Aeroneb® Solo Instruction Manual USA
Contents
1. Aerogen wm Aeroneb Solo System Instruction Manual Aeroneb Solo System Instruction Manual Introduction System Warnings Assembly amp Installation Installation For Use With A Ventilator Installation For Use Off Ventilator Nebulization Modes Aeroneb Solo Aerosol Flow Rate Calculation Troubleshooting Parts List Warranty Life Of Product Specifications Performance Symbols Appendix 1 Appendix 1 EMC Tables Aeroneb Solo System Instruction Manual 10 12 15 19 20 22 24 24 25 26 28 29 30 Introduction The Aeroneb Solo System is an iteration of the Aeroneb Professional Nebulizer System The indications for use of the Aeroneb Solo Nebulizer System are given below The Aeroneb Solo System consists of the Aeroneb Solo nebulizer and the Aeroneb Pro X controller It is intended for hospital use only to nebulize 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 intermittent and continuous nebulization of pediatric 29 days or older and adult patients as described in this manual Indications for Use The Aeroneb Solo Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician prescribed solutions for inhalation to patients on and off ventil2. In the case of Aeroneb Solo the life of the nebulizer 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 and the continuous nebulization tube set have been qualified for use for a maximum of 7 days The user should note that use in excess of these periods is not qualified by Aerogen Aerogen Specifications Table 4 Physical Specification of the Aeroneb Solo System i l g 67 mm H x 48 mm W x 25 mm D Nebulizer Dimensions 2 6 Hx 1 88 Wx11 D 33mm H x 75mm W x 131mm D 1 3 H x 2 9 W x 5 2 D Controller Cable Length 1 8 m 5 9 ft AC DC Adapter Cable Length 2 1 m 6 7 ft Nebulizer Weight 13 5 g 0 5 oz nebulizer and plug Aeroneb Pro X Controller Dimensions Aeroneb Pro X Controller Weight 230 g 8 1 oz including battery and cable Nebulizer Capacity Maximum 6 mL Table 5 Environmental Specifications of the Aeroneb Solo System Maintains specified performance at circuit pressures up to 90 cm H O and temperatures from 5 C 41 F up to 45 C 113 F Operating Atmospheric Pressure 450 to 1100 mbars Humidity 15 to 95 relative humidity Noise Level lt 35 dB measured at 0 3 m distance Transient Temperature Range 20 to 60 C 4 to 140 F Storage amp Atmospheric Pressure 450 to 1100 mbars Transport Humidity 15 to 95
3. of time it takes from the start of nebulization until all the saline drug has been nebulized 4 Calculate the flow rate using the following equations Volume of normal saline or drug Flow rate in mL min beem 60 Nebulization time in seconds Flow rate in mL hr Nebulization time in seconds Volume of normal saline or drug x60 x 60 Aeroneb Solo System Instruction Manual Troubleshooting If these suggestions do not correct the problem discontinue use of any device that appears to be damaged or is not operating properly and contact your local Aerogen product sales representative Table 2 Aeroneb Pro X Troubleshooting It could mean If this happens The 30 Min indicator flashes during nebulization Battery power is low Try this Recharge battery see Recharging the battery Battery will not recharge Controller is connected to the AC DC adapter and the battery charging light is illuminated green and the 30 Min indicator light is flashing It may be time to replace the battery Contact your local Aerogen product sales representative Battery will not retain initial charge Rechargeable battery may need to be replaced Contact your local Aerogen product sales representative The 30 Min or Continuous light illuminates but aerosol is not visible No medication in nebulizer Refill medication through filler cap in the nebulizer see page 1
4. port or tubing is not occluded Do not use Adapter without a mouthpiece or facemask Visually check Adapter post rinsing to ensure that valves have not become dislodged Do not cover Adapter valves during use Do not use Adapter in conjunction with the Aeroneb Pro nebulizer Do not autoclave any component of the kit Ensure tubing is safely orientated to prevent strangulation hazard wy Nerogen Nebulization Modes Intermittent Mode Warnings e To avoid damage to the Aeroneb Solo do not use a syringe with needle e During use observe for correct functioning of the nebulizer e The maximum capacity of the nebulizer is 6 mL For intermittent doses less than or