Aeroneb Pro Micro Pump Nebulizer Instruction Manual Rev H 2006

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Aeroneb Professional Nebulizer System

Instruction Manual

Table of contents Introduction ... 1 System description ...2 Warnings...4 Cautions...5 Electromagnetic susceptibility ...6 Symbols ...7 Controls and indicators ...9 Warranty ... 11 Life of Product ... 11 Assembly and Installation ... 12 Recharging the Battery ... 14 Installation for use with a ventilator ... 15 Installation for use with a mask ... 19 Installation for use with a mouthpiece ... 21 Adding medication ... 22 Nebulization ... 24 Functional test ... 26 Cleaning, disinfection and sterilization ... 27 Troubleshooting... 32 Order numbers ... 35 Specifications ... 37 Physical... 37 Environmental ... 37 Performance... 39 Power... 39

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Aeroneb Professional Nebulizer System Instruction Manual

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List of Figures ®

Figure 1: Aeroneb Pro... 2 ® Table 1: Aeroneb Pro symbols ... 7 ® Figure 2: Aeroneb Pro controls and indicators ... 9 Table 2: Aeroneb® Pro controls and indicators ... 10 Figure 3: Connecting nebulizer unit to T-adapter... 12 Figure 4: Connecting control module and nebulizer unit ... 13 Figure 5: Connecting the AC/DC adapter ... 14 Figure 6: Connecting to an adult breathing circuit... 16 Figure 7: Connecting to a pediatric breathing circuit ... 16 Figure 8: Connecting to a neonatal breathing circuit... 16 Figure 9: Alternative neonatal breathing circuit using neonate T-piece AG-AP1035 ... 17 Figure 10: Control module and universal mounting bracket (vertical)... 17 Figure 12: Equipment mount adapter ... 18 Figure 13: Connecting to a mask ... 20 Figure 14: Connecting to a mouthpiece... 21 Figure 15: Filling the nebulizer unit with a pre-filled ampoule ... 22 Figure 16: Maximum fill indication point... 23 Figure 17: Starting and stopping nebulization... 25 Table 3: Aeroneb® Pro troubleshooting ... 32 ® Table 4: Aeroneb Pro parts list ... 35

List of Tables Table 1: Aeroneb® Pro symbols ... 7 Table 2: Aeroneb® Pro controls and indicators ... 10 Table 3: Aeroneb® Pro troubleshooting ... 32 Table 4: Aeroneb® Pro parts list ... 35

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Aeroneb Professional Nebulizer System Instruction Manual

Introduction ®

The Aeroneb Professional Nebulizer 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. Aeroneb® Pro is suitable for use by neonate, pediatric to adult patients as described in this manual. It is a latex-free medical device for continuous nebulization that incorporates the Aerogen® OnQTM Aerosol Generator. Aeroneb® Pro is designed to operate in-line with standard ventilator circuits and mechanical ventilators in acute and subacute care environments. It operates without changing patient ventilator parameters and can be refilled without interrupting ventilation. The control module operates from the AC/DC adapter and can be operated on its internal rechargeable battery for up to 45 minutes. The product operates without compressed gas, making it suitable for portable applications.

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Aeroneb Professional Nebulizer System Instruction Manual

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System description ®

The Aeroneb Professional Nebulizer System (Figure 1) includes the following components: nebulizer unit (Aerosol Generator and filler cap), T-adapter (adult) with plug, control module, control module cable, AC/DC adapter, and mounting brackets. T-adapter plug

Filler Cap

1. Nebulizer unit with filler cap

2. T-adapter (adult) with plug

3. Control module

4. Control Module Cable

5. AC/DC adapter

6. Universal mounting bracket

7. Equipment mount adapter ®

Figure 1: Aeroneb Pro 2

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Aeroneb Professional Nebulizer System Instruction Manual

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The nebulizer unit holds up to 10 mL of liquid medication. The nebulizer unit is translucent to allow visual monitoring of 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 loss of circuit pressure. Within the nebulizer unit is an OnQTM 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-adapter securely connects the nebulizer unit into the breathing circuit and can be easily removed for cleaning. The T-adapter connections are standard male and female 22 mm ISO conical ports and connect to standard patient breathing circuits.

3,4,5.

