AeroNeb Pro Instruction Manual
Contents
1. 28 TOU IES MOG UNG a Pae ak E 34 Order TUMBSIS isc crete a ate Ka Ga PG ee 37 DDCCINCATIONS aL 39 PHYSICA cern erence irene re meres 39 EVIVIFOMINI GN all ae ta ee KA 39 EILSE E aaa aa ea hee anaes 40 Appendix 1 EMC Tables 43 Aeroneb Professional Nebulizer System Instruction Manual List of Figures Figure 1 2 Figure 2 Aeroneb Pro controls and indicators 10 Figure 3 Connecting nebulizer unit to T piece 13 Figure 4 Connecting control module and nebulizer unit 14 Figure 5 Connecting the AC DC adapter 15 Figure 6 Connecting an adult breathing circuit 17 Figure 7 Connecting to a pediatric breathing circuit 17 Figure 8 Connecting to a neonatal breathing circuit 17 Figure 9 Alternative neonatal breathing circuit USING neonate 18 Figure 10 Control module and universal mounting bracket ETI AI Pa A AN A SR 18 Figure 11 Control module and universal mounting bracket 19 Figure 12 Equipment mount adapter2. 19 Figure 13 Connecting 21 Figure 14 Connecting to a 22 Figure 15 Filling the nebulizer unit with pre filled 23 Figure 16 Maximum fill indication 24 Figure 17 Starting and stopping nebulization 26 List of Tables Table 1 Aeroneb Pro 8 Table 2 Aeroneb Pro controls and 11 Table 3 Aeroneb Pro troubleshooting 34 Table 4 Aeroneb Pro parts list 37 Aeroneb Professional Nebulizer System Instruction Manual Introduction The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician prescribed medications for inhalation that are approved for use with a general purpose nebulizer This device can be used by patients on and off mechanical ventilation or other positive pressure breathing assistance Aeroneb Pro is suitable for use by neonate pediatric to adult patients as described in this manual It incorporates the Aerogen OnQ Aerosol Generator Aeroneb Pro is intended for hospital use only It is designed to operate in line wi
3. To avoid the risk of fire do not use in the presence of flammable substances Do not modify this equipment without the authorization of the manufacturer 4 Aeroneb Professional Nebulizer System Instruction Manual Warnings To avoid damage to the nebulizer Prior to use autoclave according to specified directions and temperature given in the Cleaning disinfection sterilization section of this Instruction Manual only Any deviation from directions given in this Instruction Manual may cause damage to the nebulizer unit and render it inoperable 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 clean the nebulizer unit 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 Aeroneb Pro nebulizer system sales representative Disconnect nebulizer unit from control module before cleaning Do not immerse or autoclave the control module or AC DC adapter Disassemble all parts before autoclaving 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 Aeroneb Pr
4. for 20 minutes with drying cycle sometimes referred to as a Prion cycle Aeroneb Professional Nebulizer System Instruction Manual 31 NOTE Sterilization using the long autoclave cycle iii above may cause some areas of the nebulizer to become discolored This is not indicative of the performance of the nebulizer unit sterilize with hydrogen peroxide gas plasma place wrapped parts ina STERRAD System and use the long cycle CAUTION Users should refer to the product labelling for the STERRAD 1005 Sterilization System for specific instructions regarding its proper operation Prior to next use 1 Check for cracks or damage and replace if any defects are visible ii Perform a functional test as described in this manual Cleaning of mounting brackets Wipe clean with a damp cloth and mild liquid detergent Do not use abrasive or sharp tools 32 Aeroneb Professional Nebulizer System Instruction Manual Cleaning of control module control module cable and AC DC adapter 1 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 if any are visible 3 Visually inspect for damage and replace the control module if any damage is observed CAUTIONS Do not autoclave Do not use abrasive or sharp tools Do not spray liquid directly onto the control modu
5. EN 61000 4 2 Electrical fast Transient burst EN 61000 4 4 EN 61000 4 5 IEC EN 60601 Test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode Compliance level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Aeroneb Professional Nebulizer System Instruction Manual Voltage dips short interruptions and voltage variations on power supply input lines EN 61000 4 11 Power frequency 50 60 Hz Magnetic field EN 61000 4 8 lt 5 Ut gt 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles lt 5 Ut gt 95 dip in Ut for 5 sec lt 5 Ut gt 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles lt 5 Ut gt 95 dip in Ut for 5 sec Mains power quality should be that of a typical commercial o
