AeronebLab User`s Manual - Kent Scientific Corporation
Contents
1. Ae j nek D0 Instruction Manual Ae fone b 6 FOR PRE CLINICAL USE ONLY NOT F d 9 2004 Aerogen Inc Part No AG AL1010 Rev C Aerogen Table of Contents Introdu EEN 3 System CESCHIPUON ass ENEE 4 MY IMG S ee 5 CAMIONS E 5 Electromagnetic Susceptibility cccccccceessssseseeseeeees 5 SV IMDOIS Svea acne arid Beeson Eed 6 Controls and indicators 7 Assembly and installation 8 Adding MTS e WEE 9 F ARGIONAl TES Re Re Mn nn tra net 10 OTT nale 11 TROUDIES eet e Le a A 12 Order NUMBER te E EE E ks ng t tet 12 HSDEGHICAHONS sh En uen nn er nr 13 se RS SNS Rte nn eine 13 ek gei Los nn end 13 En Leid e 13 Se 13 List of Figures Figure 1 Aeroneb Lab 4 Figure 2 Aeroneb Lab controls and indicators 7 Figure 3 Connecting filler cap to nebulizer unit 8 Figure 4 Connecting nebulizer unit to control module 8 Figure 5 Filling the nebulizer unit 9 Figure 6 Maximum fill indication point 9 List of Tables Table 1 Aeroneb Lab System svmbole 6 Table 2 Aeroneb Lab control indicator functions 7 Table 3 Aeroneb Lab Troublesbooting 12 Table 4 Aeroneb Lab parts list 12 Aeroneb Lab Nebulizer System Instruction Manual introduction The Aeroneb Lab Nebulizer System is a nebul2. Operating Maintains specified performance at temperatures up to 45 C 113 F Atmospheric pressure 450 to 1100 hPa Humidity 15 to 95 relative humidity Temperature 5 to 40 C Storage and transport Temperature range 20 to 60 C 4 to 140 F Atmospheric pressure 450 to 1100 hPa Humidity 15 to 95 relative humidity Performance Standard Volumetric Mean Diameter VMD Nebulizer Unit Flow rate gt 0 3 mL min Particle size VMD between 4 0 um and 6 0 um Residual volume lt 0 2 mL Small Volumetric Mean Diameter VMD Nebulizer Unit Flow rate gt 0 1 mL min Particle size VMD between 2 5 um and 4 0 um Residual volume lt 0 2 mL Power Power source can operate from AC DC adapter input 100 to 240VAC 50 60Hz output 9V OR an external 9V DC power supply Power consumption lt 2 57 Watts Aeroneb Lab Nebulizer System Instruction Manual 13 Manufacturer Aerogen Ireland Limited Galway Business Park Dangan Galway Ireland Customer Service Telephone 353 91 502550 Aerogen Aeroneb Lab Nebulizer System Instruction Manual 14
3. XXXX Serial number where YY is the year of manufacture and XXXX is the p serial number Attention consult accompanying documents Degree of protection against dripping water Class II equipment per IEC 61010 1 9 Output L gt Aeroneb Lab Nebulizer System Instruction Manual 6 Control Module Output A C voltage Control Module Input D C voltage Fragile handle with care Storage temperature limitations 20 C to 60 C Keep dry Compliance with the European Directives 89 336 EEC EMC and 73 23 EEC Low Voltage Controls and indicators Aeroneb FOR PRE CLINICAL USE ONLY NOT FOR HUMAN USE oO Figure 2 Aeroneb Lab controls and indicators Table 2 Aeroneb Lab control indicator functions Control indicator Amber Warning LED When illuminated indicates nebulizer is disconnected or faulty connection Green Power delivery LED When illuminated indicates that power is supplied and that the unit is aerosolizing Aeroneb Lab Nebulizer System Instruction Manual 7 Assembly and installation 1 Clean the nebulizer unit as described in the maintenance section of this manual prior to first use and between uses 2 Insert the filler cap into the opening on the nebulizer unit Figure 3 Connecting filler cap to nebulizer unit 3 Connect the nebulizer unit to the control module using the control module cable Figure 4 Connecting nebulizer unit to contr
4. ave wrapped parts using steam sterilization pre vacuum cycle 132 C 135 C 270 F 275 F for 3 4 minutes with drying cycle 7 Prior to next use check for cracks or damage and replace if any defects are visible 8 Prior to next use perform a functional test as described in this manual NOTE It is recommended that the device be cleaned after each use to ensure proper nebulization Control module AC DC adapter and cable 1 Wipe clean with a damp cloth 2 Do not autoclave 3 Check for exposed wiring damaged connectors or other defects and replace if any are visible 4 Perform functional test as described in this manual before re use Aeroneb Lab Nebulizer System Instruction Manual 11 Troubleshooting