equal to 6 mL 1 Open the plug on the nebulizer 2 Use a pre filled ampoule or syringe to add medication into the filler port of the nebulizer Figure 11 3 Close the plug Figure 11 Filling the nebulizer with a pre filled ampoule 4 To start a 30 minute nebulization cycle press and release the blue on off power button Figure 4 The green 30 minute indicator light illuminates to indicate that the 30 minute nebulization cycle is in progress 5 To stop the nebulizer at any time press the on off power button The indicator turns off to indicate that nebulization has stopped Note Medication can be added to the Aeroneb Solo during nebulization This does not interrupt nebulization or ventilation Aeroneb Solo System Instruction Manual Continuous M
5. relative humidity Table 6 Power Specifications of the Aeroneb Solo System FRIWO AG AP1040 US AC DC adapter input 100 to 240 VAC 50 60 Hz output 9 V or internal rechargeable battery 4 8 V nominal output Power Source Note The Aeroneb Pro X controller is approved for use with Aerogen AC DC adapter AG AP1040 US Manufacturer Reference FRIWO FW7660 09 OVERSET url lt 8 Watts charging 2 0 Watts nebulizing Controller circuitry provides 4 kilovolt kV patient isolation and complies with IEC EN 60601 1 Patient Isolation Aeroneb Solo System Instruction Manual Performance Table 7 Performance Specifications of the Aeroneb Solo Flow Rate gt 0 2 mL min Average 0 38 mL min As measured with the Andersen Cascade Impactor e Specification Range 1 5 um e Average Tested 3 1 um harticle Size As per EN 13544 1 e Aerosol Output rate 0 30 mL min e Aerosol Output 1 02 mL emitted of 2 0 mL dose e Residual volume lt 0 1 mL for 3 mL dose Performance may vary depending upon the type of drug and nebulizer used For additional information contact Aerogen or drug supplier The temperature of the medication will not rise more than 10 C 18 F above ambient during normal use Table 8 shows the results of aerosol performance testing for the Aeroneb Solo using an 8 stage cascade impactor running at a continuous flow rate of 28 3 LPM Indicated ranges
6. 2M 17M 18 5M e 22F 22F vented Disposable Mask Kit International Pack of 5 AG AS1075 e 22F 22M 15F e 22F 22F vented Disposable Vented Elbow Pack of 5 AG AS1055 22F 22F vented Aerogen Table 3 Aeroneb Solo System Part Numbers Continued Description Part Number Continuous Nebulization Tube Set Tubing Pack of 5 AG AS3075 Continuous Nebulization Tube Set Syringe 60mL Pack of 5 AG AS3085 Continuous Nebulization Tube Set Syringe 60mL Pack of 50 AG AS3095 AC DC Adapter AG AP1040 US Aeroneb Pro X Controller AG PX1050 US Controller Cable AG AP1085 Universal Mounting Bracket AG AP1060 Equipment Mount Adapter AG AP1070 Aeroneb Solo Starter Kit Instruction Manual AG AS3050 US Aeroneb Solo Adapter Starter Kit Pack of 10 AG AS7500 US Aeroneb Solo Adapter Pack of 10 AG AS7000 US 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 Controller 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 has a defined life
7. 5 It may be time to replace the nebulizer See Warranty and Life of Product Refer to Aeroneb Solo parts list 30 Min or Continuous indicator does not light when on off power button is pressed There is no power to the System Verify that AC DC adapter is securely attached to controller Rechargeable battery is depleted Recharge battery see Recharging the battery Aerogen Table 2 Aeroneb Pro X Troubleshooting Continued If this happens It could mean Try this The fault indicator light illuminates The controller cable is incorrectly connected to the nebulizer or electronics are malfunctioning Verify that controller cable is correctly connected to both the nebulizer and the controller Medication is left in the nebulizer after nebulization cycle Nebulizer was not turned on or connected to power Ensure that nebulizer is connected to power and turned on Rechargeable battery is depleted Recharge battery see Recharging the battery A 30 minute cycle was selected when connected to the continuous feed system Run a continuous cycle It may be time to replace the nebulizer See Warranty and Life of Product Refer to Aeroneb Solo parts list Flashing amber light It may mean that it is time to replace controller Contact your local Aerogen Product sales representative Note The rechargeable battery in the Ae