6. Nebulizer System Instruction Manual Table 3 Aeroneb Pro troubleshooting If this happens It could mean Try this The 75 Min or 30 Min indicator lights but aerosol is not visible No medication in nebulizer unit Refill medication through filler cap in the nebulizer unit see Adding medication during nebulization Nebulizer unit has not been properly cleaned Clean nebulizer unit see Cleaning and Sterilization It may be time to replace the nebulizer unit See Warranty and Life of Product Refer to Aeroneb Pro parts list 15 Min or 30 Min 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 control module Rechargeable Recharge battery connected or electronics are malfunctioning battery is see Recharging depleted the battery The fault The control Verify that control indicator lights module cable is module cable is incorrectly correctly connected to both the nebulizer unit and the control module Aeroneb Professional Nebulizer System Instruction Manual 35 Table 3 Aeroneb Pro troubleshooting Normal Saline 0 9 should take no longer than 15 minutes to nebulize not been properly cleaned If this happens It could mean Try this Longer than Rechargeable Recharge battery expected battery is depleted see
7. Silicone Plug Pack of 5 Adult T piece with silicone plug Pack of 5 AG AP1010 22 mm Female 22 mm Female Elbow 22 mm Male Pediatric T piece with silicone plug Pack of 5 AG AP1020 15 mm Male 22 mm Female Elbow 15 mm Female Neonate T Piece with silicone plug Pack of 5 12 mm Male 22 mm Female Elbow 12 mm Female AG AP1035 Fits Fisher amp Paykel Neonate breathing circuit Neonate T Piece with silicone plug Pack of 5 AG AP1036 10 mm Female 22 mm Female Elbow 10 mm Male Pediatric T Piece amp Neonate Adapter Kit Pack of 5 e 15mm Male 22 mm Female Elbow 15 mm Female e Silicone Plug AG AP1015 e Adapters 15 mm Male 10 mm OD to 7 5 mm OD 15 Female 10 mm OD and 7 5 mm ID Neonate Adapter Kit Pack of 5 e 15mm Male 10 mm OD to 7 5 mm OD AG AP1025 15mm Female 10 mm OD 7 5 mm ID Vented Elbow Pack of 5 AG AP1055 consult your local representative for the order code extension specific to your country and for pricing information Aeroneb Professional Nebulizer System Instruction Manual 37 Table 4 Aeroneb Pro parts list continued Mask Kit US Pack of 5 Kits e 17 mm Male 22 mm Male Elbow AG AP1065 e 22 mm Female 22 mm Female Vented Elbow Mask Kit International Pack of 5 Kits e 22 mm female 22 mm Male Elbow AG AP1075 e 22 mm female 22 mm Female Vented Elbow consult your local representative for the order code extension specific to your country and for prici
8. 3 4 5 The nebulizer unit holds up to 10 mL of liquid medication The nebulizer unit is translucent to allow visual monitoring of medication levels and aerosolization When the nebulizer unit is connected into the breathing circuit the filler cap can be opened or removed from the nebulizer unit 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 The T piece securely connects the nebulizer unit into the breathing circuit and can be easily removed for cleaning The T piece connections are standard male and female 22 mm ISO conical ports and connect to standard patient breathing circuits The contro 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 contro module cable and the AC DC adapter The control module also includes indicators for nebulization cycle selection 15 or 30 minutes battery charge status and fault conditions A universal mounting bracket clamps the control module to standard IV poles and medical rail systems An equipment
9. Module Input DC voltage Control Module Output AC voltage 8 Aeroneb Professional Nebulizer System Instruction Manual Table 1 Aeroneb Pro symbols Battery status indicator Fragile handle with care Transient storage temperature limitations 20 C to 60 C Keep dry This device complies with the requirements of the Medical Devices Directive 93 42 EEC Consult Instructions for Use Manufacturer Refer to instruction manual booklet Classified by TUV with respect to electric shock fire and mechanical hazards Aeroneb Professional Nebulizer System Instruction Manual 9 Controls and indicators On Off Power Fault Indicator Timer Selection 30 Min Indicator Battery Status 20 Indicator 15 Min Indicator Control Module wee Cable Input Figure 2 Aeroneb Pro controls and indicators 10 Aeroneb Professional Nebulizer System Instruction Manual Table 2 Aeroneb Pro controls and indicators Conitrol indicator 15 Min indicator e Green steadily lit 15 minute nebulization cycle on e Green flashing Low battery power e Nebulizer unit automatically powers off after 15 minutes have elapsed 30 Min indicator e Green steadily lit 30 minute nebulization cycle on e Green flashing Low battery power e Nebulizer unit automatically powers off after 30 minutes have elapsed Fault indicator e Amber Faulty electrical connection On Off power e Pres