Table 3 Aeroneb Lab Troubleshooting If this happens It could mean Try this The indicator lights but No liquid in nebulizer unit Refill liquid through filler cap in the aerosol is not visible nebulizer unit see Adding Liquid Nebulizer unit has not been properly Clean nebulizer unit see cleaned Maintenance It may be time to replace the nebulizer Refer to Aeroneb Lab parts list unit Indicator does not light There is no power to the system Verify that AC DC adapter is securely attached to control module Longer than expected Nebulizer unit has not been properly Clean nebulizer see treatment time cleaned Maintenance The nebulizer unit may need Refer to Aeroneb Lab
5. formulation or chemical entity while maintaining the integrity of this entity can only be determined through direct testing and is the responsibility of the device user Cautions To avoid mechanical or electrical damage do not drop the nebulizer unit or the control module Disconnect nebulizer unit from control module before cleaning Do not immerse in water or autoclave the control module cables or AC DC adapter Use only with components specified by Aerogen 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 Aerogen representative Do not use or store outside of specified environmental conditions Electromagnetic Susceptibility This device meets the requirements for Electromagnetic Compatibility as defined by European Directive 89 336 EEC relating to Electromagnetic Compatibility 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 the equipment Aeroneb Lab Nebulizer System Instruction Manual 5 Symbols The following symbols apply to the Aeroneb Lab and appear on the back of the control module and on the packaging Table 1 Aeroneb Lab System symbols AL YY
6. izer system that is intended to aerosolize solutions for pre clinical testing It is not intended for use with humans The Aeroneb Lab Control module operates from an AC DC adapter with the option of being directly powered from any automated test equipment providing 9 volts DC This can enable the timing of aerosolization based on programmed criteria The Aeroneb Lab is a latex free nebulizer system that incorporates Aerogen s proprietary OnQ Aerosol Generator for aerosolization Note The Aeroneb Lab utilizing OnQ Aerosol Generator technology has been utilized to aerosolize a broad range of liquid formulations including suspensions and proteins However the ability to effectively aerosolize a novel formulation or chemical entity can only be determined through direct testing and is the responsibility of the device user Aeroneb Lab Nebulizer System Instruction Manual 3 System description The Aeroneb Lab Figure 1 includes the following components Nebulizer unit containing the OnQ Aerosol Generator and filler cap control module control module cable AC DC adapter and DC cable Filler Cap 1 Nebulizer Unit Including Filler Cap 3 Control Module Cable 4 AC DC Adapter mg 5 DC Cable Figure 1 Aeroneb Lab The nebulizer unit holds up to 10mL of liquid The nebulizer unit is translucent to allow visual monitoring of liquid levels and aerosolization Within the nebulizer unit is an OnQ Aeros
7. ol Generator which consists of a domed aperture plate with precision formed holes that control the size of the aerosol droplets and a vibrational element whose micro pumping action aerosolizes liquid Gravity brings the liquid in contact with the aerosol generator where the liquid is drawn through the aperture plate and converted into an aerosol The control module can be powered by applying a 9V DC signal from an external DC voltage source to the DC cable this cable is then connected to the control module Alternatively power can be supplied from the AC DC adapter The control module also includes a cable that attaches to the nebulizer unit The control module includes visual indicators that display power on status and fault condition status Aeroneb Lab Nebulizer System Instruction Manual 4 Warnings Read and study all instructions before using the Aeroneb Lab Only trained personnel should operate the device For pre clinical use only It is not intended for use with humans Do not use in the presence of a flammable anesthetic mixture combined with air or with oxygen or nitrous oxide To avoid the risk of fire do not use in the presence of flammable substances Assemble and perform a functional test according to the instructions in this manual before use If this equipment is not used in a manner specified in this manual the protection provided by the equipment may be impaired The ability to effectively aerosolize a novel
