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Aeroneb

®

Professional Nebulizer System Instruction Manual

43

Appendix 1

EMC Tables

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Содержание Aeroneb Pro

Страница 1: ...Instruction Manual ...

Страница 2: ... ...

Страница 3: ...Aeroneb Professional Nebulizer System Instruction Manual ...

Страница 4: ... This page has been intentionally left blank ...

Страница 5: ...f Product 12 Assembly and Installation 13 Recharging the Battery 15 Installation for use with a ventilator 16 Installation for use with a mask 20 Installation for use with a mouthpiece 22 Adding medication 23 Nebulization 25 Functional test 27 Cleaning disinfection and sterilization 28 Troubleshooting 34 Order numbers 37 Specifications 39 Physical 39 Environmental 39 Performance 40 Appendix 1 EMC ...

Страница 6: ...cuit 17 Figure 9 Alternative neonatal breathing circuit using neonate T piece 18 Figure 10 Control module and universal mounting bracket vertical 19 Figure 11 Control module and universal mounting bracket horizontal 19 Figure 12 Equipment mount adapter 19 Figure 13 Connecting to a mask 21 Figure 14 Connecting to a mouthpiece 22 Figure 15 Filling the nebulizer unit with a pre filled ampoule 23 Figu...

Страница 7: ...y It is designed to operate in line with 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...

Страница 8: ...ts nebulizer unit Aerosol Generator and filler cap T piece adult with plug control module control module cable AC DC adapter and mounting brackets Figure 1 Aeroneb Pro Filler Cap 1 Nebulizer unit with filler cap 2 T piece adult with plug 3 Control module 5 AC DC adapter 7 Equipment mount adapter 6 Universal mounting bracket 4 Control Module Cable T piece plug ...

Страница 9: ...rawn through the aperture plate and converted into an aerosol 2 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 3 4 5 The control module can operate from the AC DC adapter or the internal rechargeable batt...

Страница 10: ...structions 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 suitab...

Страница 11: ... of the nebulizer Do not push out the Aerogen Vibronic Aerosol Generator Do not use a syringe with a needle to add medication Do not use abrasive or sharp tools to 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 ne...

Страница 12: ...es 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 ins...

Страница 13: ...em 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 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 Portable...

Страница 14: ...P YYXXXX Serial number where YY is the year of manufacture and XXXX is the serial number Attention consult accompanying documents Degree of protection against dripping water Class II 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 Control Module Input DC voltage Control Module Out...

Страница 15: ...andle 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 Quantity Number of units contained in package 60 C 20 C ...

Страница 16: ...ystem Instruction Manual Controls and indicators Figure 2 Aeroneb Pro controls and indicators Fault Indicator On Off Power Timer Selection Battery Status Indicator 9V D C Input Control Module Cable Input 15 Min Indicator 30 Min Indicator ...

Страница 17: ... 30 minute nebulization cycle on Green flashing Low battery power Nebulizer unit automatically powers off after 30 minutes have elapsed Fault indicator Amber Faulty electrical connection On Off power button Pressing and immediately releasing selects the 15 minute nebulization cycle Pressing and holding for at least three seconds selects the 30 minute nebulization cycle Pressing during nebulization...

Страница 18: ...ulizer 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 ...

Страница 19: ...anual 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 3 Insert the filler cap into the opening on the nebulizer unit 4 Connect the nebulizer unit to the T piece by pushing the nebulizer unit firmly onto the T piece Figure 3 Figure 3 Connecting nebuli...

Страница 20: ... 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 uninterrupted operation of Aeroneb Pro secure both the AC DC adapter cable and the control modul...

Страница 21: ... 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 ...

Страница 22: ...e 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...

Страница 23: ...ual 17 Figure 6 Connecting to an adult breathing circuit Figure 7 Connecting to a pediatric breathing circuit Neonate adapters Pediatric T piece From ventilator Y NEONATE Adult T piece From ventilator ADULT Y PEDIATRIC Y Pediatric T piece From ventilator ...

Страница 24: ...rting 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 mod...

Страница 25: ...ulizer System Instruction Manual 19 Figure 10 Control module and universal mounting bracket vertical Figure 11 Control module and universal mounting bracket horizontal Standard equipment mount Figure 12 Equipment mount adapter ...

Страница 26: ...s 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 ...

Страница 27: ...Aeroneb Professional Nebulizer System Instruction Manual 21 Patient Upright Patient Reclined Figure 13 Connecting to a mask Vented Elbow Facemask Elbow ...

Страница 28: ...ce 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 T piece 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 ...

Страница 29: ...ON 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 ...

Страница 30: ...24 Aeroneb Professional Nebulizer System Instruction Manual Figure 16 Maximum fill indication point Max fill indication point ...

Страница 31: ...ebulization 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 3 To stop the nebulizer at any time press the On Off power button The indicator turns off to indicate th...

