Aerogen Aerogen USB Controller Page 6 Instruction Manual Download

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Aerogen

The Aerogen USB Controller can be used with Aerogen nebulizers as
follows:

Table 1.

Intended Use Summary

Aerogen Solo

Nebulizer

Aerogen Pro

Nebulizer

Hospital - Ventilated patients

Hospital -Spontaneously Breathing Patients

30 Minute Mode Operation

6 Hour Mode Operation

Summary of Contents for Aerogen USB Controller

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

Page 2: ......

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 71: ......

Page 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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