8. ally the BD Plastipak setting This must be validated locally before use Refer to pump manual or manufacturer for guidance These pumps may also be used in accordance with local hospital or ward policies e Ensure that the tethered silicone plug is attached to the Aeroneb Solo when connecting tube set e Ensure that the tubing is safely orientated to prevent a trip hazard e Rising level of medication in the reservoir may occur if the Aeroneb Solo nebulizer is turned off while the feed system is still on or the nebulizer is not in its recommended orientation e The level of the medication in the reservoir of the Aeroneb Solo nebulizer should be periodically monitored to ensure that the fill rate of medication does not exceed the output 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 e Replace the tube set and syringe when changing the type of medication Aeroneb Solo System Instruction Manual Do not connect the tube set and syringe to non respiratory equipment Do not clean or sterilize Do not connect to any nebulizer other than the Aeroneb Solo Note Ifthe mains power is disconnected during a continuous nebulization cycle and reconnected within 10 seconds the controller shall return to continuous nebulization mode automatically Functional Test Perform a functional test of the Aeroneb Solo System prior to first use or at any tim
9. ation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance d 1 17 JP d 1 17 JP 80MHz to 800MHz d 2 33 JP 800MHz to 2 5GHz where P is the maximum output power rating of the transmitter in Watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol p Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the USB Controller System is used exceeds the applicable RF compliance level above the USB Controller System should be observed t
10. ation or other positive pressure breathing assistance Aerogen Aeroneb Solo System The Aeroneb Solo System includes the following components Figure 1 Aeroneb Solo System 1 2 3 4 Sy 6 Z 8 Pediatric adapters continuous nebulization tube set and Aeroneb Solo Adapter are Aeroneb Solo With Plug T Piece Adult Aeroneb Pro X Controller Controller Cable AC DC Adapter Universal Mounting Bracket amp Equipment Mount Adapter Continuous Nebulization Tube Set Aeroneb Solo Adapter sold separately Aeroneb Solo System Instruction Manual System Warnings Read and study all instructions before using the Aeroneb Solo system and accessories Only trained medical personnel should operate the device This is a single patient use device not to be used on more than one patient to prevent cross infection The components and accessories of the Aeroneb Solo system as packaged are not sterile Inspect all system and accessory parts before use Do not use if any parts are missing cracked or damaged or if there is any foreign matter present In such cases contact your Aerogen product sales representative Only use physician prescribed solutions that are approved for use with a general purpose nebulizer Consult drug manufacturer s instructions regarding suitability for nebulization Use only with Aeroneb Solo components connectors and accessories specified by Aerogen in this manual Do not u
11. cemask with low no oxygen flow A facemask is not provided Inspect for device integrity and correct valve placement prior to use 1 Insert Aeroneb Solo nebulizer firmly into Adapter in orientation shown in Figure 10 2 If supplemental oxygen is required firmly attach oxygen tubing to Adapter Note Oxygen flow rate should be set between 1 6 LPM for adult and a maximum of 2 LPM for pediatric patients less than 18 years of age 3 If an aerosol facemask is required remove mouthpiece and attach the aerosol facemask to Adapter Note When using an aerosol face mask a minimum oxygen flow of 1 LPM is required Add medication to nebulizer Connect cable to Aeroneb Solo and power on controller Introduce Adapter to patient and observe aerosol flow to ensure correct operation NO a P Remove excess rainout from Adapter periodically hourly with continuous nebulization 8 To ensure optimum performance of the Adapter remove any residue by rinsing through with sterile water shake off excess and allow to air dry Warnings e Do not use with a closed face mask or a standard oxygen mask e When using with an aerosol face mask always use supplemental oxygen flow of 1 6 LPM for adult and a maximum of 2 LPM for pediatric patients less than 18 years of age e Performance of the Adapter may vary depending upon the type of drug and Adapter configuration used Do not exceed recommended oxygen flow for system Ensure oxygen connection