Страница 32: ...al Nebulizer System Instruction Manual Figure 17 Starting and stopping nebulization On Off Power Button Press and release to select 15 min Press and hold for three seconds to select 30 min 15 Min Indicator 30 Min Indicator ...

Страница 33: ...ble 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 15 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 a...

Страница 34: ...module control module cable and AC DC adapter Mounting bracket Components not to be autoclaved CAUTION Always clean sterilize and disinfect in accordance with current hospital protocols To avoid damage to the nebulizer Autoclave according to specified directions and temperature given in the Cleaning disinfection and sterilization section of this Instruction Manual only Any deviation from direction...

Страница 35: ...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 manufacturers instruction Water Quality Mains water Method 1 Load the components in the automate...

Страница 36: ... for 15 minutes 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 Sys...

Страница 37: ... or damage and replace if any defects are visible 6 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 i autoclave wrapped parts using steam sterilization pre vacuum cycle a minimum of 134 C 270 F 275 F for 3 5 minutes with drying...

Страница 38: ...s plasma place wrapped parts in a STERRAD System and use the long cycle CAUTION Users should refer to the product labelling for the STERRAD 100S Sterilization System for specific instructions regarding its proper operation Prior to next use i 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...

Страница 39: ... 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 module 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 ...

Страница 40: ...r 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 ne...

Страница 41: ...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 battery is depleted Recharge battery see Recharging the battery The fault i...

Страница 42: ...er 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 and a volume greater than 3 mL was added to the nebulizer unit Run an ...

Страница 43: ...ow 15 mm Female AG AP1020 Neonate T Piece with silicone plug Pack of 5 12 mm Male 22 mm Female Elbow 12 mm Female Fits Fisher Paykel Neonate breathing circuit AG AP1035 Neonate T Piece with silicone plug Pack of 5 10 mm Female 22 mm Female Elbow 10 mm Male AG AP1036 Pediatric T Piece Neonate Adapter Kit Pack of 5 15 mm Male 22 mm Female Elbow 15 mm Female Silicone Plug Adapters 15 mm Male 10 mm OD...

Страница 44: ...ational Pack of 5 Kits 22 mm female 22 mm Male Elbow 22 mm female 22 mm Female Vented Elbow AG AP1075 Nebulizer Filler Cap Pack of 5 AG AP1030 AC DC Adapter AG AP1040 XX Control Module AG AP1050 XX Control Module Cable AG AP1085 Universal Mounting Bracket AG AP1060 Equipment Mount Adapter AG AP1070 Instruction Manual AG AP1080 XX consult your local representative for the order code extension speci...

Страница 45: ...ight 25 g 0 9 oz nebulizer unit and filler cap Control module weight 230 g 8 1 oz including battery and cable Nebulizer unit capacity maximum 10 mL Environmental Operating Maintains specified performance at circuit pressures up to 90 cm H2O 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 35 dB measured at 0 3 m di...

Страница 46: ...ctor Specification Range 1 5 6 2 µm Average Tested 3 9 µm As per EN 13544 1 with a starting dose of 2 mL Aerosol output rate 0 24 mL min Aerosol output 1 08 mL emitted of 2 0 mL dose Residual volume 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 ...

Страница 47: ...minal 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 6 5 Watts charging 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 ...

Страница 48: ...42 Aeroneb Professional Nebulizer System Instruction Manual This page has been intentionally left blank ...

Страница 49: ...Aeroneb Professional Nebulizer System Instruction Manual 43 Appendix 1 EMC Tables ...

Страница 50: ...iance Electromagnetic environment guidance RF Emissions CISPR 11 Group 1 The Aeroneb Pro 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 Pro nebulizer system is suitable for use in all establishments including domestic establis...

Страница 51: ... maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 33 P 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 ...

Страница 52: ...rostatic discharge ESD 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 EN 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should...

Страница 53: ...s 5 Ut 95 dip in Ut for 5 sec Mains power quality should be that of a typical commercial or 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 50 60 Hz Magnetic field EN 61000 4 8 3 A m 3 A m Power frequency magnetic fields ...

Страница 54: ...ent Immunity test IEC EN 60601 Test level Compliance level Electromagnetic environment guidance Conducted RF EN 61000 4 6 Radiated RF EN 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 Vrms 80 MHz to 2 5 GHz 3 V 3 V 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 appl...

Страница 55: ...nsmitters as determined by an electromagnetic site survey ª should be less than the compliance level in each frequency range b 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 ...

Страница 56: ...e 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 such as re orientating ...

Страница 57: ......

Страница 58: ...Limited Galway Business Park Dangan Galway Ireland Customer Service International Telephone 353 91 540400 US Telephone 1 866 423 7643 www aerogen com Part No AG AP1080 UK Rev M 2014 Aerogen Ltd Manufacturing no 30 012 Rev M ...

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