System Instruction Manual
42 Pages
Preview
Page 1
System Instruction Manual
www.aerogen.com
Contents Introduction
2
Indications for Use
2
System Warnings
5
Assembly & Installation
9
Installation For Use With A Ventilator
12
Nebulization
16
Installation For Use Off-Ventilator
17
Functional Test
19
Cleaning, Disinfection and Sterilization
20
Troubleshooting
26
Warranty
28
Life Of Product
28
Specifications
29
Performance
30
Symbols
31
Appendix 1
32
Appendix 1: EMC Tables
34
Aerogen® Pro System Instruction Manual
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Introduction The Aerogen® Pro System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed medications for inhalation that are approved for use with a general purpose nebulizer. This device can be used by patients on and off mechanical ventilation or other positive pressure breathing assistance. Aerogen® Pro is intended for hospital use only. It is suitable for use by pediatric and adult patients as described in this manual. It incorporates the Aerogen Vibronic® aerosol generator. Aerogen® Pro is designed to operate in-line with standard ventilator circuits and mechanical ventilators. It operates without changing patient ventilator parameters and can be refilled without interrupting ventilation. The controller operates from the AC/DC adapter and can be operated on its internal rechargeable battery for up to 45 minutes when fully charged. The product operates without compressed gas, making it suitable for portable applications.
Indications for Use The Aerogen® Pro 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 Aerogen® Pro System is suitable for use in adult and pediatric patients.
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Aerogen®
Aerogen Pro System The Aerogen Pro System includes the following components: 1
2
5
6
3
4
Figure 1. Aerogen Pro System
1. Nebulizer 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: Device names previously referencing ‘Aeroneb’ are now referencing ‘Aerogen’. Visit www.aerogen.com for full parts list.
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1. The nebulizer holds up to 10 mL of liquid medication. The nebulizer is translucent to allow visual monitoring of medication levels and aerosolization. When the nebulizer is connected into the breathing circuit, the filler cap can be opened or removed from the nebulizer without causing loss of circuit pressure. Within the nebulizer 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 aerosolize medication. Gravity brings the medication in contact with the aerosol generator; the liquid is then drawn through the aperture plate and converted into an aerosol. 2. The T-piece securely connects the nebulizer into the breathing circuit and can be easily removed for cleaning. The T-piece connections are standard male and female 22 mm ISO conical ports and connect to standard patient breathing circuits. 3, 4, 5. The controller can operate from the AC/DC Adapter or the internal rechargeable battery. The controller includes an On/Off power button and sockets for the controller cable and the AC/DC Adapter. The controller also includes indicators for nebulization cycle selection (15 or 30 minutes), battery charge status and fault conditions. 6. A Universal Mounting Bracket clamps the controller to standard IV poles and medical rail systems. 7. An Equipment Mount Adapter mounts the controller on Standard Equipment Mounts. Note: Pediatric T-piece, Mask Adapter Kits, Elbow Connectors and Mouthpiece are sold separately.
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Aerogen®
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 nebulizer by regularly verifying aerosol is visible and no flashing indicator lights. Do not use a filter or heat-moisture exchanger (HME) between the nebulizer and patient airway. Do not attach a continuous supply of medication to the nebulizer; the device operates in 15 or 30 minute cycles. Clean, sterilize, assemble and perform a functional test (page 19) according to the instructions in this manual before first use and between patients. Do not place the controller in an incubator during use. To avoid exhaled medication affecting the ventilator, follow ventilator manufacturer’s recommendations for use of a bacterial filter in the expiratory limb of a breathing circuit. To ensure optimum drug administration, consult the drug manufacturer’s instructions regarding suitability for nebulization. Do not use in the presence of flammable substances or a flammable anaesthetic mixture combined with air or with 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 modify this equipment without the authorization of the manufacturer. Disconnect the nebulizer from controller before cleaning.
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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 nebulizer or the controller. Do not use in the presence of devices generating high electromagnetic fields such as magnetic resonance imaging (MRI) equipment. The Aerogen Pro controller contains a nickel metal hydride (NiMH) rechargeable battery, which should be disposed of in accordance with local governing restrictions at the end of its useful life. To avoid damage to the nebulizer: •• Prior to use, autoclave according to specified directions and temperature given in the Cleaning, Disinfection and Sterilization section of this Instruction Manual only. Any deviation from directions given in this Instruction Manual may cause damage to the nebulizer and render it inoperable. •• 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 use abrasive or sharp tools to clean the nebulizer.
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Aerogen®
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
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Table 1. Aerogen Pro Controls & Indicators Control / Indicator
Function •
15 Min. Indicator
• • •
Green (steadily lit) = 15 Minute nebulization cycle on Green (flashing) = Low battery power Nebulizer automatically powers off after 15 minutes have elapsed Green (steadily lit) = 30 Minute nebulization cycle on Green (flashing) = Low battery power Nebulizer automatically powers off after 30 minutes have elapsed
30 Min. Indicator
• •
Error Indicator
•
Amber = Faulty electrical connection
•
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 at least 3 seconds from off Pressing during nebulization turns off power to the nebulizer
On/Off Power Button
• •
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.
