System Instruction Manual
40 Pages
Preview
Page 1
System Instruction Manual
www.aerogen.com
Contents Introduction
2
Indications for Use
2
System Warnings
4
Assembly & Installation
6
Installation 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
Specifications
28
Performance
29
Symbols Glossary
31
Appendix 1
32
Appendix 1: EMC Tables
33
Aerogen® Solo System Instruction Manual
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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 nebulization of pediatric (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.
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Aerogen Solo System The Aerogen Solo System includes the following components: 1
2
5
6
3
4
7
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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 www.aerogen.com for full parts list.
Aerogen® Solo System Instruction Manual
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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 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 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. To avoid the risk of fire, 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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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 in adverse effects on the constituent plastics. Do not use with volatile anesthetics unless known to be compatible. Aerogen have determined that, using anesthetic ventilators, the following volatile anesthetic agents are compatible under the stated conditions below: Anesthetic Agent
Proprietary Name
Maximum Percentage of Anesthetic
Maximum Duration of Exposure
Isoflurane
FORANE®
3.5 %
12 hours
Sevoflurane
SEVOFLURANE®
8%
12 hours
Desflurane
SUPRANE®
10 %
12 hours
Aerogen® Solo System Instruction Manual
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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. 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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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 Universal Mounting Bracket
Equipment Mount Adapter
Figure 3. Aerogen Pro-X Controller and universal mounting bracket configurations
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.
Aerogen® Solo System Instruction Manual
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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
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Table 1. Aerogen Pro-X Controls & Indicators Control / Indicator
Function •
30 Min. 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 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 power to the nebulizer Green = Battery fully charged Amber = Battery charging No light = Battery in operation
Recharging the Battery 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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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 use abrasive or sharp tools. •• Do not spray liquid directly onto the controller. •• Do not wrap the nebulizer cable tightly around any of the system components. •• Do not use in the presence of devices generating high electromagnetic fields such as magnetic resonance imaging (MRI) equipment. •• The Aerogen Pro-X Controller contains a nickel metal hydride (NiMH) rechargeable battery, which should be disposed of in accordance with local governing regulations at the end of its useful life. •• Follow local laws and recycling plans regarding disposal or recycling of components, batteries and packaging.
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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 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. The Aerogen Solo can connect to 10mm pediatric breathing circuits with the 15mm pediatric T-piece and the pediatric adapters. This can be positioned approximately 30cm (12 in.) back from the patient Y (Figure 6).
Figure 6. Connecting to a pediatric breathing circuit Aerogen® Solo System Instruction Manual
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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. The Aerogen Solo can be placed between the wye and endotracheal tube as shown in Figure 8. The Aerogen Solo can be used with a Heat and Moisture Exchange Device (HME) which may contain a filter.
Figure 8. The Aerogen Solo placed between the wye and endotracheal tube.
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4. Only a HME approved for use with a nebulizer should be used in this configuration (Figure 9). Follow the HME manufacturer instructions regarding use with a nebulizer. Ensure the combination of nebulizer, 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. Warnings •
•
Only use with HME devices whose manufacturer’s instructions allow use with a nebulizer, and always follow the HME manufacturer’s instructions. Ensure that the total combined volume of nebulizer, T-piece and HME is suitable for the tidal volume being delivered and does not increase dead space to the extent that it adversely impacts the ventilatory parameters of the patient. Aerogen® Solo System Instruction Manual
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• • • •
Always monitor the resistance to flow and excessive rain-out and change the HME device as per manufacturer’s instructions. Do not use a filter or heat-moisture exchanger (HME) between the nebulizer and patient airway. Condensate can collect and occlude ventilator circuits. Always position ventilator circuits so that fluid condensate drains away from the patient. Always connect a bacteria filter to the expiratory inlet of the ventilator. 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
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Installation for use Off-Ventilator Use with a Face Mask Mask kits, which include a vented elbow and mask elbow, are available separately (visit www.aerogen.com for full parts list). 1. When using a mask, connect the vented elbow, mask elbow and mask to the nebulizer by firmly pushing the parts together. 2. Rotate the vented elbow to suit the position of the patient (Figure 11).
FaceFace MaskMask Elbow Elbow
Vented Vented Elbow Elbow Patient Patient Upright Upright
Patient Patient Reclined 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.
Figure 12. Connecting to a mouthpiece Aerogen® Solo System Instruction Manual
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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. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to pediatric (29 days or older) and adult patients in hospital use environments via mouthpiece or aerosol face mask. If supplemental oxygen is used, for pediatric patients under 18 years of age, a maximum flow rate of 2 LPM should be used. Note: The mouthpiece should not be used for children under 5 years of age.
Mouthpiece Face Mask
Aerogen Ultra Aerogen Solo
Oxygen Tubing
Figure 13. Assembly of Aerogen Ultra
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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. or •• In continuous use, for a maximum of 3 hours. The Aerogen Ultra can be used in conjunction with the Aerogen Solo Continuous Nebulization Tube Set (see page 20). Optimal aerosol delivery is achieved with valved mouthpiece or valved face mask with low/no oxygen flow. A face mask is not provided. Inspect for device integrity and correct valve placement prior to use. 1. Insert Aerogen Solo nebulizer 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 for adult and a maximum of 2 LPM for pediatric patients less than 18 years of age. 3. If an aerosol face mask is required, remove mouthpiece and attach the aerosol face mask to Aerogen Ultra. Note: When using an aerosol face mask, a minimum oxygen flow of 1 LPM is required. 4. Add medication to nebulizer. 5. Connect cable to Aerogen Solo and power on controller. 6. Introduce Aerogen Ultra to patient and observe aerosol flow to ensure correct operation. 7. Remove excess rainout from the Aerogen Ultra periodically (hourly with continuous nebulization). 8. To ensure optimum performance of the Aerogen Ultra, remove any residue by rinsing through with sterile water, shake off excess and allow to air dry.
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Warnings •• Do not use with a closed face mask or a standard oxygen mask. •• When using with an aerosol face mask, always use supplemental oxygen flow of 1-6 LPM for adult and a maximum of 2 LPM for pediatric patients less than 18 years of age. •• Performance of the Aerogen Ultra may vary depending upon the type of drug and Aerogen Ultra configuration used. •• 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. •• Do not cover Aerogen Ultra valves during use. •• Do not use Aerogen Ultra in conjunction with the Aerogen Pro nebulizer. •• Do not autoclave any component of the kit. •• Ensure tubing is safely orientated to prevent strangulation hazard.
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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.
For intermittent doses less than or equal to 6 mL: 1. Open the plug on the nebulizer. 2. Use a pre-filled ampoule or syringe to add medication into the filler port of the nebulizer (Figure 14). 3. Close the plug.
Figure 14. Filling the nebulizer with a pre-filled ampoule
4. To start a 30 Minute nebulization cycle, press and release the blue On/Off power button (Figure 4). The green 30 Minute indicator light illuminates to indicate that the 30 Minute nebulization cycle is in progress. 5. To stop the nebulizer at any time, press the On/Off power button. The indicator turns off to indicate that nebulization has stopped. Note: Medication can be added to the Aerogen Solo during nebulization. This does not interrupt nebulization or ventilation. Aerogen® Solo System Instruction Manual
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