Instruction Manual
38 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
13
Installation For Use Off-Ventilator
14
Nebulisation Modes
17
Functional Test
21
Aerogen Solo Aerosol Flow Rate Calculation
22
Troubleshooting
23
Warranty
25
Life Of Product
25
Specifications
26
Performance
27
Symbols
28
Appendix 1
29
Appendix 1: EMC Tables
31
Aerogen® Solo System Instruction Manual
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Introduction The Aerogen® Solo System is an iteration of the Aerogen® Pro System. The indications for use of the Aerogen® Pro System are given below. The Aerogen® Solo System consists of the Aerogen® Solo nebuliser and the Aerogen® Pro-X Controller. It is intended for hospital use only to nebulise physician-prescribed medications for inhalation which are approved for use with a general purpose nebuliser. The Aerogen® Solo nebuliser 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 nebulisation of neonate, paediatric and adult patients as described in this manual.
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. The Aerogen Pro System is suitable for use in adult, paediatric and neonate patients as described in the Instruction Manual.
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Aerogen Solo System The Aerogen Solo System includes the following components: 1
2
3
4
5
6
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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* * Neonate and paediatric adapters, Continuous Nebulization Tube Set and Aerogen Ultra are sold separately. Visit www.aerogen.com for full parts list. Note: Device names previously referencing ‘Aeroneb’ are now referencing ‘Aerogen’. The Aerogen Ultra was also previously known as Aeroneb Solo Adapter. 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 nebuliser. Consult drug manufacturer’s instructions regarding suitability for nebulisation. Use only with Aerogen Solo components, connectors and accessories specified by Aerogen in this instruction manual. Do not use beyond defined life (see page 25). Do not use in the presence of flammable substances or flammable anaesthetic mixtures combined with air, oxygen or nitrous oxide. To avoid the risk of fire, do not use to aerosolise 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 authorisation of the manufacturer. Do not use or store outside of specified environmental conditions. To avoid damage to the nebuliser: •• Do not apply undue pressure to the domed aperture plate in the centre of the nebuliser. •• 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 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. Aerogen have determined that, using anaesthetic ventilators, the following volatile anaesthetic agents are compatible under the stated conditions below: Anaesthetic Agent
Proprietary Name
Maximum Percentage of Anaesthetic
Maximum Duration of Exposure
Isoflurane
FORANE®
3.5 %
12 hours
Sevoflurane
SEVOFLURANE
8%
12 hours
Desflurane
SUPRANE®
10 %
12 hours
®
The Aerogen Solo should not be used after exposure to volatile anaesthetic.
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 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. 2. Insert the Aerogen Solo and the T-piece into the breathing circuit. Note: For use with other accessories, refer to Figure 9, Figure 10 and Figure 11. 3. Connect the Aerogen Pro-X Controller to the Aerogen Solo using the nebuliser 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
• Green (steadily lit) = 30 Minute nebulisation cycle on • Green (flashing) = Low battery power • Nebuliser automatically powers off after 30 minutes have elapsed
Continuous Indicator
• Green (steadily lit) = Continuous nebulisation cycle on • Nebuliser does not power off automatically
Error Indicator
• Amber (steadily lit) = Aerogen Solo nebuliser disconnected from Aerogen Pro-X Controller • Amber (flashing) = Aerogen 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 nebulisation turns off power to the nebuliser
Battery Status Indicator
• 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.
Aerogen® Solo System Instruction Manual
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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 nebuliser 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 nebuliser 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 paediatric breathing circuits connect the nebuliser with the paediatric T-piece into the inspiratory limb of the breathing circuit before the patient Y. The Aerogen Solo can connect to 10mm neonate breathing circuits with the 15mm paediatric 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 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. Follow ventilator manufacturer instructions for performing a leak test after inserting or removing the nebuliser.
Warnings • • •
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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 nebuliser and patient airway.
Aerogen®
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
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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 nebuliser by firmly pushing the parts together. 2. Rotate the vented elbow to suit the position of the patient (Figure 9).
FaceFace MaskMask Elbow Elbow
Vented Vented Elbow Elbow Patient Patient Upright Upright
Patient Patient Reclined Reclined
Figure 9. Connecting to a mask
Use with a Mouthpiece The Aerogen Solo is compatible with any standard ISO 22 mm 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.
Figure 10. Connecting to a mouthpiece
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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. It facilitates intermittent and continuous nebulisation, with optional supply of supplemental oxygen to paediatric and adult patients via mouthpiece. The device can alternatively be used with a face mask, 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 a valved mouthpiece or valved aerosol face mask with low/no oxygen flow.
Mouthpiece Face Mask
Aerogen Ultra Aerogen Solo
Oxygen Tubing
Figure 11. Assembly of Aerogen Ultra Aerogen® Solo System Instruction Manual
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Inspect for device integrity and correct valve placement prior to use. 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. Note: When using an open face mask, a minimum oxygen flow of 1 LPM is required. 4. Add medication to nebuliser. 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 nebulisation). 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.
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 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 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. Do not autoclave any component of the kit. Ensure tubing is safely orientated to prevent strangulation hazard. Aerogen®
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.
For intermittent doses less than or equal to 6 mL: 1. Open the plug on the nebuliser. 2. Use a pre-filled ampoule or syringe to add medication into the filler port of the nebuliser (Figure 12). 3. Close the plug.
Figure 12. Filling the nebuliser with a pre-filled ampoule
4. To start a 30 Minute nebulisation 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 nebulisation cycle is in progress. 5. To stop the nebuliser at any time, press the On/Off power button. The indicator turns off to indicate that nebulisation has stopped. Note: Medication can be added to the Aerogen Solo during nebulisation. This does not interrupt nebulisation or ventilation. Aerogen® Solo System Instruction Manual
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Continuous Mode
Continuous Nebulization Tube Set The Aerogen Continuous Nebulization Tube Set is an accessory specific to the Aerogen Solo nebuliser which enables safe continuous infusion of liquid medication for aerosolisation. Note: Place the syringe cap on the syringe after it is filled with medication. Tethered Silicone Plug Tubing (Nebuliser End)
Syringe Cap
A
Tubing Syringe
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. 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 silicone plug from the Aerogen Solo nebuliser, but do not remove it from the nebuliser. 6. Screw the nebuliser end of the tubing onto the top of the nebuliser.
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7. Insert the syringe filled with medication into the syringe infusion pump (pump not shown in Figure 13) and set the appropriate flow rate (refer to pump manual or manufacturer for guidance). 8. To start a continuous nebulisation cycle, press and hold the blue On/Off power button from the off state for at least three seconds. Verify the green, ‘Continuous Nebulization’ indicator light is on (Figure 4). 9. Observe nebuliser for correct operation. During continuous nebulisation, the nebuliser is on continuously and the medication is nebulised on a drop by drop basis. Nebulisation should be visible with regular intermittent pauses. Medication level in the nebuliser reservoir should not rise during use. 10. To stop the nebuliser at any time, press the On/Off power button. The indicator turns off to indicate that nebulisation has stopped. 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.
Warnings Specific to the Continuous Nebulization Tube Set • • • • •
•
It is important to ensure that the maximum flow rate through the tube set into the nebuliser must not exceed the output rate of the nebuliser. 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 nebuliser and the medication reservoir, trace the medication tube from the nebuliser 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. Aerogen® Solo System Instruction Manual
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