980 Integrated Nebulizer Option Addendum Rev A Jan 2021

U.S. Patents: www.covidien.com/patents. © 2019 Covidien. All rights reserved. COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. ™* brands are trademarks of their respective owner. Other brands are trademarks of a Covidien company. The information contained in this addendum is the sole property of Covidien and may not be duplicated without permission. This addendum may be revised or replaced by Covidien at any time and without notice. Ensure this addendum is the most current applicable version. If in doubt, contact Covidien’s technical support department. **For additional information, refer to 30-1572 Aerogen™* Solo and Aerogen™* Pro Instruction Integration Manual. While the information set forth herein is believed to be accurate, it is not a substitute for the exercise of professional judgment. The ventilator should be operated and serviced only by trained professionals. Covidien’s sole responsibility with respect to the ventilator and software, and its use, is as stated in the limited warranty provided. Nothing in this document shall limit or restrict in any way Covidien’s right to revise or otherwise change or modify the equipment (including its software) described herein, without notice. In the absence of an express, written agreement to the contrary, Covidien has no obligation to furnish any such revisions, changes, or modifications to the owner or user of the equipment (including its software) described herein. Covidien is a Medtronic company.

Symbols This device is for sale by or on the order of a physician Manufacturer-Ventilator manufacturer

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1. Integrated Nebulizer 1.1. Overview This addendum describes the operation of the Aerogen™* Pro nebulizer and Aerogen™* Solo nebulizer options for the Puritan Bennett™ 980 series Ventilator. The Aerogen™* Pro is a reusable nebulizer, and the Aerogen™* Solo is a single-patient use nebulizer. Both nebulizers are manufactured by Aerogen™* Limited. For complete cleaning, accessory compatibility, warnings, cautions, instructions and specifications, and patient selection for the nebulizers, see 30-1572-Aerogen™* Solo and Aerogen™* Pro Instruction Integration Manual. When the nebulizer is connected to the ventilator, the ventilator’s nebulizer settings determine whether nebulization is continuous or timed. Note: Only the Aerogen™* Solo nebulizer can be used for continuous nebulization. Nebulizer control is achieved via a printed circuit board assembly (PCBA) and cable and is enabled through the ventilator’s graphic user interface (GUI). The nebulizer receives its power from the ventilator. The GUI indicates the nebulizer’s configuration, functional status, and remaining operational time. The nebulizer kit includes the following items: •

Aerogen™* PCBA

•

Medtronic ESD (Electrostatic Discharge) PCBA

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Medtronic internal cable

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Aerogen™* external cable

•

Instructions for Use (IFU)

•

Starter Kit ○

Aerogen™* Solo II

○

Adult T-Piece Assembly

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T-Piece Pediatric/Neonatal**

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Plug T-Piece

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Connector 15-10-7.5

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Connector 15/10

The nebulizer does not require modification of the ventilator’s settings and can be refilled without interrupting patient ventilation.

1.2. Intended Use The Integrated Aerogen™* Nebulizer option is intended to power and control the Aerogen™* nebulizer for the purpose of nebulizing physician-prescribed solutions that are approved for use with a general-purpose nebulizer for delivery to patients.

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1.3. Safety Terms This section contains safety information for users who should always exercise appropriate caution while using the ventilator. Table 1. Safety Terms Term

Definition

Warning

Warnings alert users to potential serious outcomes (death, injury, or adverse events) to the patient, user, or environment.

Caution

Cautions alert users to exercise appropriate care for safe and effective use of the product.

Note

Notes provide additional guidelines or information.

1.4. General Warnings and Cautions Warnings:

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•

To ensure appropriate treatment, only trained personnel should operate the nebulizer.

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Use only with components approved by Aerogen™* or Covidien (see Table 5 and Table 2). Use of other components may prevent proper nebulization and medication delivery.

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Do not modify the equipment. Unauthorized modifications may prevent proper nebulization and medication delivery.

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Do not apply excessive or unnecessary pressure to the domed aperture plate in the center of the nebulizer. Doing so may prevent proper nebulization and medication delivery.

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To ensure proper nebulization, 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 Medtronic representative.

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Do not drop the nebulizer. Dropping the nebulizer may damage the device and prevent proper nebulization and medication delivery.

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Only use physician-prescribed solutions that are approved for use with a generalpurpose nebulizer. Consult the drug manufacturer’s instructions regarding suitability for nebulization.