10. Recharging the treatment time battery e g 3 ml of Nebulizer unithas Clean nebulizer see Cleaning and Sterilization It may be time to replace the nebulizer unit See Warranty and Life of product Refer to Aeroneb Pro parts list Medication is left in the nebulizer unit 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 Nebulizer unit has not been properly cleaned Clean nebulizer see Cleaning and Sterilization A 15 minute cycle was selected anda volume greater than 3 mL was added to the nebulizer unit Run an additional 15 minute cycle When delivering a dose greater than 3 mL select the 30 minute cycle It may be time to replace the nebulizer unit See Warranty and Life of Product Refer to Aeroneb Pro parts list Note The rechargeable battery in the control module should only be replaced by Aerogen authorized personnel contact your Aeroneb Pro nebulizer system sales representative 36 Aeroneb Professional Nebulizer System Instruction Manual Order numbers Table 4 lists the Aeroneb Pro nebulizer system order numbers see Figure 7 for pictures Table 4 Aeroneb Pro parts list Description Aeroneb Professional Nebulizer System Nebulizer unit with filler cap
11. aq gt Aeroneb 0 Micropump Nebulizer Instruction Manual OA 15 15 Aeroneb Yo Aerogen Aeroneb Professional Nebulizer System Instruction Manual This page has been intentionally left blank Table of contents MVE OO CU ON ce Jas ee ate 1 SYSTEM NGA ANE 2 Warnings saa Aa a 4 VV GRINS i nua onder 5 Electromagnetic 6 Warning 7 SYMBOLS sanak aia a aaa nga ga a gag ag veda aa a aa aga na aan eag 8 MAT TATU ABEN 12 IPE OF Prodo 12 Assembly Installation ccccccsseeeecesseeeseeseeeeseeseeeees 13 Recharging the Battery 15 Installation for use with a 16 Installation for use with 20 Installation for use with a 22 Adding IMEGICATION aan 23 NGDUIZAaNOT asang aaa a aad 25 PUI CLIO NANG Seis oa ast ge yal Naga seo AN 27 Cleaning disinfection and sterilization
12. ask Elbow Vented Elbow Patient Upright Patient Reclined Figure 13 Connecting to a mask Aeroneb Professional Nebulizer System Instruction Manual 21 Installation for use with a mouthpiece Aeroneb Pro works with any standard ISO 22 mm nebulizer mouthpiece inserted into the adult T piece When using a mouthpiece connect the nebulizer unit to the T piece as shown in Figure 3 in this manual and then connect the to the mouthpiece by pushing the parts firmly together Figure 14 Figure 14 Connecting to a mouthpiece CAUTION To ensure proper nebulization maintain the nebulizer in a vertical orientation Figure 14 22 Aeroneb Professional Nebulizer System Instruction Manual Adding medication 1 Open the filler cap tab on the nebulizer unit 2 Use a pre filled ampoule or syringe to add medication into the filler port of the nebulizer Figure 15 3 Close the filler cap tab CAUTION To avoid damage to the nebulizer unit do not use a syringe with needle The maximum capacity of the nebulizer unit is 10 mL Do not fill the nebulizer unit beyond the maximum fill indication point Figure 16 The underside of the filler cap represents maximum fill indication point Figure 15 Filling the nebulizer unit with a pre filled ampoule Note Medication can also be added in this manner during nebulization This does not interrupt nebulization or ventilation Aeroneb Prof
13. ce 2 Always perform a leak test of the breathing circuit after inserting or removing the nebulizer unit Follow ventilator manufacturer instructions for performing a leak test 3 Use the universal mounting bracket to attach the control module to an IV pole or bed rail in either a vertical or horizontal orientation Figure 10 and Figure 11 Do not over tighten knob Where a standard equipment mount is available use the equipment mount adapter to support the control module Figure 12 Figure 10 Control module and universal mounting bracket vertical 18 Aeroneb Professional Nebulizer System Instruction Manual Figure 11 Control module and universal mounting bracket horizontal Standard equipment mount Figure 12 Equipment mount adapter Aeroneb Professional Nebulizer System Instruction Manual 19 Installation for use with a mask Mask kits which include a vented elbow and mask elbow are available separately see Order numbers section Contact your Aeroneb Pro nebulizer system sales representative for ordering information 1 When using a mask connect the vented elbow mask elbow and mask to the nebulizer unit by firmly pushing the parts together 2 Rotate the vented elbow to suit the position of the patient Figure 13 CAUTION To ensure proper nebulization maintain the nebulizer in a vertical orientation Figure 13 20 Aeroneb Professional Nebulizer System Instruction Manual Facem
