Instruction Manual
24 Pages
Preview
Page 1
Instruction Manual
Table of Contents Introduction... 1 Warnings... 2 Warranty... 6 Classifications and Markings... 7 Aeroneb Go Parts... 8 Assembly/Functional Test... 9 Operational Instructions... 10 Cleaning and storing... 12 Troubleshooting Guide... 15 Electromagnetic Susceptibility... 16 Specifications... 17 Performance... 18 Replacement Parts and Accessories... 19
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INTRODUCTION Be sure to read these instructions fully before use. Thank you for purchasing the Aeroneb® Go Nebulizer. Certain conditions such as asthma, COPD (chronic obstructive pulmonary disease) and cystic fibrosis require that prescribed liquid medication be turned into a fine mist, called an aerosol, and then inhaled into the lungs. The Aeroneb® Go turns liquid medication into an aerosol, which you can then inhale through a mouthpiece or an aerosol mask into your lungs. The Aeroneb® Go uses the unique OnQ™ Aerosol Generator, which is unlike any other nebulizer technology available. When you turn on your nebulizer, OnQ pumps liquid through tiny holes in a wafer-thin metal plate to create a soft mist aerosol. The Aeroneb® Go, for use by paediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer. Designed with your needs in mind, the Aeroneb® Go is portable, lightweight, compact and silent. The control module operates with three (3) “AA” disposable or rechargeable batteries (not included), or can alternatively be powered by the AC/DC adapter.
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IMPORTANT SAFEGUARDS When you use electrical products, always follow basic safety precautions. As with any electrical device take particular care around children. READ ALL WARNINGS AND INSTRUCTIONS BEFORE YOU USE YOUR NEBULIZER WARNING: If this product is being used to treat a life threatening condition, a backup device is necessary.
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•
As with any electronic device, this product may become unusable due to an electrical outage, battery depletion, or mechanical failure. We recommend that you have spare batteries and have a backup device available to you.
•
The AC/DC adapter does not charge batteries.
•
If you are using batteries and the green light is flashing, your batteries are low. You may finish your treatment and then change (or replace and recharge) the three “AA” batteries immediately.
•
Do not share your Aeroneb® Go Nebulizer with others. It is intended for use by a single user. If more than one person uses it, there is a risk of spreading infectious illness.
•
As with all electronic devices, it is recommended that it the product is unplugged when not in use.
•
Adult supervision is required when this product is used by children and individuals who require special assistance.
•
Use this product only for physician-prescribed solutions for inhalation as described in this manual.
WARNINGS CONTINUED: •
Do not use components or attachments that are not recommended by Aerogen. Refer to the Replacement Parts and Accessories section in this manual (page 18).
•
Never operate this product if any of the parts are not working properly or have been damaged.
•
Do not use the Aeroneb® Go Nebulizer in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide. As with any electrical equipment, take care when using the device in a potentially oxygen enriched environment.
•
Do not use the Aeroneb® Go Nebulizer with anaesthetic breathing systems or lung ventilator breathing systems.
•
Do not place or drop this product into water or any liquid when it is plugged into a power source.
•
Keep this product and cords away from heated surfaces.
•
Be sure the device has been properly cleaned before use to avoid possible contamination.
•
If after proper cleaning it takes longer than 12 minutes to deliver 3mL of normal saline (0.9%), the Nebulizer Unit should be replaced.
•
The user should ensure that exhaled medication is directed away from bystanders.
•
Do not microwave any parts.
•
By connecting the AC/DC adapter to the Aeroneb® Go Control Module, the Aeroneb® Go Control Module and batteries are not being charged.
•
As with any cables keep all cables tidy to avoid tripping or strangulation hazards and take particular care around children. 3
WARNINGS CONTINUED:
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•
Do not nebulize alcohol-based drugs in an oxygen-rich/ high pressure environment.
•
In event of loss of mains power, remove the AC/DC cable from the control module and operate with batteries (refer to page 9).
•
Never clean your Nebulizer Unit with solvents, chemicals, alcohol or abrasive cleaners.
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Do not use brushes, sharp tools or abrasive cloths that could scratch or damage the surfaces.
