuliser system is intended for use in the electromagnetic environment specified below. The customer or the user of the Aerogen Solo nebuliser system should assure that it is used in such an environment.
  • Page 34 Recommended separation distances between portable and mobile RF communication equipment and the Aerogen Solo nebuliser system that is not life supporting This Aerogen Solo nebuliser system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user...
  • Page 35 Aerogen Solo nebuliser system that is not life supporting This Aerogen Solo nebuliser system is intended for use in the electromagnetic environment specified below. The customer or the user of the Aerogen Solo nebuliser system should assure that it is used in such an environment.
  • Page 36 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Aerogen Solo nebuliser system is used exceeds the applicable RF compliance level above, the Aerogen Solo nebuliser system should be observed to verify normal operation.
  • Page 38 INTL. +353 91 540 400 info@aerogen.com www.aerogen.com twitter.com/aerogen Manufacturer Aerogen Ltd. © 2017 Aerogen Ltd. Part No. AG-AS3050-EN Galway Business Park, P/N 30-354 Rev R Dangan, Galway, Ireland.

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