14. es Aeroneb Professional Nebulizer System Instruction Manual 43 The following Tables are provided in accordance with IEC EN 60601 1 2 Guidance and manufacturer s declaration electromagnetic emissions The Aeroneb Pro nebulizer system is intended for use in the electromagnetic environment specified below The customer or the user of the Aeroneb Pro nebulizer system should assure that it is used in such an environment Compliance Electromagnetic environment guidance The Aeroneb Pro nebulizer system uses RF energy only for Emissions its internal function Therefore CISPR 11 Group 1 its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions The Aeroneb Pro nebulizer Harmonic system is suitable for use in all emissions establishments including EN 61000 3 2 Class A domestic establishments and Voltage those directly connected to the jan e public low voltage power supply flicker network that supplies buildings b used for domestic purposes emissions EN 61000 3 3 Class A Aeroneb Professional Nebulizer System Instruction Manual Recommended separation distances between portable and mobile RF communication equipment and the Aeroneb Pro The Aeroneb Pro nebulizer system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Aeroneb Pro nebulizer system can help pre
15. essional Nebulizer System Instruction Manual 23 Max fill indication point Figure 16 Maximum fill indication point 24 Aeroneb Professional Nebulizer System Instruction Manual Nebulization For doses less than or equal to 3 mL 1 To start a 15 minute nebulization cycle add the medication and press and release the blue On Off power button Figure 17 The green 75 Min indicator lights to indicate that the 15 minute nebulization cycle is in progress For doses greater than 3 mL 2 To start a 30 minute nebulization cycle add the medication and press and hold the blue On Off power button for at least three seconds The green 30 Min indicator lights to indicate that the 30 minute nebulization cycle is in progress To stop the nebulizer at any time press the On Off power button The indicator turns off to indicate that nebulization has stopped Note When delivering a dose greater than 3 mL select the 30 minute cycle Aeroneb Professional Nebulizer System Instruction Manual 25 On Off Power Button Press and release to select 15 min Press and hold for three seconds to select 30 min 30 Min Indicator 15 Min Indicator Figure 17 Starting and stopping nebulization 26 Aeroneb Professional Nebulizer System Instruction Manual Functional test Perform a functional test of Aeroneb Pro prior to first use after each sterilization before each patient use or at any time to verify pr
16. ife of the product 12 Aeroneb Professional Nebulizer System Instruction Manual Assembly and Installation 1 Clean and sterilize the nebulizer unit and T piece s as described in the Cleaning disinfection and sterilization section of this manual Note The nebulizer unit and T piece as packaged are not Sterile 2 Perform a functional test of Aeroneb Pro before use and between patients as described in the functional test section of this manual Insert the filler cap into the opening on the nebulizer unit 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 Aeroneb Professional Nebulizer System Instruction Manual 13 5 Connect the control module and the nebulizer unit together using the control module cable Figure 4 Figure 4 Connecting control module and nebulizer unit 6 To operate on AC power the primary mode of operation insert the AC DC adapter connector into the control module and plug the adapter into an AC power source Figure 5 7 Aeroneb Pro 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 control module will automatically switch to battery operation Note Allow a minimum of four hours for the internal battery to fully recharge Note To ensure uninterru
17. le Do not immerse control module in liquid Caution The Aeroneb Pro nebulizer unit contains active electronic components Aerogen has validated the methods of cleaning disinfection and sterilization above The use of any other means of cleaning disinfection or sterilization has not been validated and is likely to reduce the life of your nebulizer and will invalidate your warranty Aeroneb Professional Nebulizer System Instruction Manual 33 Troubleshooting If these suggestions not correct the problem discontinue use of any device that appears to be damaged or is not operating properly and contact your local Aeroneb Pro nebulizer system sales representative Table 3 Aeroneb Pro troubleshooting If this happens It could mean Try this The 15 Min or 30 Min indicator flashes during nebulization Battery power is low Recharge battery see Recharging the battery Battery will not recharge Constant green light showing on the battery status indicator and flashing green light on either the 15 Min or 30 Min indicator light when the control module is connected to the AC DC adapter It may be time to replace the battery Contact your local Aeroneb Pro nebulizer system sales representative Battery will not retain initial charge Rechargeable battery may need to be replaced Contact your local Aeroneb Pro sales representative 34 Aeroneb Professional