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Do not clean parts in a dishwasher.
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Store your Aeroneb® Go in the carrying case.
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Do not store the Aeroneb® Go in a location where it is exposed to direct sunlight, extreme heat or cold, dust or water. Store out of reach of children.
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Follow local laws and recycling plans regarding disposal or recycling of components, batteries and packaging.
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Before storing your Aeroneb® Go for an extended period, remove the batteries from the Aeroneb® Go Control Module and store them separately. If you do not take the batteries out, they may leak and cause your nebulizer to stop working.
WARRANTY The Aeroneb® Go Control Module and AC/DC Adapter are warranted for a period of two years from the date of purchase against defects in manufacturing. The Aeroneb® Go nebulizer unit is warranted for one year from date of purchase against defects in manufacturing. All warranties are based on typical usage. The life of the Aeroneb® Go nebulizer unit has been validated for use for 100 disinfecting treatments (boiling or baby bottle steam steriliser). This is based on a minimum of one year typical usage profile of 2 treatments per day and two disinfecting treatments per week. The user should note that any use in excess if this may result in reduced life of the product.
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CLASSIFICATIONS AND MARKINGS The symbols that appear on the Aeroneb® Go Nebulizer and its accessories are described in the table below: Symbol
Meaning Attention, consult accompanying documents Class II equipment per IEC 60601-1 Type BF equipment per IEC 60601-1. This label applies to Aeroneb® Go nebulizer unit only
US
Classified by TUV with respect to electric shock, fire and mechanical hazards
SN
Serial number
REF
Model number Manufacturer Input Output DC Voltage AC Voltage Power On/Off Fragile – Handle with care Keep Dry
+60 oC –20 C o
Storage temperature limits: -20°C to 60°C This device compiles with the requirements of the Medical Devices Directive (93/42/EEC) Consult Instructions for Use
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AERONEB® GO SYSTEM PARTS: Medication Cup Cap
Mouthpiece
Cable
Nebulizer body Base Control Module
AC/DC Adapter*
Mask Adapters
*Available with complete Aeroneb® Go System
UNIT ASSEMBLY AND USAGE NOTE: Clean all parts of your Aeroneb® Go Nebulizer (described on page 11) before first use, after each use, or after extended storage. PRIOR TO ASSEMBLY: Check all parts for visible damage. Replace any damaged parts before you use the Aeroneb® Go. In the case of missing parts, malfunction or damage, contact your local Aeroneb® Go representative or equipment supplier. 7
ASSEMBLY/FUNCTIONAL TEST
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1.
Connect the Medication Cup to the Nebulizer Body by lining up the notches on the medication cup and nebulizer body. NOTE: Make sure the Aeroneb® Go is unplugged before you add medication to the Medication Cup.
2.
Insert the nebulizer cable into the back of the nebulizer unit.
3.
Add Aeroneb® Go base to the bottom of the handset.
4.
Fill the Medication Cup with the prescribed nebulizer medication. Never pour more than 6 mL into the cup. The continuous line on the inside surface of the cup indicates the maximum filling level. CAUTION: To avoid damage to the nebulizer unit, do not use a syringe with needle.
5.
Place the Cap on Medication Cup.
6.
Attach Mouthpiece or Mask Connector and mask to Nebulizer Body.
HOW TO OPERATE THE AERONEB® GO NEBULIZER 1.
Turn the Aeroneb® Go Control Module upside down. Slide the battery cover in the direction of the arrow to remove the lid. Put in three (3) “AA” batteries (not included). Replace the cover on the Control Module and slide the cover until it locks in place. You can expect at least three (3) hours of operation from a new set of disposable batteries, (up to five (5) hours from high performance batteries).
2.
Connect the nebulizer cable to the Aeroneb® Go Control Module, indicated by the Output symbol ( ).
3.
Turn on the unit by pressing the “On/Off” button on the Control Module. You will see a green light on the Control Module light up.
4.
Visually verify that aerosol is coming out of the mouthpiece or mask to indicate that the device is functioning properly. NOTE: Do not cover the ventilation holes during use.