12. correspond to confidence intervals with a confidence level of 95 Table 8 Aeroneb Solo Aerosol Performance Testing Albuterol Sulphate Budesonide Ipratropium 1mg ml 0 5mg ml 0 25mg ml Particle size um 2 90 3 23 3 07 3 42 3 45 3 79 Geometric Standard Deviation GSD 2 09 2 35 1 80 1 93 1 92 2 14 Emitted Dose of fill 97 23 99 30 97 61 98 64 94 12 97 84 Respirable Dose 0 5 5 0 um 67 66 73 50 71 78 76 69 62 32 66 90 of fill Coarse particle Dose gt 4 7 um 27 00 31 11 23 62 28 21 32 31 36 12 of fill Fine particle Dose lt 4 7 um 66 33 72 07 68 58 73 84 59 36 64 17 of fill Ultra fine Particle Dose lt 1 0 um 5 91 9 93 1 85 4 19 2 36 4 51 of fill Aerogen Table 9 shows the Inhaled Dose for the Aeroneb Solo Nebulizer and Adapter with supplemental gas flow measured on a breathing simulator Table 9 Inhaled Dose for the Aeroneb Solo and Adapter Gas Flow Rate Breathing Patient Interface LPM Profile Mouthpiece Open Facemask Valved Facemask Adult 73 5 61 6 N A 70 7 52 3 0 Pediatric 54 5 45 6 N A 52 9 42 5 Adult 73 8 59 2 44 0 37 7 65 4 45 3 2 Pediatric 55 2 40 9 34 4 29 2 42 4 34 7 6 Adult 52 1 47 3 41 6 34 7 48 4 39 5 Results are Inhaled Dose expressed as a of the Nominal Dose placed in the Aeroneb Solo Nebulizer across a range of supplementa
13. e nebulizer is on continuously and the medication is nebulized on a drop by drop basis Nebulization should be visible with regular intermittent pauses Medication level in the nebulizer reservoir should not rise during use 10 To stop the nebulizer at any time press the on off power button The indicator turns off to indicate that nebulization has stopped Aerogen s recommended input rate of medication into the Aeroneb Solo nebulizer during continuous nebulization is up to a maximum of 12 mL per hour The upper limit of 12 mL per 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 19 Warnings Specific to the Continuous Nebulization Tube Set e It is important to ensure that the maximum flow rate through the tube set into the nebulizer must not exceed the output rate of the nebulizer Check for leaks from the system prior to and during use The graduations on the syringe are for indication use only Store at room temperature and use product within labelled shelf life 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 e The recommended syringe pump software setting with the Aerogen syringe is typic
14. e to verify proper operation This test is to be carried out prior to inserting the neb into a circuit or accessory d Visually inspect each part of the System for cracks or damage and replace if any defects are visible Pour 1 6 mL of normal saline 0 9 into the nebulizer Connect the nebulizer to the controller using the controller cable Connect the AC DC adapter to the controller and plug the AC DC adapter into an AC power source Press and release the blue on off power button and verify that the green 30 Min indicator light illuminates and that aerosol is visible Disconnect the AC DC adapter from the controller and verify that nebulization continues and that the battery status indicator turns off Power off the controller Reconnect the AC DC adapter to the controller Press and hold the button for at least three seconds Verify that the green Continuous indicator light illuminates and that aerosol is visible Turn the System off and verify that the 30 Min and Continuous indicators are off Aerogen Aeroneb Solo Aerosol Flow Rate Calculation Flow rates may vary between individual Aeroneb Solo nebulizers The minimum flow rate for all Aeroneb Solo nebulizers is 0 2 mL per minute In order to calculate the flow rate of an individual Aeroneb Solo nebulizer 1 Transfer 0 5 mL of normal saline 0 9 or intended drug into the Aeroneb Solo medication cup Turn on the nebulizer Using a stop watch measure the length
