Aeroneb Solo Instruction Manual Rev J 2011

Aeroneb Solo System ®

Instruction Manual

Part Number: AG-AS3050-EN Rev. J © 2011 Aerogen Ltd.

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Table of contents Introduction System description Warnings Electromagnetic susceptibility Symbols Controls and indicators Warranty Life of Product Assembly and Installation

1 2 5 7 9 11 13 13 14

Recharging the Battery 21 Installation for use with a ventilator 21 Installation for use with a mask...25 Installation for use with a mouthpiece...26 Adding medication 27 Nebulization

28

Functional test

30

Cleaning of Pro-X Control Module

32

Troubleshooting

33

Order numbers

36

Specifications

38

Physical Environmental Performance Power Appendix 1 EMC tables

38 38 39 39 41

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List of Figures Figure 1: Figure 2: Figure 3: Figure 4: Figure 5: Figure 6:

Aeroneb® Solo System 2 Aeroneb® Pro-X controls and indicators 11 Connecting nebulizer unit to T-piece 14 Connecting control module and nebulizer unit 15 ® Connecting the Aeroneb Pro-X AC/DC adapter 15 Connecting tubing and syringe to the Aeroneb® Solo for continuous nebulization 18 Figure 7: Connecting to an adult breathing circuit 22 Figure 8: Connecting to a pediatric breathing circuit 22 Figure 9: Connecting to a neonate breathing circuit 22 Figure 10: Alternative neonatal breathing circuit using neonate T-piece 23 Figure 11: Control module and universal mounting bracket (Vertical) 24 Figure 12: Control module and universal mounting bracket (Horizontal) 24 Figure 13: Equipment mount adapter 24 Figure 14: Connecting to a mask...25 Figure 15: Connecting to a mouthpiece...26 Figure 16: Filling the nebulizer unit with a pre-filled ampoule 27 Figure 17: Starting and stopping nebulization 29

List of Tables Table 1: Aeroneb® Solo system symbols Table 2: Aeroneb® Pro-X controls and indicators Table 3: Aeroneb® Pro-X troubleshooting Table 4: Aeroneb® Solo Parts List

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Aeroneb® Solo System Instruction Manual

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, which consists of the Aeroneb® Solo nebulizer and the Aeroneb® Pro-X controller, is a nebulizer system designed for use with mechanically ventilated patients to aerosolize 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 use with neonate, pediatric and adult patients as described in this manual. It is for intermittent and continuous nebulization that incorporates Aerogen’s OnQ™ Aerosol Generator. The Aeroneb® Solo nebulizer 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 Aeroneb® Pro-X control module 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 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. Aeroneb® Solo System Instruction Manual

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System description The Aeroneb® Solo System (Figure 1) includes the following components: nebulizer unit (aerosol generator and plug), T-piece (adult)*, Aeroneb® Pro-X control module, control cable, AC/DC adapter and mounting brackets. (Pedatric & neonate adapters and continuous nebulization tube set are sold separately).

1. Nebulizer unit with plug

2. T-piece (Adult)*

!

On/Off

Timer 30 Min. Continuo us Mode

ml

60

8. Equipment mount adapter

50

7. Universal mounting bracket

40

6. Continuous Nebulization Tube Set

30

5. AC/DC adapter

10

4. Control Module Cable

20

3. Control module

Figure 1: Aeroneb® Solo System 2

Aeroneb® Solo System Instruction Manual

1.

The nebulizer unit holds up to 6mL of liquid medication. The nebulizer unit is clear to allow visual monitoring of medication levels and aerosolization. When the nebulizer unit is connected into the ventilator circuit, the silicone plug can be opened and closed in between doses without causing loss of circuit pressure. Within the nebulizer unit is an OnQ™ 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 unit into the breathing circuit. The T-piece connections are standard male and female 22mm conical ports and connect to standard patient breathing circuits. Aerogen recommends that the Aeroneb® Solo nebulizer be used in conjunction with a relevant disposable T-piece supplied by Aerogen.

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 (30 minutes or continuous), battery charge status and fault conditions. 6.

The Aeroneb® Solo can be operated continuously by attaching the continuous nebulization tube set accessory. The continuous nebulization tube set is designed for use with a syringe pump for continuous drug dosing.

Aeroneb® Solo System Instruction Manual

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7.

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

8.

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

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Aeroneb® Solo System Instruction Manual

Warnings Read and study all instructions before using the Aeroneb® Solo system. Only medical personnel should operate the device. Perform functional test prior to use to ensure correct operation (see page 30). This is a single patient use device not to be used on more than one patient to prevent cross infection. Do not use beyond defined life (see page 13). During use observe for correct functioning of the nebulizer. The nebulizer unit and T-piece, as packaged, are not sterile. Do not autoclave the Aeroneb® Solo nebulizer. The continuous mode can only be operated from the mains supply and cannot be operated by battery power. 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. Do not use a filter or heat-moisture exchanger (HME) between the nebulizer and patient airway. Do not wrap the nebulizer cable tightly around any of the system components. 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. Only use physician-prescribed solutions that are approved for use with a general purpose nebulizer. To ensure optimum drug administration, consult the drug manufacturer’s instructions regarding suitability for nebulization. Aeroneb® Solo System Instruction Manual

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Warnings Do not use in the presence of a flammable anesthetic mixture combined with air or with 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 nebuliser or T-piece plastics. 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. 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 OnQ™ 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.