3 x AA LR6
3 x AA LR6
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5.
Alternatively, you can power the device by using the AC/DC Adapter if provided (refer page 7). Plug the AC/DC adaptor into a standard AC electrical outlet, a green light on the adapter indicates that the AC/DC adapter is turned on.
6.
Plug the AC/DC cable into the Control Module, indicated by the DC Voltage Symbol ( ). NOTE: the AC/DC adapter does not charge batteries.
7.
Place the mouthpiece between your teeth, with your lips firmly sealed around the mouthpiece. If you use an aerosol mask, place the mask over your mouth and nose. Breathe in and out slowly through your mouth until aerosol formation stops. Note: Aerosol mask is not provided. Do not cover ventilation holes.
8.
To turn off nebulizer, press the “On/Off” button on the Control Module.
9.
Visually verify that aerosol is coming out of the mouthpiece or mask to indicate that the device is functioning properly.
CLEANING AND STORING YOUR AERONEB® GO AFTER EVERY USE: Disconnect the control module before you take the nebulizer apart to rinse it. 1. Rinse the Nebulizer Unit (Medication Cup, Nebulizer Body, Base and Mouthpiece or Mask Adapter) under running hot tap water after every use. 2. Shake off excess water, and allow parts to fully air dry on a clean, dry towel, out of the reach of children. 3. Make certain that all cleaned parts are completely dry before you store or use them. DAILY: Disconnect the power source before you take the nebulizer apart to clean it. 1. Wash the Nebulizer Unit (Medication Cup and Cap, Nebulizer Body, Base and Mouthpiece or Mask Adapter) by hand in a solution of warm water and mild liquid dishwashing soap. Use soap intended only for washing dishes by hand. Do not use dishwasher detergent. Do not leave parts soaking. 2. Rinse all pieces thoroughly under running hot tap water. Make sure that no soap is left on any of the parts. 3. Shake off excess water, and allow parts to fully air dry on a clean, dry towel, out of the reach of children. 4. Make certain that all cleaned parts are completely dry before you store or use them.
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OPTIONAL DISINFECTION: If you would like to disinfect your Aeroneb® Go Nebulizer, you may use choose one of two options; Boiling or Vinegar Solution. 1.
BOILING: i.
ii. iii.
iv.
v.
vi.
Rinse the Nebulizer Unit (Medication Cup, Nebulizer Body, Base and Mouthpiece or Mask Adapter) under running hot tap water after every use. Shake off excess water, and allow parts to fully air dry on a clean, dry towel, out of the reach of children. Bring a saucepan of DISTILLED water to the boil and allow it to continue to boil. NOTE: Using regular tap water to boil the nebulizer unit will greatly reduce the life of the nebulizer unit. Carefully immerse the Nebulizer Unit in the boiling water. Leave the nebulizer immersed in the boiling water for a maximum of twenty (20) minutes. Carefully remove the nebulizer from the boiling water and shake off the excess water. Allow parts to fully air dry on a clean, dry towel, out of the reach of children. Make certain that all parts are completely dry before you store or use them.
Similarly, the Nebulizer Unit may be steam disinfected in a standard baby bottle steam sterilizer for fifteen (15) minutes. Refer to manufacturers instructions.
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OPTIONAL DISINFECTION (cont’d): 2.
VINEGAR SOLUTION: i.
ii. iii. iv.
v. vi. vii.
Rinse the Nebulizer Unit (Medication Cup, Nebulizer Body, Base and Mouthpiece or Mask Adapter) under running hot tap water after every use. Shake off excess water, and allow parts to fully air dry on a clean, dry towel, out of the reach of children. Fill a container with a mixture of three (3) parts hot water to one (1) part white distilled vinegar. Soak the Nebulizer Unit parts (Medication Cup and Cap, Nebulizer Body, and Mouthpiece or Mask Adapter) in the solution for thirty (30) minutes. Rinse all pieces thoroughly under running hot tap water. Shake off excess water, and allow parts to air dry on a clean, dry towel, out of the reach of children. Make certain that all disinfected parts are completely dry before you store or use them.