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Do not use the nebulizer between the breathing circuit wye and the patient. The total combined volume of the nebulizer, T-piece and HME may increase the dead-space to the extent that it adversely impacts the ventilatory parameters of the patient.

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Do not use a filter or HME between the nebulizer and the patient airway or the medication may be trapped in the filter or HME.

•

Use only an HME approved for use with nebulizers. Using incompatible HMEs may prevent medication delivery.

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Use of a nebulizer can lead to an increase in the resistance of inspiratory and expiratory filters. Monitor the filters frequently for increased resistance or blockage.

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•

Condensate can collect and occlude ventilator circuits. Always position ventilator circuits so that fluid condensate drains away from the patient to maintain prescribed ventilation.

•

When using aerosolized medications, select and connect additional filtration, as required, to the from patient port of the ventilator based on the nebulization therapy being delivered. Refer to the applicable medication and filter instructions for use to ensure compatibility and filtration efficacy. Insufficient filtration may result in degradation of the expiratory flow sensing elements, potentially impacting breath triggering or spirometry.

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Do not use the nebulizer to aerosolize alcohol-based medications, which can ignite in oxygen- enriched air under high pressure.

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During use, observe that the nebulizer is functioning correctly by regularly verifying aerosol is visible.

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Never attempt to reuse single-patient use components or accessories. Doing so increases risk of cross-contamination and reprocessing of single-patient use components or accessories may compromise ventilation.

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Assemble and perform a functional test according to the instructions in this addendum. See page 19 for the Aerogen™* Pro nebulizer and page 8 for the Aerogen™* Solo nebulizer prior to use.

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Using the nebulizer while the patient is monitored with the proximal flow sensor, may negatively affect the flow sensor accuracy due to nebulized medication moisture or particle deposition on or around the flow sensor.

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Do not use in an environment with electromagnetic interference levels higher than specified in EN 60601-1-2 or nebulized medication delivery may be compromised.

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Do not use or store outside of the specified environmental conditions (see Table 6 for the Pro nebulizer and Table 3 for the Solo nebulizer).

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Do not push the aerosol generator out of the fitting in which it is housed. Doing so will render the nebulizer unusable.

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To optimize medicated aerosol delivery, the nebulizer therapy setting should be consistent with physician’s prescriptions.

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To avoid damaging the nebulizer, do not use a syringe with a needle to add medication.

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Do not position the nebulizer cable in any manner that may cause entanglement which could lead to a tripping hazard, hypercarbia or hypoxemia. Use the cable management clips to mitigate this risk.

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If the ETCO2 option is in use, using the nebulizer may affect the capnography reading. Aerosolized medication may obscure the capnography sensor windows, causing the sensor to provide inaccurate readings.

Cautions: •

To avoid damaging the nebulizer, do not apply excessive or unnecessary pressure to the domed aperture plate in the center of the nebulizer. Operator's Manual Addendum–Integrated Nebulizer

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To avoid mechanical or electrical damage, do not drop the nebulizer.

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Do not immerse or autoclave the external cable.

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Follow local laws and recycling plans regarding disposal or recycling of components and packaging.

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Use only with components approved by Aerogen™* or Covidien (Table 5 and Table 2). Use of other components may result in increased electromagnetic emissions or decreased immunity of the nebulizer.

•

Nebulizer use may be adversely affected by electromagnetic interference from portable and mobile radio frequency communication devices.

Note: In the United States, US federal law restricts this device to sale by or on the order of a physician.

1.5. Aerogen™* Solo Nebulizer 1.5.1. Device Description The Aerogen™* Solo nebulizer can be used in-line on the ventilator's breathing circuit. The Aerogen™* Solo nebulizer unit is also transparent to allow visual monitoring of medication levels and aerosolization. When the nebulizer unit is connected into the breathing circuit, the silicone plug can be opened or removed from the nebulizer unit without causing a loss of circuit pressure. The T-piece securely connects the nebulizer unit into the breathing circuit. Medtronic recommends that the Aerogen™* Solo nebulizer be used in conjunction with a relevant disposable T-piece. See Table 2, page 14 for a list of orderable parts for the Aerogen™* Solo nebulizer. Pediatric and neonatal** T-pieces are available separately.

1.5.2. Aerogen™* Solo Nebulizer Assembly and Installation Warning: As packaged, the nebulizer unit and T-adapter are not sterile. To assemble the Aerogen™* Solo nebulizer: Connect the nebulizer unit to the T-piece by pushing it firmly onto the T-piece, as shown in Figure 1.

