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Aeroneb

®

Solo System Instruction Manual

Warnings

•

Only use the Aeroneb

®

Solo nebulizer with components

specified in the Instructions for Use. Use of the

Aeroneb

®

Solo nebulizer with components other than

those specified in the Instructions for Use may result

in increased emissions or decreased immunity of the

Aeroneb

®

Solo nebulizer system.

•

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.

•

The Aeroneb

®

Solo 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 and mobile radio frequency (“RF”)

communication devices can disrupt medical electrical

equipment.

Refer to Appendix 1 for EMC Tables as per IEC/EN 60601-1-2

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Содержание Solo System

Страница 1: ...Rx Only US 8 30 mins Symbols for Page 8 and 9 Instruction Manual...

Страница 2: ......

Страница 3: ...Part Number AG AS3050 EN Rev J 2011 Aerogen Ltd Instruction Manual Aeroneb Solo System...

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

Страница 5: ...13 Assembly and Installation 14 Recharging the Battery 21 Installation for use with a ventilator 21 Installation for use with a mask 25 Installation for use with a mouthpiece 26 Adding medication 27...

Страница 6: ...ing circuit 22 Figure 9 Connecting to a neonate breathing circuit 22 Figure 10 Alternative neonatal breathing circuit using neonate T piece 23 Figure 11 Control module and universal mounting bracket V...

Страница 7: ...ontinuous nebulization that incorporates Aerogen s OnQ Aerosol Generator The Aeroneb Solo nebulizer is designed to operate in line with standard ventilator circuits and mechanical ventilators It opera...

Страница 8: ...e control cable AC DC adapter and mounting brackets Pedatric neonate adapters and continuous nebulization tube set are sold separately 1 Nebulizer unit with plug 2 T piece Adult 30 Min Continuous Mode...

Страница 9: ...te and converted into an aerosol 2 The T piece securely connects the nebulizer unit into the breathing circuit The T piece connections are standard male and female 22mm conical ports and connect to st...

Страница 10: ...System Instruction Manual 7 A universal mounting bracket clamps the control module to standard IV poles and medical rail systems 8 An equipment mount adapter mounts the control module on standard equ...

Страница 11: ...orrect 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 connecte...

Страница 12: ...ush out the OnQ 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 Do not use the Aeroneb Solo nebulizer with the reu...

Страница 13: ...ements 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...

Страница 14: ...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 The Aeroneb Solo...

Страница 15: ...ere 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 equip...

Страница 16: ...restricts this device to sale by or on the order of a physician US Classified by TUV with respect to electric shock fire and mechanical hazards This device complies with the requirements of the Medic...

Страница 17: ...r Timer Selection Battery Status Indicator 9V D C Input Control Module Cable Input 30 Min Continuous Mode On Off Timer International Controller Fault Indicator 30 Min Indicator Continuous Mode Indicat...

Страница 18: ...on Nebulizer unit 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 erro...

Страница 19: ...purchase All warranties are based on typical usage detailed below Life of Product As with all active electronic components the Aeroneb Solo nebulizer unit has a defined life In the case of Aeroneb So...

Страница 20: ...ect 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 2 Insert the nebulizer and the T piece into the breat...

Страница 21: ...ction Manual 15 30 8 Figure 4 Connecting control module and nebulizer unit 4 Connect the Aeroneb Pro X AC DC adapter to the Aeroneb Pro X controller as shown in Figure 5 30 8 Figure 5 Connecting the A...

Страница 22: ...omatically switch to battery operation Note Allow a minimum of eight hours for the internal battery to fully recharge Note To ensure uninterrupted operation of Aeroneb Solo secure both the AC DC adapt...

Страница 23: ...2 Remove the syringe cap 1 from the medication filled syringe 3 Attach the syringe end of the tubing 5 onto the syringe 2 4 Prime the tubing 6 until the medication reaches end of tubing Point A NOTE T...

Страница 24: ...nto the Aeroneb Solo nebulizer during continuous nebulization is 0 2mL per minute or 12mL per hour This is based on the manufacturers specification for the lowest acceptable nebulizer flow rate For di...