Cleaning of Control Module, Cable, AC/DC Adapter: Wipe with a clean cloth dampened with warm water and mild liquid detergent. •
Do not immerse in liquid.
•
Do not use abrasive or sharp tools.
•
Do not spray liquid directly onto the control module.
•
Do not immerse control module in liquid.
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TROUBLESHOOTING GUIDE If you have difficulty operating your Aeroneb® Go, check the following points: Problem
Check
Remedy
No visible aerosol when using batteries
Check that the batteries are inserted correctly.
Using the markings under each battery location, place each battery in the Control Module housing. Match (+) and (-).
Check to see if the low battery power light is flashing.
Replace the batteries or use the AC/DC Adapter.
Check that the Control Module cable is connected properly to the nebulizer and to the Control Module.
Connect the cable properly to the nebulizer and the Control Module (Refer to page 7).
Check that the AC/DC Adapter is plugged correctly into a working AC outlet and the green light is on the AC/DC Adapter.
Insert the plug into a working outlet and verify that the green light on the controller is lit (Refer to page 9).
Check that the AC/DC Adapter cable is connected properly to the Control Module.
Connect the AC/DC Adapter cable properly to the Control Module (Refer to page 9).
No visible aerosol when using AC/DC Adapter
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Problem
No visible aerosol when power source is functioning
Check
Remedy
Check that the AC/DC Adapter is not faulty.
Try to operate the Control Module by using batteries instead of the AC/DC Adapter. If the Control Module functions properly with batteries but not with the AC/DC adapter, replace the AC/DC Adapter.
Check that there is medication in the Medication Cup.
Fill the Medication Cup with prescribed medication.
Check that the nebulizer has been properly cleaned.
Clean the Aeroneb® Go. Refer to page 11.
If above remedies do not work, call your local supplier. ELECTROMAGNETIC SUSCEPTIBILITY This device meets the requirements of EN60601‑1‑2 which describes requirements for electromagnetic compatibility (EMC) of medical devices. 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.
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SPECIFICATIONS POWER SOURCES: Aeroneb® Go Control Module: 4.5 VDC (3 “AA” disposable or rechargeable batteries), 350 mA AC/DC Adapter: 100-240 VAC, 200 mA, 50-60 Hz POWER CONSUMPTION: Less than 2 watts APPROXIMATE WEIGHT: Aeroneb® Go Nebulizer Unit: 60g Aeroneb® Go Control Module with batteries: 260g AC Powered Controller: 180g AC/DC Adapter: 100g SOUND LEVEL: <35 dBA at 1 meter APPROXIMATE DIMENSIONS: Aeroneb® Go Nebulizer Unit (assembled): 40.0 x 105.0 x 95.0 mm Aeroneb® Go Control Module: 70.0 x 110.0 x 32.0 mm AC/DC Adapter: 74 (H) x 72 (D) x 49 (L) mm RECOMMENDED OPERATING ENVIRONMENT: Temperature range: 5°C to +45°C (+41°F to +113°F) Atmospheric pressure: 450 to 1100 mBars Humidity: up to 95% relative humidity RECOMMENDED TRANSPORT AND STORAGE ENVIRONMENT Temperature range: -20°C to +60°C (-4°F to +140°F) Atmospheric pressure: 450 to 1100 mBars Humidity: up to 95% relative humidity
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PERFORMANCE: Aerosol flow rate: Greater than 0.3 mL per minute Average tested flow rate: 0.4 mL per minute Residual Volume: <0.1 mL for a 3 ml dose Aerosol output rate: 0.25 mg per minute (salbutamol) Aerosol Output: 0.86 mL Average particle size: 3.5 microns mass median aerodynamic diameter Medication Cup capacity: Maximum of 6 mL The temperature of the medication will not rise more than 10°C (50°F) above ambient temperature during normal use. Performance may vary depending on the type of drug and nebulizer unit used. For additional information contact Aerogen or your drug supplier. Representative particle size distribution graph for albuterol as per EN13544-1 is shown below:
Cumulative Mass (%)
100.0
50.0
0.0 0.1
1
10
100
Aerodynamic Size (µm)
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