18. m Instruction Manual 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 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 Aeroneb Professional Nebulizer System Instruction Manual 2 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 Aeroneb Pro nebulizer system is used exceeds the applicable RF compliance level above the Aeroneb Pro nebulizer system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary s
19. mount adapter mounts the control module on standard equipment mounts Pediatric T piece neonate adapters mask adapter kits elbow connectors and mouthpiece are sold separately Aeroneb Professional Nebulizer System Instruction Manual Warnings Read and study all instructions before using Aeroneb Pro Only medical personnel should operate the device During use observe for correct functioning of the nebulizer by regularly verifying aerosol is visible and no flashing indicator lights Do not use a filter or heat moisture exchanger HME between the nebulizer and patient airway Do not attach a continuous supply of medication to the nebulizer the device operates in 15 or 30 minute cycles Clean sterilize assemble and perform a functional test page 27 according to the instructions in this manual before first use and between patients 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 To ensure optimum drug administration consult the drug manufacturer s instructions regarding suitability for nebulization Do not use in the presence of a flammable anesthetic mixture combined with air or with oxygen or nitrous oxide Do not use to aerosolize alcohol based medications which can ignite in oxygen enriched air under high pressure
20. nect the nebulizer with the Neonate T piece 30 cm 12 in back from the patient Y Figure 9 WARNING Always maintain the nebulizer in a vertical orientation with the filler cap uppermost while in the patient circuit Figures 6 7 8 and 9 This orientation prevents condensate from blocking the nebulizer and ensures proper nebulization Always visually inspect the nebulizer prior to placing in the ventilator circuit to assure that no secretions are blocking the OnQ Aerosol Generator When removing the nebulizer unit from the patient circuit always replace the T piece plug to maintain circuit pressure 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 16 Aeroneb Professional Nebulizer System Instruction Manual ADULT PEDIATRIC From ventilator Pediatric T piece Figure 7 Connecting to a pediatric breathing circuit Neonate adapters NEONATE From ventilator Pediatric T piece Figure 8 Connecting to a neonatal breathing circuit Aeroneb Professional Nebulizer System Instruction Manual 17 From ventilator RA D gt aaa Neonate T Piece D Da Figure 9 Alternative neonatal breathing circuit using neonate T pie
21. ng information 38 Aeroneb Professional Nebulizer System Instruction Manual Specifications Physical Nebulizer unit dimensions 45 mm H x 50 mm W x 50 mm D 1 8 in H x 2 0 in W x 2 0 in D Control module dimensions 33 mm H x 75 mm W x 131 mm D 1 3 in H x 2 9 in W x 5 2 in D Control module cable 1 8 m 5 9 ft long AC DC adapter cable 2 1 m 6 7 ft long Nebulizer unit weight 25 g 0 9 oz nebulizer unit and filler cap Control module weight 230 g 8 1 0z including battery and cable Nebulizer unit capacity maximum 10 mL Environmental Operating Maintains specified performance at circuit pressures up to 90 cm 2 and temperatures from 5 C 41 F up to 45 C 113 F Atmospheric pressure 450 to 1100 hPa Humidity 15 to 95 relative humidity Noise level lt 35 dB measured at 0 3 m distance Storage and transport Transient temperature range 20 to 60 C 4 to 140 F Atmospheric pressure 450 to 1100 hPa Humidity 15 to 95 relative humidity Aeroneb Professional Nebulizer System Instruction Manual 39 Performance Flow rate gt 0 2 mL min Average 0 4 mL min Particle size As measured with the Andersen Cascade Impactor Specification Range 1 5 um Average Tested 3 1 um As measured with the Marple 298 Cascade Impactor Specification Range 1 5 6 2 um Average Tested 3 9 um As per EN 13544 1 with a starting dose of 2 mL Aerosol output rate 0 24 mL min Aero