Страница 25: ...there are any signs of cracks damage or foreign matter Do not attempt to connect the system to any nebulizer other than the Aeroneb Solo Do not attempt to connect the tubing or syringe to any non res...

Страница 26: ...bing 6 is safely orientated to prevent a trip hazard 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 nebulize...

Страница 27: ...piece into the inspiratory limb of the breathing circuit before the patient Y Figure 7 For pediatric breathing circuits connect the nebulizer unit with pediatric T piece into the inspiratory limb of t...

Страница 28: ...t T piece Figure 7 Connecting to an adult breathing circuit Pediatric T piece Y From ventilator PEDIATRIC Figure 8 Connecting to a pediatric breathing circuit Neonate adapters Pediatric T piece Y From...

Страница 29: ...ing 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...

Страница 30: ...System Instruction Manual Figure 11 Control module and universal mounting bracket Vertical Figure 12 Control module and universal mounting bracket Horizontal Standard equipment mount Figure 13 Equipme...

Страница 31: ...es representative for ordering infomation 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...

Страница 32: ...d 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 firml...

Страница 33: ...ler port of the nebulizer Figure 16 3 Close the plug CAUTION To avoid damage to the nebulizer unit do not use a syringe with needle The maximum capacity of the nebulizer unit is 6 mL Figure 16 Filling...

Страница 34: ...the nebulizer back to the medication reservoir to make sure the medication tube is connected to the correct source 2 To start a continuous nebulization cycle connect the continuous nebulization tube s...

Страница 35: ...17 Starting and stopping nebulization 30 Min Indicator Continuous Mode Indicator On Off Power Button Press and Release to select 30 min Press and hold for three seconds to select Continuous Mode 30 M...

Страница 36: ...ontrol 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 30 Min indicator LED illuminates and th...

Страница 37: ...ulizer follow these steps 1 Transfer 0 5 mL of normal saline 0 9 or intended drug into the Aeroneb Solo medication cup 2 Turn on the nebulizer 3 Using a stop watch measure the length of time it takes...

Страница 38: ...dampened with mild detergent and water 2 Check for exposed wiring damaged connectors or other defects and replace control module if any are visible 3 Visually inspect for damage and replace the contr...

Страница 39: ...y this The 30 Min indicator flashes during nebulization Battery power is low Recharge battery see Recharging the battery Battery will not recharge Control module is connected to the AC DC adapter and...

Страница 40: ...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 ad...

Страница 41: ...harge 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 unit See Warranty an...

Страница 42: ...l AG AS3000 XX Aeroneb Solo Convenience Kit Pack of 5 Aeroneb Solo nebulizers Adult T pieces with silicone plugs AG AS3300 Aeroneb Solo Convenience Kit Pack of 10 Aeroneb Solo nebulizers Adult T piece...

Страница 43: ...1065 Disposable Mask Kit International Pack of 5 22F 22M 15F 22F 22F vented AG AS1075 Disposable Vented Elbow Pack of 5 22F 22F vented AG AS1055 Continuous Nebulization Tubset Tubing Pack of 5 AG AS30...

Страница 44: ...t 13 5 g 0 5 oz nebulizer unit and plug Control module weight 230 g 8 1 oz including battery and cable Nebulizer unit capacity Maximum 6 mL Environmental Operating Maintains specified performance at c...

Страница 45: ...t Aerogen or drug supplier The temperature of the medication will not rise more than 10 C 18 F above ambient during normal use Representative particle size distribution for Albuterol as per EN 13544 1...

Страница 46: ...This page has been intentionally left blank...

Страница 47: ...Aeroneb Solo System Instruction Manual 41 Appendix 1 EMC tables...

Страница 48: ...This page has been intentionally left blank...

Страница 49: ...tic 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 cau...

Страница 50: ...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...

Страница 51: ...ischarge ESD IEC 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 l...

Страница 52: ...in Ut for 25 cycles 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 Solo nebulizer system requires continued o...

Страница 53: ...e RF communications equipment should be used no closer to any part of the Aeroneb Solo nebulizer system including cables than the recommended separation distance calculated from the equation applicabl...

Страница 54: ...cast 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...

Страница 55: ......

Страница 56: ...ted 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 AS3050 EN Manufacturing no 3...

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