Instruction Manual
36 Pages
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Page 1
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Aeroneb® Solo System Instruction Manual
Aeroneb® Solo System Instruction Manual
Introduction
2
System Warnings
4
Assembly & Installation
6
Installation For Use With A Ventilator
10
Installation For Use Off-Ventilator
12
Nebulization Modes
15
Aeroneb Solo Aerosol Flow Rate Calculation
19
Troubleshooting
20
Parts List
22
Warranty
24
Life Of Product
24
Specification Tables
25
Performance
26
Symbols
27
Appendix 1
28
Appendix 1: EMC Tables
29
Aeroneb Solo System Instruction Manual
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Introduction The Aeroneb® Solo System is an iteration of the Aeroneb® Professional Nebulizer System. The indications for use of the Aeroneb® Professional Nebulizer System are given below. The Aeroneb® Solo System consists of the Aeroneb® Solo nebulizer and the Aeroneb® 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 Aeroneb Solo nebulizer is for single patient use only and the Aeroneb® Pro-X controller is for re-use. The Aeroneb Solo System is suitable for intermittent and continuous nebulization of neonate, pediatric and adult patients as described in this manual.
Indications for Use The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult, pediatric and neonate patients as described in the Instruction Manual.
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Aerogen
Aeroneb® Solo System The Aeroneb Solo System includes the following components: 1
2
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4
5
6
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Figure 1. Aeroneb Solo System
1. Aeroneb Solo With Plug 2. T-Piece (Adult)* 3. Aeroneb Pro-X Controller 4. Controller Cable 5. AC/DC Adapter 6. Universal Mounting Bracket & Equipment Mount Adapter 7. Continuous Nebulization Tube Set* 8. Aeroneb Solo Adapter* * Neonate and pediatric adapters, continuous nebulization tube set and Aeroneb Solo Adapter are sold separately.
Aeroneb Solo System Instruction Manual
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System Warnings Read and study all instructions before using the Aeroneb 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 Aeroneb Solo system, as packaged, are not sterile. Inspect all system and accessory parts before use. Do not use if any parts are missing, cracked or damaged, or if there is any foreign matter present. In such cases, contact your Aerogen product 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 Aeroneb Solo components, connectors and accessories specified by Aerogen in this manual. Do not use beyond defined life (see page 24). To avoid the risk of fire, do not use in the presence of flammable substances or flammable anaesthetic mixtures combined with air, oxygen or nitrous oxide. Do not use the Aeroneb Solo in conjunction with the administration of volatile anaesthetics as this may have an adverse effect on the Aeroneb Solo nebulizer or T-piece plastics. Do not use to aerosolize alcohol-based medications, which can ignite in oxygenenriched air under high pressure. Do not autoclave any component or accessory of the Aeroneb Solo system. Do not modify this equipment without authorization from the manufacturer.
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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 vibrating mesh 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.
Aeroneb Solo System Instruction Manual
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Assembly & Installation Aeroneb Solo System Set-Up Perform a functional test of the Aeroneb Solo before use as described in the Functional Test section of this manual (See page 18).
Figure 2. Assembly of Aeroneb Solo System
1. Connect the Aeroneb Solo to the T-piece by pushing the nebulizer firmly onto the T-piece. 2. Insert the Aeroneb Solo and the T-piece into the breathing circuit with the arrow on the T-piece pointing in the direction of the air-flow within the circuit. Note: For use with other accessories, refer to Figure 8, Figure 9 and Figure 10. 3. Connect the Aeroneb Pro-X controller to the Aeroneb Solo using the nebulizer cable. 4. To operate on AC power (the primary mode of operation), connect the Aeroneb Pro-X AC/DC adapter to the Aeroneb Pro-X controller. 5. Plug the adapter into an AC power source. 6. Aeroneb Pro-X 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.
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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. Aeroneb Pro-X Controller and universal mounting bracket configurations
Warnings •
• • •
To ensure uninterrupted operation of the Aeroneb 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 Aeroneb 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.
Aeroneb Solo System Instruction Manual
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Aeroneb Pro-X Controller On/Off Power • 30 Min. - Press & Release • Continuous Mode - 3 Sec. hold from off
Fault Indicator 30 Minute Indicator Continuous Mode Indicator
Battery Status Indicator 9V DC Input
Controller Cable Input Figure 4. Aeroneb Pro-X Controls & indicators Table 1. Aeroneb Pro-X Controls & Indicators
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Control / Indicator
Function
30 Min. Indicator
• Green (steadily lit) = 30 minute nebulization cycle on • Green (flashing) = Low battery power • Nebulizer automatically powers off after 30 minutes have elapsed
Continuous Indicator
• Green (steadily lit) = Continuous nebulization cycle on • Nebulizer does not power off automatically
Fault Indicator
• Amber (steadily lit) = Aeroneb Solo nebulizer disconnected from Aeroneb Pro-X controller • Amber (flashing) = Aeroneb Pro-X drive voltage error
On/Off Power Button
• 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
Battery Status Indicator
• Green = Battery fully charged. • Amber = Battery charging. • No light = Battery in operation.
