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Aerogen

USB Controller System Instruction Manual

Introduction

The Aerogen

USB Controller System is:

• A portable medical device that is intended to aerosolize physician-

prescribed medications for inhalation.

• The Aerogen

USB Controller should only be operated from mains

using the Aerogen USB Controller AC/DC Adapter.

• An alternative to the existing Aerogen

Pro and Aerogen

Pro-X

Controllers.

Indications for Use

The Aerogen

USB Controller System includes the Aerogen

Pro and

Aerogen

Solo Nebulizers, which are intended to aerosolize physician-

prescribed medications for inhalation to patients on and off ventilation or
other positive pressure breathing assistance in the hospital environment,
and on vent only in the homecare environment.

The Aerogen

Pro Nebulizer is intended for

multiple patient use in

hospital environment

and

single patient use in home environment

Aerogen

Solo Nebulizer is for

single patient use

. Both nebulizers are for

pediatric (29 days or older) and adult patients.

Содержание Aerogen USB Controller

Страница 1: ...Hospital Use page 1 Home Use page 38 for use with Aerogen Solo and Aerogen Pro System Instruction Manual www aerogen com...

Страница 2: ......

Страница 3: ...Aerogen USB Controller System Instruction Manual 1 Aerogen USB Controller System Instruction Manual for use with Aerogen Solo and Aerogen Pro HOSPITAL USE...

Страница 4: ...Accessories 14 Functional Test 23 Aerogen Solo Aerosol Flow Rate Calculation 24 Cleaning of the Aerogen USB Controller System 25 Troubleshooting 30 Warranty 31 Life Of Products 31 Specifications 32 Ae...

Страница 5: ...dications for Use The Aerogen USB Controller System includes the Aerogen Pro and Aerogen Solo Nebulizers which are intended to aerosolize physician prescribed medications for inhalation to patients on...

Страница 6: ...with Aerogen nebulizers as follows Table 1 Intended Use Summary Intended Use Summary Aerogen Solo Nebulizer Aerogen Pro Nebulizer Hospital Ventilated patients Hospital Spontaneously Breathing Patient...

Страница 7: ...Multiple patient use 2 Aerogen Solo Nebulizer Single patient use Aerogen Pro Nebulizer Multiple patient use 3 Aerogen Solo T Piece Silicone Plug Single patient use Aerogen Pro T Piece Silicone Plug Mu...

Страница 8: ...the Functional Test section of this manual see page 23 Connect the Aerogen Solo or Aerogen Pro nebulizer by firmly pushing into the T piece Connect the Aerogen USB Controller to the nebulizer as show...

Страница 9: ...dry side of the humidifier Connect the Aerogen USB Controller to the Aerogen USB Controller AC DC Adapter Open the plug on the nebulizer and use a pre filled ampoule or syringe to add medication to t...

Страница 10: ...ode press the On Off button from the off mode for 3 seconds Note Verify the correct mode of operation is selected Verify that aerosol is visible Note Clips are provided to assist with cable management...

Страница 11: ...devices whose manufacturer s instructions allow use with a nebulizer and always follow the HME manufacturer s instructions Ensure that the total combined volume of nebulizer T piece and HME is suitab...

Страница 12: ...ned with air 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 equipme...

Страница 13: ...t attempt to clean the device while in use Do not obstruct the removal of the Aerogen USB Controller AC DC Adapter from the mains Do not store the Aerogen USB Controller System in a location where it...

Страница 14: ...Palladium Vibrating Mesh Technology Aerogen Vibronic Use of the Aerogen Solo and T piece during the administration of volatile anesthetics may result in adverse effects on the constituent plastics Do...

Страница 15: ...cycle on Amber Nebulizer disconnect Aerogen USB Controller automatically powers off after 6 hours have elapsed Error Indicator 30 Minute and 6 Hour Indicators flash amber alternatively twice Internal...

Страница 16: ...Circuit Connect the nebulizer to 10mm pediatric breathing circuits with the 15mm pediatric T piece and the pediatric adapters This can be positioned approximately 30 cm 12 in back from the patient Y...

Страница 17: ...for use with a nebulizer should be used in this configuration as shown Follow the HME manufacturer instructions regarding use with a nebulizer Ensure the combination of nebulizer T piece and HME volum...

Страница 18: ...ing the parts together Rotate the vented elbow to suit the position of the patient Mouthpiece When using a standard ISO 22 mm mouthpiece connect the nebulizer to the T piece as shown and connect the T...

Страница 19: ...nts via a mouthpiece or aerosol face mask If supplemental oxygen is used for pediatric patients under 18 years of age a maximum flow rate of 2 LPM should be used Note The mouthpiece should not be used...

Страница 20: ...rosol face mask is required remove mouthpiece and attach the aerosol face mask to Aerogen Ultra Note When using an aerosol face mask a minimum oxygen flow of 1 LPM is required 4 Add medication to Aero...

Страница 21: ...re oxygen connection port or tubing is not occluded Do not use Aerogen Ultra without a mouthpiece or face mask Visually check Aerogen Ultra post rinsing to ensure that valves have not become dislodged...