22. ofessional Nebulizer System Instruction Manual Do not use in the presence of devices generating high electromagnetic fields such as magnetic resonance imaging MRI equipment The Aeroneb Pro 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 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 Type BF medical electrical equipment and the device complies with specified safety levels for electrical isolation and leakage current The Aeroneb Pro AC DC adapter has no connection to earth ground because the necessary level of protection is achieved through the use of double insulation 6 Aeroneb Professional Nebulizer Sy
23. oper operation Follow these steps 1 Visually inspect each part of the System for cracks or damage and replace if any defects are visible 2 Pour 1 5 mL of normal saline 0 9 into the nebulizer unit 3 Connect the nebulizer unit to the control module using the control module cable Connect the control module to the AC DC adapter and plug the AC DC adapter into an AC power source 4 Press and release the blue On Off power button and verify that the green 75 Min indicator lights and that aerosol is visible 5 Press the On Off power button again to turn the System off Press and hold the button for at least three seconds Verify that the green 30 Min indicator lights and that aerosol is visible 6 Disconnect the control module from the AC DC adapter and verify that nebulization continues and that the battery status indicator turns off 7 Turn the System off and verify that the 15 Min and 30 Min indicators are off 8 Discard any remaining liquid before patient use Aeroneb Professional Nebulizer System Instruction Manual 27 Cleaning disinfection and sterilization This section describes how to clean disinfect sterilize and inspect Aeroneb Pro system components It is important that Aeroneb Pro device components are cleaned and sterilized prior to first patient use The components are e Nebulizer unit including filler cap e T piece including T piece plug for adult and pediatric e Neonate adapter
24. pted operation of Aeroneb Pro secure both the AC DC adapter cable and the control module cable so they cannot become disconnected during treatment lf 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 14 Aeroneb Professional Nebulizer System Instruction Manual Figure 5 Connecting the AC DC adapter Recharging the Battery To recharge the battery connect the AC DC adapter to the control module and AC power Figure 5 The battery status indicator is amber while charging and green when fully charged Allow a minimum of four hours for the internal battery to fully recharge Note If the control module is placed in long term storage it is recommended that the battery be recharged every 3 months Aeroneb Professional Nebulizer System Instruction Manual 15 Installation for use with a ventilator 1 For adult breathing circuits connect the nebulizer unit with adult T piece into the inspiratory limb of the breathing circuit before the patient Y Figure 6 For pediatric breathing circuits connect the nebulizer unit with pediatric T piece into the inspiratory limb of the breathing circuit before the patient Y Figure 7 For neonatal breathing circuits connect the nebulizer unit with the pediatric T piece and the neonate adapters approximately 30 cm 12 in back from the patient Y Figure 8 Alternatively con
25. r hospital environment If the user of the Aeroneb Pro requires continued operation during power mains interruption it is recommended that the Aeroneb Pro be powered from an uninterruptible power supply or battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note Ut is the a c mains voltage prior to application of the test level Aeroneb Professional Nebulizer System Instruction Manual Guidance and manufacturer s declaration electromagnetic immunity The Aeroneb Pro nebulizer system is intended for use in the electromagnetic environment specified below The customer or the user of the Aeroneb Pro nebulizer system should assure that it is used in such an environment Immunity IEC EN test 60601 Test level Conducted Vrms EN 61000 4 6 150 kHz 80 MHz Radiated RF 3 Vrms EN 61000 4 3 80 MHz to 2 5 GHz Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Aeroneb Pro including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 1 17 VP 1 17 VP 80 MHz to 800 MHz d 2 33 800 MHz to 2 5 GHz Aeroneb Professional Nebulizer Syste
