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Aerogen

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 
for use in all establishments, including domestic 
establishments and those directly connected to 
the public low voltage power supply network that 
supplies buildings used for domestic purposes.

Harmonic emissions
IEC 61000 3 2

Compliant

Voltage fluctuations/
flicker emissions
IEC 61000 3 3

Compliant

Recommended separation distances between portable and mobile RF communication 
equipment and the Aeroneb Solo nebulizer system  

This Aeroneb Solo 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 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.

Rated 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 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.

Содержание Aeroneb Solo

Страница 1: ...www aerogen com Aeroneb Solo System Instruction Manual...

Страница 2: ......

Страница 3: ...embly Installation 6 Installation For Use With A Ventilator 10 Installation For Use Off Ventilator 12 Nebulization Modes 15 Aeroneb Solo Aerosol Flow Rate Calculation 19 Troubleshooting 20 Parts List...

Страница 4: ...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...

Страница 5: ...olo System 1 Aeroneb Solo With Plug 2 T Piece Adult 3 Aeroneb Pro X Controller 4 Controller Cable 5 AC DC Adapter 6 Universal Mounting Bracket Equipment Mount Adapter 7 Continuous Nebulization Tube Se...

Страница 6: ...onsult 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 use beyond de...

Страница 7: ...late in the center of the nebulizer Do not push out the vibrating mesh aerosol generator Do not use a syringe with a needle to add medication Do not attempt to clean the nebulizer Do not use or store...

Страница 8: ...n 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 neb...

Страница 9: ...the Aeroneb Solo secure both the AC DC adapter cable and the controller cable so they cannot become disconnected during treatment If clips are available on patient circuits run the cables through the...

Страница 10: ...y lit Aeroneb Solo nebulizer disconnected from Aeroneb Pro X controller Amber flashing Aeroneb Pro X drive voltage error On Off Power Button To operate in 30 minute mode press the On Off button once T...

Страница 11: ...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 Do not immerse or autoclave the Aerone...

Страница 12: ...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 c...

Страница 13: ...facturer 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 f...

Страница 14: ...ing 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...

Страница 15: ...en 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...

Страница 16: ...correct operation 7 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 steri...

Страница 17: ...ication 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...

Страница 18: ...emove the syringe cap from the medication filled syringe 3 Attach the syringe end of the tubing onto the syringe 4 Prime the tubing until the medication reaches end of tubing Point A Note The tubing p...

Страница 19: ...ebulizer 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 ensu...

Страница 20: ...dicator light illuminates and that aerosol is visible 5 Disconnect the AC DC adapter from the controller and verify that nebulization continues and that the battery status indicator turns off 6 Power...

Страница 21: ...ebulizer 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 from the start of...

Страница 22: ...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 yo...

Страница 23: ...nnected 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...

Страница 24: ...eroneb Solo Nebulizers Pack of 10 AG AS3200 Disposable Adult T piece Pack of 10 22M 22F 22M AG AS3010 Disposable Pediatric T piece Pack of 10 15M 22F 15M AG AS3020 Disposable Pediatric T piece Adapter...

Страница 25: ...e 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 Moun...

Страница 26: ...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 In the case of Aeroneb Solo the life of...

Страница 27: ...s up to 90 cm H2 O and temperatures from 5 C 41 F up to 45 C 113 F Atmospheric Pressure 450 to 1100 mbars Humidity 15 to 95 relative humidity Noise Level 35 dB measured at 0 3 m distance Storage Trans...

Страница 28: ...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 correspond to confidence inter...

Страница 29: ...emask 0 Adult 73 5 61 6 N A 70 7 52 3 Pediatric 54 5 45 6 N A 52 9 42 5 2 Adult 73 8 59 2 44 0 37 7 65 4 45 3 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...

Страница 30: ...ntained in package IPX1 Degree of protection against dripping water Rx Only Federal US Law restricts this device to sale by or on the order of a physician Class II equipment per IEC EN 60601 1 Certifi...

Страница 31: ...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 protect...

Страница 32: ...eb Solo nebulizer system This Aeroneb Solo nebulizer system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Aero...

Страница 33: ...0 4 5 1 kV line s to line s 2 kV Line s to earth 1 kV line s to line s 2 kV Line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interr...

Страница 34: ...engths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment...

Страница 35: ......

Страница 36: ...Manufacturer Aerogen Ltd Galway Business Park Dangan Galway Ireland 2014 Aerogen Ltd Part No AG AS3050 US P N 30 674 Rev D INTL 353 91 540 400 U S 1 886 423 7643 PHONE www aerogen com...

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