Aerogen
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.
Cleaning the 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 Aeroneb Pro-X Controller, cable or AC/DC adapter. Do not place the Aeroneb Pro-X 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 Aeroneb 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. F or 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 Aeroneb 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 Aeroneb Solo can connect to 10mm neonate breathing circuits with the 15mm pediatric T-piece and the neonate adapters. This can be positioned approximately 30 cm (12 in.) back from the patient Y (Figure 6).
Figure 6. Connecting to a neonate breathing circuit
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2. The Aeroneb Solo can be placed on the dry side of the humidifier as shown in Figure 7. The Aeroneb Solo can be used with a nasal interface in this configuration.
Figure 7. Aeroneb Solo on dry side of humidifier
3. Follow ventilator manufacturer instructions for performing a leak test after inserting or removing the nebulizer. Warnings • • •
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. Do not use a filter or heat-moisture exchanger (HME) between the nebulizer and patient airway.
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Installation for use Off-Ventilator Use with a Facemask Mask kits, which include a vented elbow and mask elbow, are available separately (see part numbers page 22). 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 8).
Facemask Facemask ElbowElbow
Vented Vented ElbowElbow Patient Patient Upright Upright
Patient Patient Reclined Reclined
Figure 8. Connecting to a mask
Use with a Mouthpiece The Aeroneb Solo is compatible with any standard ISO 22 mm 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 9.
Figure 9. Connecting to a mouthpiece
Warning: To ensure correct nebulization, maintain the nebulizer in a vertical orientation (Figure 8 & Figure 9) 12
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Use with a Nasal Interface The Aeroneb Solo can be used on/off ventilator with a nasal interface when configured with a humidifier (Figure 7).
Aeroneb Solo Adapter The Aeroneb Solo Adapter is an accessory specific to the Aeroneb Solo nebulizer. It facilitates intermittent and continuous nebulization, with optional supply of supplemental oxygen to pediatric and adult patients via mouthpiece. The device can alternatively be used with a facemask, which is not provided. It is a single patient use device which is qualified for 20 intermittent use treatments (at a rate of four 3 ml doses per day over 5 days) or 3 hours of continuous use. Optimal aerosol delivery is achieved with valved mouthpiece or valved aerosol face mask with low/no oxygen flow. Inspect for device integrity and correct valve placement prior to use.
Mouthpiece Face Mask
Aeroneb Solo Adapter Aeroneb Solo
Oxygen Tubing
Figure 10. Assembly of Aeroneb Solo Adapter
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1. Insert Aeroneb Solo nebulizer firmly into Adapter in orientation shown in Figure 10. 2. If supplemental oxygen is required, firmly attach oxygen tubing to Adapter. Note: Oxygen flow rate should be set between 1-6 LPM. 3. If a facemask is required, remove mouthpiece and attach facemask to Adapter. Note: When using an open face mask, a minimum oxygen flow of 1 LPM is required. 4. Add medication to nebulizer. 5. Connect cable to Aeroneb Solo and power on controller. 6. Introduce Adapter to patient and observe aerosol flow to ensure correct operation. 7. Remove excess rainout from Adapter periodically (hourly with continuous nebulization). 8. To ensure optimum performance of the Adapter, remove any residue by rinsing through with sterile water, shake off excess and allow to air dry. Warnings • • • • • • • • • • •
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Do not use with a closed face mask. When using with an open face mask, always use supplemental oxygen flow of 1-6 LPM. Performance of the Adapter may vary depending upon the type of drug and Adapter configuration used. Do not exceed recommended oxygen flow for system. Ensure oxygen connection port or tubing is not occluded. Do not use Adapter without a mouthpiece or facemask. Visually check Adapter post-rinsing to ensure that valves have not become dislodged. Do not cover Adapter valves during use. Do not use Adapter in conjunction with the Aeroneb Pro nebulizer. Do not autoclave any component of the kit. Ensure tubing is safely orientated to prevent strangulation hazard.
Aerogen
Nebulization Modes Intermittent Mode Warnings • • •
To avoid damage to the Aeroneb Solo, do not use a syringe with 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 11). 3. Close the plug.
Figure 11. 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 Aeroneb Solo during nebulization. This does not interrupt nebulization or ventilation.