15. e by pushing the nebulizer firmly onto the T piece 2 Insert the Aeroneb Solo 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 Note For use with other accessories refer to Figure 8 Figure 9 and Figure 10 3 Connect the Aeroneb Pro X controller to the Aeroneb Solo using the nebulizer cable 4 To operate on AC power the primary mode of operation connect the Aeroneb Pro X AC DC adapter to the Aeroneb Pro X controller 5 Plug the adapter into an AC power source 6 Aeroneb Pro X can be battery operated for portable applications The rechargeable battery can power the System for up to 45 minutes when fully charged In the case of AC power failure the controller will automatically switch to battery operation ENK nena Use the universal mounting bracket to attach the controller to an IV pole or bed rail in either a vertical or horizontal orientation Figure 3 Where a standard equipment mount is available use the equipment Mount adapter to support the controller Figure 3 Eh A Da Standard Equipment Mount Vertical Horizontal Equipment Universal Mounting Bracket Universal Mounting Bracket Mount Adapter Figure 3 Aeroneb Pro X Controller and universal mounting bracket configurations Warnings To ensure uninterrupted operation of the Aeroneb Solo secure both the AC DC adapter cable and the controller cable so they cannot beco
16. ebulizer system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Aeroneb Solo nebulizer system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Aeroneb Solo nebulizer system as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz power of transmitter W d 1 17 JP d 1 17 JP d 2 33 JP 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 75 1 1 17 1 17 2 33 10 3 70 3 70 7 36 100 11 70 11 70 23 30 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts w according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Aerogen Guidance and manufacturer s declaration electromagnetic immun
17. hold the On Off button for On Off Power Button greater than 3 seconds from off e Pressing during nebulization turns off power to the nebulizer e Green Battery fully charged Battery Statis e Amber ind ae in i I Indicator s aa No light Battery in operation Aerogen Recharging the Battery To recharge the battery connect the AC DC adapter to the controller and connect to AC power source The battery status indicator is amber while charging and green when fully charged If the controller is placed in long term storage it is recommended that the battery be recharged every 3 months Allow a minimum of four hours for the internal battery to fully recharge Cleaning the Pro X Controller Cleaning of controller and controller cable AC DC adapter and mounting brackets ill Wipe clean with an alcohol based disinfectant wipe or a quaternary ammonium compound based disinfectant wipe 2 Check for exposed wiring damaged connectors or other defects and replace controller if any are visible 3 Visually inspect for damage and replace the controller if any damage is observed Warnings e Do not immerse or autoclave the Aeroneb Pro X Controller cable or AC DC adapter e Do not place the Aeroneb Pro X in an incubator during use e Do not use abrasive or sharp tools e Do not spray liquid directly onto the controller e Do not wrap the nebulizer cable tightly around any of the system components e Do
18. interruption it input lines for 5 cycles for 5 cycles is recommended that the Aeroneb IEC 61000 4 11 Solo nebulizer system be powered 70 Ut 70 Ut from an uninterruptible power 30 dip in Ut for 25 cycles 30 dip in Ut for 25 cycles supply or battery lt 5 Ut lt 5 Ut gt 95 dip in Ut gt 95 dip in Ut for 5 sec for 5 sec Power 3 A m 3 A m Power frequency magnetic fields frequency should be at levels characteristic 50 60 Hz of a typical location in a Magnetic field typical commercial or hospital IEC 61000 4 8 environment Note Ut is the A C mains voltage prior to application of the test level Aeroneb Solo System Instruction Manual Guidance and manufacturer s declaration electromagnetic immunity for a system that is not life supporting This Aeroneb Solo nebulizer system is intended for use in the electromagnetic environment specified below The customer or the user of the Aeroneb Solo nebulizer system should assure that it is used in such an environment Immunity Test IEC EN 60601 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF IEC EN 61000 4 6 Radiated RF IEC EN 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 Vrms 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the USB Controller System including cables than the recommended separ