The control module can operate from the AC/DC adapter or the internal rechargeable battery. The control module includes an on/off power button and sockets for the control module cable and the AC/DC adapter. The control module also includes indicators for nebulization cycle selection (15 or 30 minutes), battery charge status and fault conditions.

6.

A universal mounting bracket clamps the control module to standard IV poles and medical rail systems.

7.

An equipment mount adapter mounts the control module on standard equipment mounts.

Pediatric T-adapter, neonate adapters, mask adapter kits, elbow connectors and mouthpiece are sold separately.

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Warnings ®

Read and study all instructions before using Aeroneb Pro. Only medical personnel should operate the device. Do not leave patients unattended during nebulizer operation. 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 according to the instructions in this manual before first use and between patients. Do not place the control module 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 a flammable anesthetic mixture combined with air or with oxygen or nitrous oxide. Do not use to aerosolize alcohol-based medications, which can ignite in oxygen-enriched air under high pressure. To avoid the risk of fire, do not use in the presence of flammable substances.

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Aeroneb Professional Nebulizer System Instruction Manual

Cautions To avoid damage to the nebulizer: •

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 unit 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 OnQTM Aerosol Generator.

•

Do not use a syringe with a needle to add medication.

•

Do not use abrasive or sharp tools to clean the nebulizer unit.

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 Aeroneb® Pro nebulizer system sales representative. Disconnect nebulizer unit from control module before cleaning. Do not immerse or autoclave the control module 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 unit or the control module.

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Do not use in the presence of devices generating high electromagnetic fields such as magnetic resonance imaging (MRI) equipment. ®

The Aeroneb Pro control module 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.

Electromagnetic susceptibility This device meets the requirements of the Electromagnetic Compatibility (EMC), pursuant to the Collateral Standard, EN 60601-1-2 (second edition), which addresses EMC in North America, Europe and other global communities. This includes immunity to radio frequency electric fields and electrostatic discharge, in addition to the other applicable requirements of the standard. Compliance with EMC standards does not mean a device has total immunity; certain devices (cellular phones, pagers, etc.) can interrupt operation if they are used near medical equipment. Follow institutional protocol regarding the use and location of devices that could interfere with medical equipment operation. Note: This device is classified as Class II Type BF medical electrical equipment and the device complies with specified safety levels for electrical isolation and leakage current. The Aeroneb Pro AC/DC adapter has no connection to earth ground because the necessary level of protection is achieved through the use of double insulation.

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Aeroneb Professional Nebulizer System Instruction Manual

Symbols ®

The following symbols apply to Aeroneb Pro and appear on the back of the control module and on the packaging: ®

Table 1: Aeroneb Pro symbols Symbol AP-YYXXXX

Meaning Serial number, where YY is the year of manufacture and XXXX is the serial number. Attention, consult accompanying documents.

Degree of protection against dripping water.

Class II equipment per IEC 60601-1.

Type BF equipment per IEC 60601-1.

On/off power button (standby). Timer selection (to select the 15 minute or 30 minute nebulization cycles) Control Module Input – DC voltage.

~

Control Module Output – AC voltage.

Output

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Aeroneb Professional Nebulizer System Instruction Manual

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Table 1: Aeroneb® Pro symbols Symbol

Meaning Components are latex free

Battery status indicator.

Fragile, handle with care. Storage temperature limitations –20 °C to +60 °C. Keep dry.

Rx Only

1RD4

0050

Federal (US) law restricts this device to sale by or on the order of a physician. Classified by Underwriters Laboratories Inc. with respect to electric shock, fire and mechanical hazards only in accordance with UL 2601-1 (1RD4) and with respect to electric shock, fire, mechanical and other specified hazards only in accordance with CAN/CSA C22.2 No. 601.1, Medical equipment certified for Canada (1RD4). This device complies with the requirements of the Medical Devices Directive (93/42/EEC). Separate collection required for waste electrical and electronic equipment.