26. s e Control modulet control module cablet and AC DC adaptert e Mounting brackett t Components not to be autoclaved CAUTION Always clean sterilize and disinfect in accordance with current hospital protocols To avoid damage to the nebulizer e Autoclave according to specified directions and temperature given in the Cleaning disinfection and sterilization section of this Instruction Manual only Any deviation from directions given in this Instruction Manual may cause damage to the nebulizer unit and render it inoperable e Do not apply undue pressure to the domed aperture plate in the center of the nebulizer e Do push out the OnQ Aerosol Generator 28 Aeroneb Professional Nebulizer System Instruction Manual Manual Cleaning Cleaning nebulizer unit T pieces and neonate adapters 1 Ensure there is no medication remaining in the device 2 Remove nebulizer unit from T piece Remove filler cap from nebulizer unit 3 Clean all parts with warm water and mild liquid detergent in accordance with current hospital protocols 4 Rinse parts with sterile water 5 Shake excess water from parts and allow parts to fully air dry CAUTION Do not use abrasive or sharp tools to clean the nebulizer unit Automated Washing Cycle The Aeroneb Pro Nebulizer System has been validated with the following automated washing cycles Automated Cycle One Detergent Liquid alkaline cleaner diluted as per man
27. sing and immediately releasing button selects the 15 minute nebulization cycle e Pressing and holding for at least three seconds selects the 30 minute nebulization cycle e Pressing during nebulization turns off power to the nebulizer Battery status e Green Battery fully charged indicator e Amber Battery charging e No light Battery in operation Aeroneb Professional Nebulizer System Instruction Manual 11 Warranty The Aeroneb Pro nebulizer unit is warranted for one year from date of purchase against defects in manufacturing The Aeroneb Pro Control Module and AC DC Adapter are warranted for a period of two years from the date of purchase against defects in manufacturing All warranties are based on typical usage Life of Product As with all active electronic components the Aeroneb Pro nebulizer unit has a defined life In the case of the Aeroneb Pro Controller the life of the controller unit has been validated for use for 1460 doses This is based on a typical product usage profile over a two year period including four treatments per day 50 of the time The life of the Aeroneb Pro nebulizer and components have been validated for use for 730 doses and 26 autoclave treatments based on a typical one year usage profile of four treatments per day and one sterilization per week where the device is assumed to be in service for 50 of the time The user should note that any use in excess of this may result in reduced l
28. sol output 1 08 mL emitted of 2 0 mL dose Residual volume lt 0 1 mL for 3 mL dose Performance may vary depending upon the type of drug and nebulizer unit 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 temperature during normal use 40 Aeroneb Professional Nebulizer System Instruction Manual Representative particle size distribution for Albuterol as per EN 13544 1 is shown below 100 80 60 40 20 Cumulative undersize 0 0 1 1 10 Particle size microns Power Power source can operate from AC DC adapter input 100 to 240 VAC 50 60 Hz output 9 V or internal rechargeable battery 4 8 V nominal output Note The Aeroneb Pro control module is approved for use with Aerogen AC DC adapter AG AP1040 xx Manufacturer Reference FRIWO FW7660M4 09 Power consumption lt 6 5 Watts charging lt 2 0 Watts nebulizing Patient isolation control module circuitry provides 4 kilovolt kV patient isolation and complies with IEC EN 60601 1 Consult your local representative for the order code extension specific to your country Aeroneb Professional Nebulizer System Instruction Manual 41 This page has been intentionally left blank 42 Aeroneb Professional Nebulizer System Instruction Manual Appendix 1 EMC Tabl
29. stem Instruction Manual Warnings e Only use the Aeroneb Pro nebulizer with components specified in the Instructions for Use Use of the Aeroneb Pro nebulizer with components other than those specified in the Instructions for Use may result in increased emissions or decreased immunity of the Aeroneb Pro nebulizer system e Do not use the Aeroneb Pro 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 Pro 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 e Portable and mobile radio frequency communication devices can disrupt medical electrical equipment Refer to appendix 1 for EMC tables as per IEC EN 60601 1 2 Aeroneb Professional Nebulizer System Instruction Manual Symbols The following symbols apply to Aeroneb Pro and appear on the back of the control module and on the packaging Table 1 Aeroneb Pro symbols Meaning OOOO A Attention consult accompanying documents Degree of protection against dripping water PX D Class 11 equipment per IEC EN 60601 1 Type BF equipment per IEC EN 60601 1 On Off power button standby Timer selection to select the 15 minute or 30 minute nebulization cycles KH Control