Страница 22: ...is firmly fitted into the Aerogen Solo T piece in the breathing circuit 2 Remove the syringe cap from the medication filled syringe 3 Attach the syringe end of the tubing onto the syringe 4 Prime the...

Страница 23: ...hour is based on Aerogen s specification for the minimum nebulizer flow rate For directions on determining flow rates refer to the Optional Flow Rate Calculation method in the Functional Test section...

Страница 24: ...utput rate of the nebulizer A rising level of medication in the reservoir indicates that the fill rate is exceeding the output rate of the nebulizer Replace both the tube set and syringe when changing...

Страница 25: ...nd release the On Off power button and verify that the 30 Minute Mode indicator light is green and that aerosol is visible 5 Disconnect the nebulizer from the controller Verify that the amber Error In...

Страница 26: ...idual Aerogen Solo nebulizer follow these steps 1 Transfer 0 5 mL of normal saline 0 9 or intended drug into the Aerogen Solo medication cup 2 Turn on the nebulizer 3 Using a stop watch measure the le...

Страница 27: ...erilized Aerogen Pro See instructions below Aerogen USB Controller controller cables and Aerogen USB Controller AC DC Adapter 1 Wipe clean with an alcohol based disinfectant wipe or a quaternary ammon...

Страница 28: ...with sterile water 5 Shake excess water from parts and allow parts to fully air dry Cleaning is recommended to be carried out between treatments on the same patient Warning Do not use abrasive or sha...

Страница 29: ...f any other means of cleaning disinfection or sterilization has not been qualified and is likely to reduce the life of your nebulizer and will invalidate your warranty Sterilization of the Aerogen Pro...

Страница 30: ...ollowing cycle was validated without the use of a detergent Water Quality Mains water Method 1 Load the components in the automated washer 2 Wash components for 10 minutes at 91 C 195 8 F 3 Drain the...

Страница 31: ...ed cycle 3 Autoclave wrapped parts using steam sterilization pre vacuum cycle a minimum of 134 C 270 F 275 F for 20 minutes with drying cycle Note Sterilization using the autoclave cycle No 3 above ma...

Страница 32: ...our indicator lights amber The Aerogen USB Controller cable is incorrectly connected Verify the Aerogen USB Controller cable is correctly connected to the nebulizer Nebulizer used beyond life of produ...

Страница 33: ...r 1460 doses 4 treatments per day over a 1 year period The Aerogen Pro nebulizer and components have been qualified for 730 doses 4 doses per day 26 autoclave cycles 1 autoclave cycle per week where t...

Страница 34: ...cap Nebulizer Capacity Maximum 10 mL Table 7 Physical Specification of the Aerogen USB Controller Dimensions 2865mm L X 28mm W X 25 2mm H 112 8 in L X 1 1 in W X 1 in H Aerogen USB Controller Weight 9...

Страница 35: ...of the medication will not rise more than 10 C 18 F above ambient during normal use Table 10 shows the results of aerosol performance testing for the Aerogen Solo using an 8 stage cascade impactor run...

Страница 36: ...the Aerogen Solo and Aerogen Ultra Gas Flow Rate LPM Breathing Profile Patient Interface Mouthpiece Open Face Mask Valved Face Mask 0 Adult 73 5 61 6 N A 70 7 52 3 Pediatric 54 5 45 6 N A 52 9 42 5 2...

Страница 37: ...ade Impactor Specification Range 1 5 m Average Tested 3 1 m As per EN 13544 1 with a starting dose of 2 mL Aerosol Output rate 0 24 mL min Aerosol Output 1 08 mL emitted of 2 0 mL dose Residual Volume...

Страница 38: ...C EN 60601 1 2 Edition 3 2007 which addresses EMC in North America Europe and other global communities This includes immunity to radio frequency electric fields and electrostatic discharge in addition...

Страница 39: ...ion against foreign objects equal to or greater than 12 5mm in diameter and against drops of water falling at up to 15 from vertical Aerogen USB Controller Output AC voltage Class II equipment per IEC...

Страница 40: ...38 Aerogen Aerogen USB Controller System Instruction Manual for use with Aerogen Solo and Aerogen Pro HOME USE...

Страница 41: ...43 System Warnings 46 Controls Indicators 50 Accessories 51 Functional Test 52 Cleaning of the Aerogen USB Controller System 53 Troubleshooting 56 Warranty 57 Life Of Products 57 Specifications 58 Ae...

Страница 42: ...for Use The Aerogen USB Controller System includes the Aerogen Pro and Aerogen Solo Nebulizers which are intended to aerosolize physician prescribed medications for inhalation to patients on vent only...

Страница 43: ...41 The Aerogen USB Controller can be used with Aerogen nebulizers as follows Table 1 Intended Use Summary Intended Use Summary Aerogen Solo Nebulizer Aerogen Pro Nebulizer Homecare Ventilated patient...

Страница 44: ...se 2 Aerogen Solo Nebulizer Single patient use Aerogen Pro Nebulizer Single patient use 3 Aerogen Solo T Piece Silicone Plug Single patient use Aerogen Pro T Piece Silicone Plug Single patient use 4 C...