19. ity This Aeroneb Solo nebulizer system is intended for use in the electromagnetic environment specified below The customer or the user of the Aeroneb Solo nebulizer system should assure that it is used in such an environment Immunity Test IEC EN 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC EN 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast Transient burst 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment IEC EN 1 kV for input 1 kV for input 61000 4 4 output lines output lines Surge 1 kV line s to 1 kV line s to line s Mains power quality should be that line s of a typical commercial or hospital IEC EN environment 61000 4 5 2 kV Line s to 2 kV Line s to earth earth Voltage lt 5 Ut lt 5 Ut Mains power quality should be dips short gt 95 dip in Ut gt 95 dip in Ut for that of a typical commercial or interruptions for 0 5 cycle 0 5 cycle hospital environment If the user of and voltage the Aeroneb Solo nebulizer system variations on 40 Uu 40 Ut requires continued operation power supply 60 dip in Ut 60 dip in Ut during power mains
20. l gas flows The results provided are the maximum and minimum values for 3 devices tested at each flow rate with each interface Adult Profile 500ml Vt 15BPM 1 1 I E Pediatric Profile 155ml Vt 25 BPM 1 2 I E Aeroneb Solo System Instruction Manual Symbols Symbol Meaning Symbol Meaning Serial number designation where YYXXXXX YY is the year of manufacture and F XXXXX is the serial number j Transient storage temperature limitations 20 C to 60 C Attention consult accompanyin Quantity ion u i S i Ah EE QTY Number of units contained in documents package S Federal US Law restricts this Degree of protection against i S Rx Only device to sale by or on the order of a IPX1 dripping water physician Certified by TUV with respect to l ll i t IEC EN ol Glass Bees per lke electric shock fire and mechanical hazards r Type BF equipment per IEC EN YP aE p Controller Input DC voltage 60601 1 I On Off power button standby Fr Controller Output AC voltage 30 minute operating mode Output Continuous operating mode Battery status indicator Refer to instruction manual booklet Aerogen Appendix 1 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 com
21. me 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 The AC DC adapter is the means of isolating the Aeroneb Solo system from the mains power supply The continuous mode can only be operated from AC power supply Do not over tighten knob on the universal mounting bracket Aeroneb Solo System Instruction Manual Aeroneb Pro X Controller On Off Power e 30 Min Press amp Release e Continuous Mode 3 Sec hold from off Fault Indicator 30 Minute Indicator Continuous Mode Indicator Controller Battery Status Indicator 9V DC Input Cable Input Figure 4 Aeroneb Pro X Controls amp indicators Table 1 Aeroneb Pro X Controls amp Indicators Control Indicator Function 30 Min Indicator Green steadily lit 30 minute nebulization cycle on Green flashing Low battery power Nebulizer automatically powers off after 30 minutes have elapsed Continuous Indicator Green steadily lit Continuous nebulization cycle on Nebulizer 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 To operate in 30 minute mode press the On Off button once To operate in continuous mode press and
22. munities 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 US has no connection to earth ground because the necessary level of protection is achieved through the use of double insulation Warnings e Only use the Aeroneb Solo nebulizer with components specified in the Instruction Manual Use of the Aeroneb Solo nebulizer with components other than those specified in the Instruction Manual may result in increased emissions or decreased immunity of the Aeroneb Solo nebulizer system e 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 e The Aeroneb Solo needs special precautions regarding electromagnetic compatibility EMC and must be installed and put into service according
23. neb Solo on dry side of humidifier 3 Follow ventilator manufacturer instructions for performing a leak test after inserting or removing the nebulizer Warnings 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 Do not use a filter or heat moisture exchanger HME between the nebulizer and patient airway Aeroneb Solo System Instruction Manual Installation for use Off Ventilator Use with a Facemask Mask kits which include a vented elbow and mask elbow are available separately see part numbers page 22 1 When using a mask connect the vented elbow mask elbow and mask to the nebulizer by firmly pushing the parts together 2 Rotate the vented elbow to suit the position of the patient Figure 8 Facemask Elbow Vented Elbow Patient Upright Patient Reclined Figure 8 Connecting to a mask Use with a Mouthpiece The Aeroneb Solo is compatible with any standard ISO 22 mm nebulizer mouthpiece inserted into the adult T piece When using a mouthpiece connect the nebulizer to the T piece and then connect the T piece to the mouthpiece by pushing the parts firmly together as shown in Figure 9 Figure 9 Connecting to a mouthpiece Warning To ensure correct nebulizati