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Continuous Mode Continuous Nebulization Tube Set The Aerogen Continuous Nebulization Tube Set is an accessory specific to the Aeroneb Solo nebulizer which enables safe continuous infusion of liquid medication for aerosolization. Tethered Cap Tubing (Nebulizer End)
Syringe Cap
A
Tubing Syringe
Tubing (Syringe End)
Figure 12. Continuous Nebulization Tube Set
Note: Place the syringe cap on the syringe after it is filled with medication. 1. Ensure the Aeroneb Solo nebulizer is firmly fitted into the Aeroneb 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. 4. Prime the tubing until the medication reaches end of tubing (Point A). Note: The tubing priming volume is maximum 3.65 mL. 5. Unplug the tethered cap from the Aeroneb Solo nebulizer, but do not remove it from the nebulizer. 6. Screw the nebulizer end of the tubing onto the top of the nebulizer. 7. Insert the syringe filled with medication into the syringe infusion pump (pump not shown in Figure 12) and set the appropriate flow rate (refer to pump manual or manufacturer for guidance). 8. To start a continuous nebulization cycle, press and hold the blue On/Off power 16
Aerogen
button from the off state for at least three seconds. Verify the green, ‘continuous nebulization’ indicator light is on (Figure 4). 9. Observe nebulizer for correct operation. During continuous nebulization, the nebulizer is on continuously and the medication is nebulized on a drop by drop basis. Nebulization should be visible with regular intermittent pauses. Medication level in the nebulizer reservoir should not rise during use. 10. To stop the nebulizer at any time, press the on/off power button. The indicator turns off to indicate that nebulization has stopped. Aerogen’s recommended input rate of medication into the Aeroneb Solo nebulizer during continuous nebulization 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 nebulizer flow rate. For directions on determining flow rates, refer to the Optional Flow Rate Calculation method in the Functional Test section, page 19. Warnings Specific to the Continuous Nebulization Tube Set • • • • • •
• • • •
•
It is important to ensure that the maximum flow rate through the tube set into the nebulizer must not exceed the output rate of the nebulizer. Check for leaks from the system prior to and during use. The graduations on the syringe are for indication use only. Store at room temperature and use product within labelled shelf life. To ensure correct and safe connection between the nebulizer and the medication reservoir, trace the medication tube from the nebulizer back to the medication reservoir to make sure the medication tube is connected to the correct source. The recommended syringe pump software setting with the Aerogen syringe is typically the “BD Plastipak” setting. This must be validated locally before use. Refer to pump manual or manufacturer for guidance. These pumps may also be used in accordance with local hospital or ward policies. Ensure that the tethered silicone plug is attached to the Aeroneb Solo when connecting tube set. Ensure that the tubing is safely orientated to prevent a trip hazard. Rising level of medication in the reservoir may occur if the Aeroneb Solo nebulizer is turned off while the feed system is still on or the nebulizer is not in its recommended orientation. The level of the medication in the reservoir of the Aeroneb Solo nebulizer should be periodically monitored to ensure that the fill rate of medication does not exceed the output rate of the nebulizer. A rising level of medication in the reservoir indicates that the fill rate is exceeding the output rate of the nebulizer. Replace the tube set and syringe when changing the type of medication.
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• • •
Do not connect the tube set and syringe to non-respiratory equipment. Do not clean or sterilize. Do not connect to any nebulizer other than the Aeroneb Solo.
Note: If the mains power is disconnected during a continuous nebulization cycle and reconnected within 10 seconds, the controller shall return to continuous nebulization mode automatically.
Functional Test Perform a functional test of the Aeroneb 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 neb into a circuit or accessory. 1. Visually inspect each part of the System for cracks or damage and replace if any defects are visible. 2. Pour 1-6 mL of normal saline (0.9%) into the nebulizer. 3. Connect the nebulizer to the controller using the controller cable. Connect the AC/DC adapter to the controller and plug the AC/DC adapter into an AC power source. 4. Press and release the blue on/off power button and verify that the green 30 Min. indicator light illuminates and that aerosol is visible. 5. Disconnect the AC/DC adapter from the controller and verify that nebulization continues and that the battery status indicator turns off. 6. Power off the controller. Reconnect the AC/DC adapter to the controller. Press and hold the button for at least three seconds. Verify that the green Continuous indicator light illuminates and that aerosol is visible. 7. Turn the System off and verify that the 30 Min. and Continuous indicators are off.
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Flow Rate Calculation Flow rates may vary between individual Aeroneb Solo nebulizers. The minimum flow rate for all Aeroneb Solo nebulizers is 0.2 mL per minute. In order to calculate the flow rate of an individual Aeroneb Solo nebulizer: 1. Transfer 0.5 mL of normal saline (0.9%) or intended drug into the Aeroneb Solo medication cup. 2. Turn on the nebulizer. 3. Using a stop-watch, measure the length of time it takes from the start of nebulization until all the saline/drug has been nebulized. 4. Calculate the flow rate using the following equations:
Flow rate in mL/min =
Flow rate in mL/hr =
)
))
Volume of normal saline or drug Nebulization time in seconds Volume of normal saline or drug Nebulization time in seconds
Aeroneb Solo System Instruction Manual
)
x 60
)
x 60
)
x 60
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