8. ol module NOTE To ensure uninterrupted operation of the Aeroneb Lab secure power and control module cables so they cannot become disconnected during treatment Ensure all cables are routed safely NOTE To ensure proper nebulization maintain the nebulizer in an upright position 4 When powering the control module using the DC cable e Insert one end of the DC cable into the control module e Connect the other end to a 9V DC power source ensuring o The wire with the red sheath is connected to a positive terminal o The black wire is connected to a negative terminal Aeroneb Lab Nebulizer System Instruction Manual 8 5 When powering the control module using the AC DC adapter e Insert the adapter jack into the control module e Plug the adapter plug into wall socket mains Adding Liguid 1 Open the filler cap tab on the nebulizer unit 2 Use a prefilled ampoule or syringe to add liguid into the filler port of the nebulizer Figure 5 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 6 The underside of the filler cap represents maximum fill indication point jak 4 CA gt E ila lt MAXIMUM INDICATION FILL POINT Figure 6 Maximum fill indication point Note Liquid can also be added in this manner du
9. parts list replacement If these suggestions do not correct the problem discontinue use of any device that is or appears to be damaged or not operating properly and contact your local Aeroneb Lab product representative Order Numbers Table 4 lists the Aeroneb Lab order numbers see Figure 1 for pictures Table 4 Aeroneb Lab parts list Description Order Number Aeroneb Lab Control Module includes DC cable AG AL7500 Aeroneb Lab Control Module includes AC DC adapter AG AL7000 Aeroneb Lab Nebuliser Unit Autoclavable Standard 4 0 AG AL1000 6 0 VMD particle size Aeroneb Lab Nebulizer Unit Autoclavable Small 2 5 4 0 AG AL1100 VMD particle size Control Module detachable cable replaceable AG AP1085 Aeroneb Lab Instruction Manual AG AL1010 Consult your local representative for the order code extension specific to your country and for pricing Aeroneb Lab Nebulizer System Instruction Manual 12 Specifications Physical Nebulizer unit dimensions 45 mm H x 50 mm W x 50 mm D 1 77 in H x 1 97 in W x 1 97 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 Nebulizer unit weight 25 g 0 88 oz nebulizer unit and filler cap Control module weight 178 g 6 3 oz including cable Nebulizer unit capacity maximum 10mL Nebulizer and components are latex free Environmental
10. ring nebulization This does not interrupt nebulization Aeroneb Lab Nebulizer System Instruction Manual 9 Functional test To perform a functional test of the Aeroneb Lab before each use or to verify proper operation follow these steps Visually inspect the device for cracks or damage and replace if any defects are visible Pour 0 5 mL of sterile water or normal saline into the nebulizer unit Connect the nebulizer unit to the control module connect the control module to the power source Verify that the green power light is on Ensure that aerosol is visible Disconnect power to turn the system off St Ors ge e Discard any remaining liguid before next use Aeroneb Lab Nebulizer System Instruction Manual 10 Maintenance This section describes how to clean sterilize and inspect Aeroneb Lab components Nebulizer unit including filler cap To clean unit between uses for the same subject 1 Disconnect the control module and cable from the nebulizer unit 2 Remove the filler cap from the nebulizer unit 3 Clean parts with warm water and mild liquid detergent Rinse thoroughly and air dry CAUTION Do not use abrasive or sharp tools to clean the nebulizer unit 4 Check for cracks or damage and replace if any defects are visible 5 Place the disassembled components into appropriate sterilization wrapping CAUTION Do not reassemble parts prior to autoclaving 6 To sterilize autocl
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