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Figure 1. Assembling the Aerogen™* Solo Nebulizer

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To install the Aerogen™* Solo nebulizer on a humidifier: Note: See Figure 2 for item locations. 1. Connect a T-piece (item 2) to the inlet (dry) side of the humidifier used in the ventilator breathing system. 2. Connect the nebulizer (item 1) to the T-piece. 3. Attach the humidifier tubing to the nebulizer T-piece. 4. Attach the inspiratory limb (item 3) of the breathing circuit to the outlet (wet) fitting of the humidifier. Figure 2. Connecting the Solo Nebulizer to a Humidifier

3. Breathing circuit inspiratory limb 1. Solo nebulizer 2. T-piece To install the Aerogen™* Solo nebulizer in the breathing circuit: 1. Connect the nebulizer for each size as follows: •

For adult breathing circuits, connect the nebulizer unit with adult T-piece into the inspiratory limb of the breathing circuit upstream of the patient wye (Figure 3). Operator's Manual Addendum–Integrated Nebulizer

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Figure 3. Connecting to an Adult Breathing Circuit

1. Circuit wye 2. Inspiratory flow from the ventilator •

3. Adult T-piece

For pediatric breathing circuits, connect the nebulizer unit with pediatric Tpiece into the inspiratory limb of the breathing circuit upstream of the patient wye, as shown in Figure 4. Figure 4. Connecting to a Pediatric Breathing Circuit

1. Circuit wye 2. Inspiratory flow from the ventilator •

3. Pediatric/Neonatal** T-Piece

For neonatal** breathing circuits, connect the nebulizer unit with the pediatric T-piece and the neonatal** adapters approximately 30cm (12 in.) back from the patient wye (Figure 5 ). Alternatively connect the nebulizer with the neonatal** T-piece 30 cm (12 in.) back from the patient wye (Figure 6).

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Figure 5. Connecting to a Neonatal** Breathing Circuit

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1. Circuit wye 2. Inspiratory flow from the ventilator

3. Pediatric/Neonatal** T-Piece 4. Neonatal** adapters

Figure 6. Alternative Neonatal** Breathing Circuit Connections Using a Neonatal** T-piece

1. Circuit wye 3. Pediatric/Neonatal** T-Piece 2. Inspiratory flow from the ventilator 2. Always perform SST after inserting or removing the nebulizer and T-adapter from the breathing circuit to check for leaks and to recalculate circuit compliance and resistance. Follow the instructions given in the Puritan Bennett™ 980 Series Ventilator Operator’s Manual. 3. Verify the Aerogen™* Solo nebulizer, cable, and connectors are not damaged in any way. 4. Connect one end of the external cable to the Aerogen™* Solo nebulizer. 5. Open the connector panel door and firmly attach the Aerogen™* external cable connector to the lower port in the breath delivery unit's front connector port labeled, Aerogen™* Nebulizer (see Figure 7).

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Figure 7. External Cable Connection to the Ventilator

1.

6.

External cable: connect one end to the Aerogen™* nebulizer port on the ventilator; connect the other end to the Aerogen™* Solo nebulizer's electrical connection port.

Perform a functional test of the assembly, as described on Aerogen™* Solo Nebulizer Functional Test, page 8.

1.5.3. Aerogen™* Solo Nebulizer Functional Test Perform a functional test of the Aerogen™* Solo nebulizer prior to first use or at any time to verify proper operation. To perform a functional test of the Aerogen™* Solo nebulizer: 1. Visually inspect each part of the nebulizer for cracks or damage and replace if any defects are visible. 2. Pour 1 mL to 6 mL of normal saline (0.9%) into the nebulizer unit. 3. Connect the nebulizer to the ventilator using the Aerogen™* cable. 4. Touch the nebulizer icon on the GUI. A dialog appears (Figure 8).

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Figure 8. GUI Solo Nebulizer Icon

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5. 6. 7. 8.

Touch the Solo button. Touch START. Observe the nebulizer to verify that aerosol is visible. Touch Stop to turn off the nebulizer.

1.5.4. Adding Medication Caution: To avoid damage to the nebulizer unit, do not fill the unit using a syringe with a needle. To add medication to the nebulizer: 1. Open the plug on the Aerogen™* Solo nebulizer. 2. Use a pre-filled ampule or syringe to add medication into the filler port, as shown in Figure 9. 3. Close the plug. Note: Medication can also be added in this manner to either nebulizer during nebulization. This does not interrupt nebulization or ventilation.