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Aeroneb Professional Nebulizer System Instruction Manual

Controls and indicators

On/Off Power Fault Indicator Timer Selection

30 Min. Indicator Battery Status Indicator 15 Min. Indicator 9V D.C. Input

Control Module Cable Input

Figure 2: Aeroneb® Pro controls and indicators

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Aeroneb Professional Nebulizer System Instruction Manual

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Table 2: Aeroneb Pro controls and indicators Control/indicator

Function

15 Min. indicator

Green (steadily lit) = 15 minute nebulization cycle on
Green (flashing) = Low battery power
Nebulizer unit automatically powers off after 15 minutes have elapsed

30 Min. indicator

Green (steadily lit) = 30 minute nebulization cycle on
Green (flashing) = Low battery power
Nebulizer unit automatically powers off after 30 minutes have elapsed

Fault indicator

Amber = Faulty electrical connection

On/off power button

Pressing and immediately releasing selects the 15 minute nebulization cycle
Pressing and holding for at least three seconds selects the 30 minute nebulization cycle
Pressing during nebulization turns off power to the nebulizer

Battery status indicator

Green = Battery fully charged
Amber = Battery charging
No light = Battery in operation

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Aeroneb Professional Nebulizer System Instruction Manual

Warranty The Aeroneb® Pro nebulizer unit is warranted for one year from date of purchase against defects in manufacturing. The Aeroneb® Pro Control Module and AC/DC Adapter are warranted for a period of two years from the date of purchase against defects in manufacturing. All warranties are based on typical usage.

Life of Product As with all active electronic components, the Aeroneb® Pro nebulizer unit has a defined life. In the case of Aeroneb® Pro, the life of the nebulizer unit has been validated for use for a minimum of one year based upon a typical usage profile of 4 treatments per day and one sterilization per week where the device is assumed to be in service for 50% of the time. The user should note that use in excess of this pattern may result in reduced life of the product.

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Assembly and Installation 1. Clean and sterilize the nebulizer unit and T-adapter(s) as described in the Cleaning, disinfection and sterilization section of this manual. Note: The nebulizer unit and T-adapter, as packaged, are not sterile. 2. Perform a functional test of Aeroneb® Pro before use and between patients as described in the functional test section of this manual. 3. Insert the filler cap into the opening on the nebulizer unit. 4. Connect the nebulizer unit to the T-adapter by pushing the nebulizer unit firmly onto the T-adapter (Figure 3).

Figure 3: Connecting nebulizer unit to T-adapter

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Aeroneb Professional Nebulizer System Instruction Manual

5. Connect the control module and the nebulizer unit together using the control module cable (Figure 4).

Figure 4: Connecting control module and nebulizer unit 6. To operate on AC power (the primary mode of operation), insert the AC/DC adapter connector into the control module and plug the adapter into an AC power source (Figure 7). 7. Aeroneb® Pro can be battery-operated for portable applications. The rechargeable battery can power the System for up to 45 minutes. In the case of AC power failure the control module 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 Aeroneb® Pro, secure both the AC/DC adapter cable and the control module 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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Figure 5: Connecting the AC/DC adapter

Recharging the Battery To recharge the battery, connect the AC/DC adapter to the control module and AC power (Figure 5). The battery status indicator is amber while charging and green when fully charged. Allow a minimum of four hours for the internal battery to fully recharge. Note: If the control module is placed in long-term storage, it is recommended that the battery be recharged every 3 months.

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Aeroneb Professional Nebulizer System Instruction Manual

Installation for use with a ventilator 1. For adult breathing circuits, connect the nebulizer unit with adult T-adapter into the inspiratory limb of the breathing circuit before the patient wye (Figure 6). For pediatric breathing circuits, connect the nebulizer unit with pediatric T-adapter into the inspiratory limb of the breathing circuit before the patient wye (Figure 7). For neonatal breathing circuits, connect the nebulizer unit with the pediatric T-adapter and the neonate adapters approximately 30cm (12 in.) back from the patient wye (Figure 8). Or alternatively connect the nebulizer with the Neonate T-adapter either at the patient wye or 30cm (12 in.) back from the patient wye (figure 9). WARNING:
Always maintain the nebulizer in a vertical orientation (with the filler cap uppermost) while in the patient circuit (Figures 6, 7 and 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 OnQTM Aerosol Generator.

When removing the nebulizer unit from the patient circuit always replace the T-adapter plug to maintain circuit pressure.

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.

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Wye

ADULT

From ventilator

Adult T-adapter

Figure 6: Connecting to an adult breathing circuit

PEDIATRIC

Wye

From ventilator Pediatric T-adapter

Figure 7: Connecting to a pediatric breathing circuit

Neonate adapters Wye

NEONATE

From ventilator Pediatric T-adapter

Figure 8: Connecting to a neonatal breathing circuit

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Aeroneb Professional Nebulizer System Instruction Manual