24. not use in the presence of devices generating high electromagnetic fields such as magnetic resonance imaging MRI equipment The Aeroneb Pro X controller contains a nickel metal hydride NiMH rechargeable battery which should be disposed of in accordance with local governing regulations at the end of its useful life Follow local laws and recycling plans regarding disposal or recycling of components batteries and packaging Aeroneb Solo System Instruction Manual Installation for use with a Ventilator T Pieces Connection to a Breathing Circuit 1 For 22mm adult breathing circuits connect the nebulizer with adult T piece into the inspiratory limb of the breathing circuit before the patient Y Figure 5 Figure 5 Connecting the Aeroneb Solo to a breathing circuit Note Figure 5 shows adult configuration only For 15mm pediatric breathing circuits connect the nebulizer with the pediatric T piece into the inspiratory limb of the breathing circuit before the patient Y The Aeroneb Solo can connect 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 Figure 6 Figure 6 Connecting to a pediatric breathing circuit 0 pera 2 The Aeroneb Solo can be placed on the dry side of the humidifier as shown in Figure 7 The Aeroneb Solo can be used with a nasal interface in this configuration Figure 7 Aero
25. o verify normal operation If abnormal performance is observed additional measures may be necessary such as re orientating or relocating the USB Controller System b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m Aerogen Aerogen www aerogen com CE 0050 PHONE 2014 Aerogen Ltd Part No AG AS3050 US P N 30 674 Rev D Manufacturer Aerogen Ltd Galway Business Park Dangan Galway Ireland INTL 353 91 540 400 U S 1 886 423 7643
26. ode Continuous Nebulization Tube Set The Aerogen Continuous Nebulization Tube Set is an accessory specific to the Aeroneb Solo nebulizer which enables safe continuous infusion of liquid medication for aerosolization Tethered Cap Tubing Nebulizer End Syringe Cap Tubing Syringe End Figure 12 Continuous Nebulization Tube Set Note Place the syringe cap on the syringe after it is filled with medication 1 Ensure the Aeroneb Solo nebulizer is firmly fitted into the Aeroneb Solo T piece in the breathing circuit Remove the syringe cap from the medication filled syringe Attach the syringe end of the tubing onto the syringe Prime the tubing until the medication reaches end of tubing Point A Note The tubing priming volume is maximum 3 65 mL 5 Unplug the tethered cap from the Aeroneb Solo nebulizer but do not remove it from the nebulizer 6 Screw the nebulizer end of the tubing onto the top of the nebulizer 7 Insert the syringe filled with medication into the syringe infusion pump pump not shown in Figure 12 and set the appropriate flow rate refer to pump manual or manufacturer for guidance ue N Nerogen 8 To start a continuous nebulization cycle press and hold the blue On Off power button from the off state for at least three seconds Verify the green continuous nebulization indicator light is on Figure 4 9 Observe nebulizer for correct operation During continuous nebulization th
27. on maintain the nebulizer in a vertical orientation Figure 8 amp Figure 9 2N Nerogen Use with a Nasal Interface The Aeroneb Solo can be used on off ventilator with a nasal interface when configured with a humidifier Figure 7 Aeroneb Solo Adapter The Aeroneb Solo Adapter is an accessory specific to the Aeroneb Solo nebulizer It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to pediatric 29 days or older and adult patients in hospital use environments via mouthpiece or aerosol facemask 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 for children under 5 years of age The Aeroneb Solo Adapter is a single patient use device with a validated defined life of e In intermittent use for a maximum of 20 treatments which is based upon a typical usage profile of four 3ml doses per day over 5 days with an average treatment time of 9 minutes or e In continuous use for a maximum of 3 hours The Aeroneb Solo Adapter can be used in conjunction with the Aeroneb Solo Continuous Nebulization Tube Set see page 16 Mouthpiece Aeroneb Solo Adapter Aeroneb Solo p Oxygen Tubing Face Mask Figure 10 Assembly of Aeroneb Solo Adapter Aeroneb Solo System Instruction Manual Optimal aerosol delivery is achieved with valved mouthpiece or valved fa