Do not use the Aeroneb® Solo nebulizer with the reusable connectors available with the Aeroneb® Pro nebulizer. Aerogen recommend use of the relevant disposable T-pieces and adapters provided by Aerogen with the Aeroneb® Solo nebulizer. 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 Aerogen product sales representative. Do not immerse or autoclave the control module or AC/DC adapter. 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. 6

Aeroneb® Solo System Instruction Manual

Warnings Do not use in the presence of devices generating high electromagnetic fields such as magnetic resonance imaging (MRI) equipment. The Aeroneb® Pro-X 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. Follow local laws and recycling plans regarding disposal or recycling of components, batteries and packaging. The Aeroneb® Solo nebulizer is designed for use in continuous mode only when used with the Aeroneb® Pro –X controller. Do Not use the Aeroneb® Pro Nebulizer in continuous mode. Caution: Federal law restricts this device to sale by or on the order of a physician

Electromagnetic susceptibility This device meets the requirements of the Electromagnetic Compatibility (EMC), pursuant to the Collateral Standard, IEC/EN 60601-1-2, 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® Solo AC/DC adapter (AG-AP1040-XX) has no connection to earth ground because the necessary level of protection is achieved through the use of double insulation. Aeroneb® Solo System Instruction Manual

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Warnings •

Only use the Aeroneb® Solo nebulizer with components specified in the Instructions for Use. Use of the Aeroneb® Solo nebulizer with components other than those specified in the Instructions for Use may result in increased emissions or decreased immunity of the Aeroneb® Solo nebulizer system.

•

Do not use the Aeroneb® Solo adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in this configuration.

•

The Aeroneb® Solo needs special precautions regarding electromagnetic compatibility (“EMC”) and must be installed and put into service according to the EMC information provided in the Instructions for Use.

•

Portable and mobile radio frequency (“RF”) communication devices can disrupt medical electrical equipment.

Refer to Appendix 1 for EMC Tables as per IEC/EN 60601-1-2

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Aeroneb® Solo System Instruction Manual

Symbols The following symbols apply to Aeroneb® Solo nebulizer and Aeroneb® Pro-X controller. These symbols appear on the back of the control module and on the packaging: Table 1: Aeroneb® Solo System 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/EN 60601-1 Type BF equipment per IEC/EN 60601-1

30 (Min.)

30 minute operating mode

8

On/Off power button (standby)

Continuous operating mode (International) Control Module Input – DC voltage Control Module Output – AC voltage Does not contain natural rubber latex Output Battery status indicator Fragile, handle with care

Aeroneb® Solo System Instruction Manual

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Table 1: Aeroneb® Solo System Symbols Symbol +60 oC

–20 oC

Meaning Transient storage temperature limitations –20 °C to +60 °C. Keep dry.

Rx Only

US

Federal (US) law restricts this device to sale by or on the order of a physician. Classified by TUV with respect to electric shock, fire and mechanical hazards. This device complies with the requirements of the Medical Devices Directive (93/42/EEC).

NON STERILE

Non-Sterile Consult Instructions for Use Use by (YYYY-MM) Manufacturer Batch Code

SN

Serial Number

REF

Catalogue Number Single Patient Use, Do not reuse

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Aeroneb® Solo System Instruction Manual

Controls and indicators North American Controller On/Off Power Fault Indicator !

On/Off Timer

30 Min. Indicator 30 Min.

Continuous Mode Indicator

Continuo

us Mode

Timer Selection Battery Status Indicator

9V D.C. Input

Control Module Cable Input

International Controller On/Off Power

Fault Indicator !

Continuous Mode Indicator

On/Off Timer 30

8

30 Min. Indicator

Timer Selection Battery Status Indicator

9V D.C. Input

Control Module Cable Input

Figure 2: Aeroneb® Pro-X controls and indicators Aeroneb® Solo System Instruction Manual

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Table 2: Aeroneb® Pro-X controls and indicators Control/indicator

Function

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

Continuous indicator

Green (steadily lit) = Continuous nebulization cycle on Nebulizer unit 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

Pressing and immediately releasing selects the 30 minute nebulization cycle Pressing and holding for at least three seconds selects the continuous 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® Solo System Instruction Manual

Warranty Aerogen warrants that the Aeroneb® Solo nebulizer shall be free from defects of workmanship and materials for a period of the defined life of the nebulizer when used in accordance with this instruction manual. The Aeroneb® Pro-X Control Module and AC/DC Adapter are warranted against defects in manufacturing for a period of two years from the date of purchase. All warranties are based on typical usage, detailed below.

Life of Product As with all active electronic components, the Aeroneb® Solo nebulizer unit has a defined life. In the case of Aeroneb® Solo, the life of the nebulizer unit has been validated for intermittent use for a maximum of 28 days based upon a typical usage profile of 4 treatments per day. For continuous use the life of the Aeroneb® Solo nebulizer unit and the continuous nebulization tube set have been validated for use for a maximum of 7 days. The user should note that use in excess of these periods is not validated by Aerogen.

Aeroneb® Solo System Instruction Manual

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Assembly and Installation Intermittent Nebulization Perform a functional test of the Aeroneb® Solo before use as described in the Functional Test section of this manual (See page 30). 1.

Connect the nebulizer unit to the T-piece by pushing the nebulizer unit firmly onto the T-piece (Figure 3).

Figure 3: Connecting nebulizer unit to T-piece 2.

Insert the nebulizer 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.

3.

Connect the Aeroneb® Pro-X control module to the Aeroneb® Solo nebulizer unit using the nebulizer cable as shown in Figure 4.

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Aeroneb® Solo System Instruction Manual

!

8

30

Figure 4: Connecting control module and nebulizer unit 4.

Connect the Aeroneb® Pro-X AC/DC adapter to the Aeroneb® Pro-X controller as shown in Figure 5.

!

8

30

Figure 5: Connecting the Aeroneb® Pro-X AC/DC adapter Aeroneb® Solo System Instruction Manual

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