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Aerogen®
Assembly & Installation Aerogen Pro System Set-Up Clean and sterilize the nebulizer and T-piece(s) as described in the Cleaning, Disinfection and Sterilization section of this manual. Note: The nebulizer and T-piece, as packaged, are not sterile. Perform a functional test of Aerogen Pro before use and between 1 patients as described in the Funtional Test section of this manual (see page 19). Insert the filler cap into the opening on the nebulizer. 2 Connect the nebulizer to the T-piece by pushing the nebulizer firmly 3 onto the T-piece (Figure 3).
Figure 3. Connecting nebulizer to T-piece
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Connect the Aerogen Pro controller and the nebulizer together using the controller cable (Figure 4).
Figure 4. Connecting controller and nebulizer
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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
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Aerogen®
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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 clips are not available, ensure that all cables are routed safely.
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Installation for use with a Ventilator Connection to a Breathing Circuit 1. For adult breathing circuits, connect the nebulizer 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 For pediatric breathing circuits, connect the nebulizer with the pediatric T-piece into the inspiratory limb of the breathing circuit before the patient Y (Figure 7).
Figure 7. Connecting to a 12 mm I.D. pediatric breathing circuit
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Figure 8. Alternative pediatric breathing circuit using 12 mm Male/12 mm Female T-piece
Alternatively connect the nebulizer with the pediatric T-piece and the adapters approximately 30 cm (12 in.) back from the patient Y (Figure 7). Alternatively connect the nebulizer with the 22F/10F/10M T-piece 30 cm (12 in.) back from the patient Y (Figure 8). 2. Always perform a leak test of the breathing circuit after inserting or removing the nebulizer. Follow ventilator manufacturer instructions for performing a leak test. 3. Use the universal mounting bracket to attach the controller to an IV pole or bed rail in either a vertical or horizontal orientation (Figure 9). Do not over-tighten knob. Where a standard equipment mount is available, use the equipment mount adapter to support the controller (Figure 9).
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Standard Equipment Mount
Controller and Vertical Universal Mounting Bracket
Controller and Horizontal Universal Mounting Bracket
Equipment Mount Adapter
Figure 9. Aerogen Pro controller and universal mounting bracket configurations
Warnings •
• • •
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Always maintain the nebulizer in a vertical orientation (with the filler cap uppermost) while in the patient circuit (Figures 6, 7, & 8). This orientation prevents condensate from blocking the nebulizer and ensures proper nebulization. Always visually inspect the nebulizer prior to placing in the ventilator circuit to assure that no secretions are blocking the Aerogen Vibronic® aerosol generator. When removing the nebulizer from the patient circuit always replace the T-piece plug to maintain circuit pressure. 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.
Aerogen®
Adding Medication •• Open the filler cap tab on the nebulizer. •• Use a pre-filled ampoule or syringe to add medication into the filler port of the nebulizer (Figure 10). •• Close the filler cap tab. Warning: To avoid damage to the nebulizer, do not use a syringe with a needle. The maximum capacity of the nebulizer is 10 mL. Do not fill the nebulizer beyond the maximum fill indication point (Figure 10). The underside of the filler cap represents maximum fill indication point.
Max. fill indication point
Figure 10. Filling the nebulizer with a pre-filled ampoule
Note: Medication can be added in this manner during nebulization. This does not interrupt nebulization or ventilation.
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Nebulization For doses less than or equal to 3 mL. 1. To start a 15 Minute nebulization cycle, add the medication and press and release the blue On/Off power button (Figure 2). The green 15 Min. indicator lights to indicate that the 15 Minute nebulization cycle is in progress. For doses greater than 3 mL. 2. To start a 30 Minute nebulization cycle, add the medication and press and hold the blue On/Off power button for at least three seconds. The green 30 Min. indicator lights to indicate that the 30 Minute nebulization cycle is in progress. 3. To stop the nebulizer at any time, press the On/Off power button. The indicator turns off to indicate that nebulization has stopped. Note: When delivering a dose greater than 3 mL, select the 30 Minute cycle.
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Aerogen®
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). Contact your sales representative for ordering information. 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
Warning: To ensure correct nebulization, maintain the nebulizer in a vertical orientation (Figure 11).
Use with a Mouthpiece The Aerogen Pro works with any standard ISO 22 mm nebulizer mouthpiece inserted into the adult T-piece.
Figure 12. Connecting to a mouthpiece Aerogen® Pro System Instruction Manual
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When using a mouthpiece, connect the nebulizer to the T-piece as shown in Figure 3 and then connect the T-piece to the mouthpiece by pushing the parts firmly together (Figure 12). Warning: To ensure correct nebulization, maintain the nebulizer in a vertical orientation (Figure 12).
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Aerogen®
Functional Test Perform a functional test of the Aerogen Pro System prior to first use, after each sterilization before each patient use or at any time to verify proper operation. Follow these steps: 1. Visually inspect each part of the system for cracks or damage and replace if any defects are visible. 2. Pour 1-5 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 15 Min. indicator light illuminates and that aerosol is visible. 5. Disconnect the nebulizer from the controller. Verify that the amber Error Indicator lights. Reconnect the nebulizer to the controller. 6. Press the On/Off power button again to turn the system off. Press and hold the button for at least three seconds. Verify that the green 30 Min. indicator light illuminates and that aerosol is visible. 7. Disconnect the controller from the AC/DC Adapter and verify that nebulization continues and that the battery status indicator turns off. 8. Turn the system off and verify that the 15 Min. and 30 Min. indicators are off. 9. Discard any remaining liquid before patient use.
Aerogen® Pro System Instruction Manual
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