30. structions regarding activation safe use and disposal of these solutions e Isopropyl 70 e CIDEX e NU CIDEX e OPA e G R 30 Aeroneb Professional Nebulizer System Instruction Manual Sterilization of nebulizer unit T pieces and neonate adapters 1 Disconnect the nebulizer unit from the control module and then remove the nebulizer unit and adapters from the ventilator circuit mask or mouthpiece Disassemble the nebulizer unit and adapters into individual components Remove the filler cap from the nebulizer unit Clean all parts with warm water and mild liquid detergent accordance with current hospital protocols Rinse thoroughly and air dry Check for cracks or damage and replace if any defects are visible Place the disassembled components into appropriate sterilization wrapping CAUTION Do not reassemble parts prior to autoclaving Sterilize components a Steam sterilization can be performed using the following three methods 1 autoclave wrapped parts using steam sterilization pre vacuum cycle a minimum of 134 C 270 275 for 3 5 minutes with drying cycle 134 C wrapped cycle ii autoclave wrapped parts using steam sterilization pre vacuum cycle a minimum of 121 C 250 F for 20 minutes with drying cycle 121 C wrapped cycle iii autoclave wrapped parts using steam Sterilization pre vacuum cycle a minimum of 134 C 270 275
31. th standard ventilator circuits and mechanical ventilators It operates without changing patient ventilator parameters and can be refilled without interrupting ventilation The 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 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 Aeroneb Professional Nebulizer System Instruction Manual System description The Aeroneb Professional Nebulizer System Figure 1 includes the following components nebulizer unit Aerosol Generator and filler cap T piece adult with plug control module control module cable AC DC adapter and mounting brackets Filler Cap He 1 Nebulizer unit with filler cap 2 T piece adult with plug Hy ND a 3 Control module 4 Control Module Cable AC DC adapter 6 Universal mounting bracket ya 7 Equipment mount adapter Figure 1 Aeroneb Pro 2 Aeroneb Professional Nebulizer System Instruction Manual
32. uch as re orientating or relocating the Aeroneb Pro nebulizer system P Over the frequency range 150 kHz 80 MHz field strengths should be less than 3 V m Aeroneb Professional Nebulizer System Instruction Manual Manufacturer Aerogen Limited Galway Business Park Dangan Galway Ireland Customer Service International Telephone 353 91 540400 US Telephone 1 866 4AEROGEN 1 866 423 7643 www aerogen com Part No AG AP1080 UK MW Rev L 2013 Aerogen Lid Aerogen Manufacturing no 30 012 Rev L
33. ufacturers instruction Water Quality Mains water Method 1 Load the components in the automated washer 2 Pre rinse the components for minutes 3 Clean the components with liquid alkaline cleaner at 55 C 131 F for 10 minutes 4 Rinse for 1 minute 5 Rinse using thermal disinfection cycle at 93 C 199 4 F for 10 minutes Aeroneb Professional Nebulizer System Instruction Manual 29 Automated Cycle Two Detergent following cycle was validated without the use of a detergent Water Quality Mains water Method Load the components in the automated washer Wash components for 10 minutes at 91 C 195 8 F Drain the machine for 40 seconds Rinse at 90 C 194 F for 1 minute Drain the machine for 40 seconds Rinse at 90 C 194 F for 1 minute Drain the machine for 40 seconds Dry at 90 C 194 F for 15 minutes Oo ot Oe Ol are ae Disinfection of nebulizer unit T pieces and neonate adapters 1 Follow steps 1 through 3 in manual cleaning section on page 29 2 Completely immerse parts in appropriate disinfecting agent in accordance with current hospital protocols and disinfectant agent manufacturer guidelines NOTE Aerogen approves the following disinfection solutions for use with its Aeroneb Pro Nebulization System regarding material compatibility With respect to microbiological effectiveness please ask the manufacturer Refer to the product labeling for specific in
34. vent electromagnetic interference by maintaining a minimum distance between port and mobile RF communications equipment transmitters and the Aeroneb Pro nebulizer system as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency output power of of transmitter transmitter m 150 kHz to 80 MHz to 800 MHz to 80 MHz 800 MHz 2 5 GHz d 1 17 d 1 17 VP 2 33 VP 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 Aeroneb Professional Nebulizer System Instruction Manual Guidance and manufacturer s declaration electromagnetic immunity The Aeroneb Pro nebulizer system is intended for use in the electromagnetic environment specified below The customer or the user of the Aeroneb Pro nebulizer system should assure that it is used in such an environment Immunity test Electrostatic discharge ESD
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