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Figure 9. Filling the Aerogen™* Solo Nebulizer with Medication

Warning: The maximum fill capacity of the Aerogen™* Solo nebulizer unit is 6 mL. Do not overfill the Aerogen™* Solo nebulizer. Over filling may prevent proper nebulization and medication delivery.

1.5.5. Nebulization The GUI displays an icon in the constant access area enabling nebulization, and provides the following choices for nebulization (Figure 10).

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Figure 10. Solo Nebulizer Dialog Buttons

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1. Type of nebulizer (Pro or Solo). 5. 2. Timed nebulization cycle-the timed cycle operates between 5 minutes and 60 minutes in 5-minute increments. The default nebulization 6. time is 15 minutes. When the nebulizer’s operating time is specified, 7. the remaining nebulization time is displayed in minutes. 3. Continuous nebulization-Allows the clinician to deliver the medication continuously, instead of using a timed nebulization cycle. 4. Close-touching Close dismisses the nebulizer dialog.

Extend-an Extend button appears on the dialog after starting nebulization. Touching Extend resets the timer for whatever interval is set. Stop-touching Stop, stops nebulization. START-touching START starts nebulization.

The ventilator displays alarms indicating when a cable has become disconnected, or when the nebulizer unit is inoperable. The clinician should take appropriate action when any of these messages appear. See Table 8, page 26 for information on alarms. Note: Prior to starting nebulization, calculate the time in minutes required for nebulization by dividing the required dosage in mL by the flow rate specified in Table 4, page 14.

1.5.5.1. Timed Nebulization To perform a timed nebulization cycle: 1. Add the medication. 2. 3.

Touch the nebulizer icon. Touch the Solo button. Operator's Manual Addendum–Integrated Nebulizer

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4. 5. 6. 7. 8.

Touch the Time button and turn the knob to the desired nebulization time. Touch START. Allow the nebulizer to deliver the medication for the allotted time. To extend the nebulization time by 15 minutes, touch the Extend button on the nebulizer dialog (Figure 11). Touch Stop, to stop the nebulizer. Figure 11. Solo Nebulizer Dialog Stop and Extend Buttons

1.5.5.2. Continuous Nebulization Note: To use the Aerogen™* Solo nebulizer in continuous mode, use a syringe pump and tube set per Table 2. Warnings: •

For correct setup and usage, read the instructions for use (IFUs) that accompany the syringe pump and tube set. Only trained medical personnel should operate the nebulizer, continuous nebulization tube set, and syringe pump.

•

The Aerogen™* Solo nebulizer is for single-patient use only and is not to be used on more than one patient to prevent cross-contamination.

To perform a continuous nebulization cycle: 1. Prime the syringe and connect it to the nebulizer according to the IFU that accompanies the continuous nebulizer tube set (CNTS). Note: The tubing priming volume is 3.65 mL (maximum). 2. 3. 4.

Touch the nebulizer icon on the GUI. Touch the Solo button. Touch the continuous nebulization button (∞) (Figure 12).

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Figure 12. Solo Dialog-Continuous Nebulization Button

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5. 6.

7.

8.

Touch START. Observe the nebulizer for proper 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. The medication level in the nebulizer reservoir should not rise during use. Allow the nebulizer to deliver the medication. Note: When delivering medication in continuous mode, the elapsed nebulization treatment time is displayed in hours:minutes. To stop the nebulizer, touch the nebulizer icon on the GUI, then touch the Stop button. Note: When the medication reservoir is empty, manually stop the nebulizer by touching the Stop button, as the nebulizer does not automatically shut off (Figure 11).

1.5.6. Product Life The Aerogen™* Solo nebulizer has a defined life. The Aerogen™* Solo nebulizer has been validated for timed use for a maximum of 28 days based on a usage profile of four treatments per day. For continuous use, the Aerogen™* Solo nebulizer and the continuous nebulization tube set have been validated for a maximum of 7 days. Warning: Use in excess of these periods may result in decreased nebulizer product life, preventing nebulization and medication delivery.