Страница 45: ...o use as described in the Functional Test section of this manual see page 52 Connect the Aerogen Solo or Aerogen Pro nebulizer by firmly pushing into the T piece Connect the Aerogen USB Controller to...

Страница 46: ...idifier Connect the Aerogen USB Controller to the Aerogen USB Controller AC DC Adapter Open the plug on the nebulizer and use a pre filled ampoule or syringe to add medication to the nebulizer Close t...

Страница 47: ...o operate in 6 Hour Mode press the On Off button from the off mode for 3 seconds Note Verify the correct mode of operation is selected Verify that aerosol is visible Note Clips are provided to assist...

Страница 48: ...with natural rubber latex Only use physician prescribed solutions that are approved for use with a general purpose nebulizer Consult drug manufacturer s instructions regarding suitability for nebuliza...

Страница 49: ...local laws and recycling plans regarding disposal or recycling of components and packaging Do not use the Aerogen USB Controller adjacent to or stacked with other equipment If adjacent or stacked use...

Страница 50: ...ld only be operated from the mains power supply Condensate can collect and occlude ventilator circuits Always position ventilator circuits so that fluid condensate drains away from the patient Adult s...

Страница 51: ...on the constituent plastics Do not use with volatile anesthetics unless known to be compatible Aerogen have determined that using anesthetic ventilators the following volatile anesthetic agents are co...

Страница 52: ...zer disconnect Aerogen USB Controller automatically powers off after 6 hours have elapsed Error Indicator 30 Minute and 6 Hour Indicators flash amber alternatively twice Internal error condition Aerog...

Страница 53: ...d the pediatric adapters This can be positioned approximately 30 cm 12 in back from the patient Y Dry Side of the Humidifier The Aerogen Solo can be placed on the dry side of the humidifier as shown T...

Страница 54: ...fy that the 30 Minute Mode indicator light is green and that aerosol is visible 5 Disconnect the nebulizer from the controller Verify that the amber Error Indicator lights Reconnect the nebulizer to t...

Страница 55: ...erogen Pro See instructions below Aerogen USB Controller controller cables and Aerogen USB Controller AC DC Adapter 1 Wipe clean with an alcohol based disinfectant wipe or a quaternary ammonium compou...

Страница 56: ...ing is recommended to be carried out between treatments on the same patient Warning Do not use abrasive or sharp tools to clean the nebulizer unit Boiling the Aerogen Pro Accessories 1 Rinse the Aerog...

Страница 57: ...e excess water Allow parts to fully air dry on a clean dry towel out of the reach of children 6 Make certain that all parts are completely dry before you store or use them Warning The use of any other...

Страница 58: ...our indicator lights amber The Aerogen USB Controller cable is incorrectly connected Verify the Aerogen USB Controller cable is correctly connected to the nebulizer Nebulizer used beyond life of produ...

Страница 59: ...The Aerogen USB Controller has been qualified for use for 1460 doses 4 treatments per day over a 1 year period The Aerogen Pro nebulizer and components have been qualified for 730 doses 4 doses per da...

Страница 60: ...mum 10 mL Table 7 Physical Specification of the Aerogen USB Controller Dimensions 2865mm L X 28mm W X 25 2mm H 112 8 in L X 1 1 in W X 1 in H Aerogen USB Controller Weight 91g 3 2 oz Table 8 Environme...

Страница 61: ...n or drug supplier The temperature of the medication will not rise more than 10 C 18 F above ambient during normal use Table 10 shows the results of aerosol performance testing for the Aerogen Solo us...

Страница 62: ...rogen Pro nebulizer as the fundamental scientific technology in both nebulizers is the same Table 11 Performance Specifications of the Aerogen Pro Flow Rate 0 2 mL min Average 0 4 mL min Particle Size...

Страница 63: ...Controller System Instruction Manual 61 Representative particle size distribution for Albuterol as per EN 13544 1 is shown below for the Aerogen Pro 0 20 40 60 80 100 0 1 1 10 Particle Size m Cumulati...

Страница 64: ...C EN 60601 1 2 Edition 3 2007 which addresses EMC in North America Europe and other global communities This includes immunity to radio frequency electric fields and electrostatic discharge in addition...

Страница 65: ...ion against foreign objects equal to or greater than 12 5mm in diameter and against drops of water falling at up to 15 from vertical Aerogen USB Controller Output AC voltage Class II equipment per IEC...

Страница 66: ...etic Environment Guidance RF Emissions CISPR 11 Group 1 The Aerogen USB Controller System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to ca...

Страница 67: ...cations equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 3...

Страница 68: ...t Surge IEC EN 61000 4 5 1 kV line s to line s 2 kV Line s to earth 1 kV line s to line s 2 kV Line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltag...

Страница 69: ...om fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked w...

Страница 70: ...68 Aerogen This page has been intentionally left blank...

Страница 71: ......

Страница 72: ...2017 Aerogen Ltd Part No AG UC1050 US P N 30 914 Rev D 886 423 7643 info aerogen com www aerogen com twitter com aerogen US e w Manufacturer Galway Business Park Dangan Galway Ireland Aerogen Ltd...

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