28. roneb Pro X controller should only be replaced by Aerogen authorized personnel contact your Aerogen product sales representative Aeroneb Solo System Instruction Manual Parts List Table 3 Aeroneb Solo System Part Numbers Description Aeroneb Solo Starter Kit e Aeroneb Solo nebulizer x 2 e Adult T piece with silicone plug x 2 e Aeroneb Pro X Controller e Universal Mounting Bracket e AC DC Adapter e Instruction Manual Part Number AG AS3000 US Aeroneb Solo Convenience Kit Pack of 5 e Aeroneb Solo nebulizers e Adult T pieces with silicone plugs AG AS3300 US Aeroneb Solo Convenience Kit Pack of 10 e Aeroneb Solo nebulizers e Adult T pieces with silicone plugs AG AS3350 US Aeroneb Solo Nebulizers Pack of 5 AG AS3100 Aeroneb Solo Nebulizers Pack of 10 AG AS3200 Disposable Adult T piece Pack of 10 AG AS3010 e 22M 22F 22M Disposable Pediatric T piece Pack of 10 AG AS3020 e 15M 22F 15M Disposable Pediatric T piece Adapter Kit Pack of 10 AG AS3025 e T Piece 15M 22F 15M e Adapters 15M 10M 7 5M 15F 10M 7 5F Disposable Pediatric T piece Pack of 10 AG AS3035 e 12M 22F 12F Fits Fisher A Paykel Circuit Disposable Pediatric T piece Pack of 10 AG AS3036 e 10M 22F Fits SLE Circuit T piece Silicone Plug AG AS3450 For use with AG AS3010 AG AS3020 AG AS3025 amp AG AS3036 Disposable Mask Kit US Pack of 5 AG AS1065 e 2
29. se beyond defined life see page 13 for Aeroneb Solo Adapter and page 24 for Aeroneb Solo System To avoid the risk of fire do not use in the presence of flammable substances or flammable anaesthetic mixtures combined with air 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 nebulizer or T piece plastics Do not use to aerosolize alcohol based medications which can ignite in oxygen enriched air under high pressure Do not autoclave any component or accessory of the Aeroneb Solo system Do not modify this equipment without authorization from the manufacturer Aerogen To avoid damage to the nebulizer e Do not apply undue pressure to the domed aperture plate in the center of the nebulizer e Do not push out the vibrating mesh aerosol generator e Do not use a syringe with a needle to add medication e Do not attempt to clean the nebulizer Do not use or store outside of specified environmental conditions Federal US Law restricts this device to sale by or on the order of a physician Aeroneb Solo System Instruction Manual Assembly amp Installation Aeroneb Solo System Set Up Perform a functional test of the Aeroneb Solo before use as described in the Functional Test section of this manual See page 18 Figure 2 Assembly of Aeroneb Solo System 1 Connect the Aeroneb Solo to the T piec
30. to the EMC information provided in the Instruction Manual e Portable and mobile radio frequency RF communication devices can disrupt medical electrical equipment Aeroneb Solo System Instruction Manual Appendix 1 EMC Tables The following tables are provided in accordance with IEC EN 60601 1 2 Guidance and manufacturer s declaration electromagnetic emissions The Aeroneb Solo nebulizer system is intended for use in the electromagnetic environment specified below The customer or the user of the Aeroneb Solo nebulizer system should assure that it is used in such an environment Emissions test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The Aeroneb Solo nebulizer system uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class B The Aeroneb Solo nebulizer system is suitable Harmonic emissions Compliant for use in all establishments including domestic IEC 61000 3 2 establishments and those directly connected to Voltage fluctuations Compliant the public low voltage power supply network that flicker emissions supplies buildings used for domestic purposes IEC 61000 33 Recommended separation distances between portable and mobile RF communication equipment and the Aeroneb Solo nebulizer system This Aeroneb Solo n
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