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1.5.7. Aerogen™* Solo Nebulizer Orderable Parts Table 2. Aerogen™* Solo Nebulizer Orderable Parts Description

Part number

T-piece (package of 10)

AG-AS3010

Pediatric T-adapter (package of 10)

AG-AS3020

Pediatric T-adapter & neonate** adapter

AG-AS3025

Neonatal** T-adapter (package of 10)

AG-AS3035

Neonatal** T-piece kit

AG-AS3036

Nebulizer assembly (package of 5)

AG-AS3100

Solo continuous nebulization tube set

AG-AS3075

Continuous nebulization syringe

AG-AS3085

Convenience pack (includes 5 solo nebulizers, adult Tadapters, and Luer adapters)

AG-AS3300

Convenience pack (includes 10 solo nebulizers, adult Tadapters, and Luer adapters)

AG-AS3350

Luer adapter

AG-AS3400

T-piece plug (package of 10)

AG-AS3450

Cable management clips

10084775

External nebulizer cable

AG-AP1085

1.5.8. Specifications 1.5.8.1. Environmental Characteristics Table 3. PB980 Ventilator System with Integrated Nebulizer Controller Environmental Specifications Specifications

Characteristic

Operating

Storage

Temperature

10°C (50°F) up to 40°C (104°F)

–20°C (–4°F) to 70°C (158°F)

Atmospheric pressure (hPa)

700 to 1060

500 to 1060

Relative humidity (%)

10 to 95

10 to 95

Noise level (A-weighted sound pres- sure level)

<35 dB measured at 0.3 m

N/A

1.5.8.2. Performance The Aerogen™* Solo nebulizer maintains specified operating characteristics at circuit pressures up to 90 cmH2O (Table 3). Table 4. Aerogen™* Solo Nebulizer Performance Specifications Characteristic

Specifications

Flow rate

>0.2 mL/min (average ~ 0.38 mL/min)

Particle size as measured with the Andersen Cascade Impactor

Specification range: 1µm to 5 µm Average tested: 3.1 µm

As measured with the Marple 298 Cascade Impactor (non-US only):

Specification Range: 1.5-6.2 μm Average Tested: 3.9 μm

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Table 4. Aerogen™* Solo Nebulizer Performance Specifications (continued) Characteristic

Specifications

Aerosol output rate

0.30 mL/min

Aerosol output

1.02 mL emitted of 2.0 mL dose

Residual volume

<0.1 mL for 3 mL dose

Per EN13544-1:

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Performance may vary depending on the type of drug and nebulizer unit used. For additional information performance-related information, contact Aerogen™* (US: +1 866 423 7643, International: +353 91 540 400). The temperature of the medication will not rise more than 10°C (18°F) above ambient temperature during normal use. Representative particle size distribution for Albuterol per EN 13544-1 is shown in Figure 13. Figure 13. Albuterol Particle Size Distribution

1. Cumulative mass %

2. Aerodynamic size (µm)

1.6. Aerogen™* Pro Nebulizer (Sold Separately) •

Warning: To prevent cross-contamination with reusable nebulizers, clean, sterilize, assemble, and perform a functional test according to the Aerogen™* Pro nebulizer IFU before first use and between patients. Otherwise, assemble and perform a functional test according to the instructions given in this addendum before first use.

•

Warning: Do not use abrasive or sharp tools to clean the nebulizer. Doing so may damage the nebulizer and prevent proper nebulization and medication delivery.

•

Warning: Do not attach a continuous supply of medication to the Aerogen™* Pro nebulizer; only the Aerogen™* Solo nebulizer is designed for continuous use.

1.6.1. Device Description Like the Aerogen™* Solo nebulizer, the Aerogen™* Pro nebulizer can be used in-line on the ventilator's breathing circuit. The nebulizer unit is transparent to allow the user to visually monitor medication levels and aerosolization. When the nebulizer unit is connected into the breathing circuit, the filler cap can be opened or removed from the nebulizer unit without causing a loss of circuit pressure. Operator's Manual Addendum–Integrated Nebulizer

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The nebulizer's operational time can be configured from 5 minutes to 60 minutes in 5minute increments. When the nebulizer’s operating time is specified, the remaining nebulization time is displayed in minutes. The T-adapter securely connects the nebulizer unit into the breathing circuit and can be easily removed for cleaning. Pediatric T-adapters and neonatal** adapters are available separately.

1.6.2. Assembly and Installation To install the Aerogen™* Pro nebulizer in the breathing circuit: 1. Push the nebulizer into the T-adapter , as shown in Figure 14. Figure 14. Assembling the Aerogen™* Pro Nebulizer

2.

Connect the nebulizer for each size as follows: •

For adult breathing circuits, connect the nebulizer unit with adult T-adapter into the inspiratory limb of the breathing circuit upstream of the patient wye (Figure 15). Figure 15. Connecting to an Adult Breathing Circuit

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3. Adult T-adapter