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The device is intended for use in the electromagnetic environment 

specified below. The customer or the user of the device should assure that 

it is used in such an environment.

18

Guidance and manufacturer’s declaration – electromagnetic immunity – for 

device that is not LIFE- SUPPORTING.

Guidance and manufacturer’s declaration – electromagnetic immunity

 

Immunity 

test

IEC60601 

test level

Compliance 

level

Electromagnetic environment –

guidance

Conducted 

RF

IEC 61000

-4-6

Radiated 

RF  IEC 

61000-4-3

3 V/m

150 kHz 

to 80

MHz

3 V/m

80 MHz to 

2.5 GHz

  3V rms

  3V/m

Portable and mobile RF communica-

tions equipment should be used no 

closer to any part of this device, 

including cables, than the recommend-

ed separation distance calculated from 

the equation applicable to the 

frequency of the transmitter.  
Recommended separation distance

 

 

 

80 MHz to 800 MHz

 

 

800 MHz to 2.5 GHz

where P is the maximum output power  

rating of the transmitter in watts (W) 

according to the transmitter 

manufacturer and 

d

 is the recommend-

ed separation distance in meters (m).

Field strengths from fixed RF 

transmitters, as determined by an 

electromagnetic site survey,*2) should 

be less than the compliance level in 

each frequency range.*3) 

Interference may occur in the vicinity 

of equipment marked with the 

following symbol:

Summary of Contents for NEB402

Page 1: ...Instruction Manual NEB402 Handheld Mesh Nebulizer IFU 00059 REV 1 01 2022 10 12 Manufactured for Sunset Healthcare Solutions 180 N Michigan Ave Ste 2000 Chicago IL 60601...

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Page 3: ...very much for choosing our Handheld Mesh Nebulizer Please read this user manual carefully before using so that you can use it safely and correctly Please keep this user manual properly in place for fu...

Page 4: ...5 5 Product Technical Parameters 6 6 User Instructions 7 7 Cleaning Disinfection 10 8 Storage Conditions 12 9 Trouble Shooting 12 10 Note Warning 13 11 EMC Declarations 14 12 Signs Symbols 21 13 After...

Page 5: ...device if it is damaged or becomes wet The device is a Vibrating Mesh Nebulizer System designed to aerosolize liquid medication for inhalation therapy by the patient The device may be used with pedia...

Page 6: ...ion Rate 0 25ml min 0 9ml min Particle Size MMAD 5 m Medication Cup Capacity 10ml Max Vibration Frequency 110kHz 10kHz Weight 100g with batteries Size Length 38 5mm Width 53 4mm High 97 7mm Working En...

Page 7: ...rable period may vary depending on usage environment Main Unit 2 years Top Cover 2 years Medication Cup 2 years Medication Cover 2 years Mask PVC 1 year The nebulizer has a USB cable for charging it d...

Page 8: ...the device every 2 days to ensure normal use Continue charging the device at least once per month when not in use for more than one month The rechargeable battery should not be replaced by the user o...

Page 9: ...elow and click ON OFF switch to power on Please hold the nebulizer to keep liquid medication in contact with the vibrating mesh and the stream of inhalation Please see Figure 6 below Figure 5 Connect...

Page 10: ...medication cup and mask or mouthpiece We recommend one device be used and reused for a single person The device is not provided sterile 10 Step Four Figure 7 Pouring out the Residual Liquid Medicatio...

Page 11: ...owing the cleaning instructions after each use will prevent any remaining medication in the bottle from drying adhering to the mesh cap and resulting in the device not nebulizing effectively Please do...

Page 12: ...ditions 9 Trouble Shooting Item Trouble Possible cause solution 1 Does not work when turned on Check if there is enough power Check if there is enough medication Check if the medication cup has been f...

Page 13: ...non conforming adapter may cause equipment damage Please refer to the user manual when problems appear and contact the service center for maintenance Please clean and disinfect the medication cup when...

Page 14: ...may cause Bronchospasm The device can t be used on an aircraft One device is solely for single patient use and can be reused by a single patient One device is used for single medication Do not use mob...

Page 15: ...ce of this equipment could result 5 WARNING Do not use mobile cellular telephones and other devices such as MRI diathermy electrocautery RFID and electromagnetic security systems which generate strong...

Page 16: ...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 This device is suitable for use in all estab...

Page 17: ...lity should be that of a typical commercial and or hospital environment If the user of this device requires continued operation during power mains interruptions it is recommended that the device be po...

Page 18: ...3V rms 3V m Portable and mobile RF communica tions equipment should be used no closer to any part of this device including cables than the recommend ed separation distance calculated from the equation...

Page 19: ...should be less than 3 V m 19 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorpt...

Page 20: ...bove the recommended separation distance d in meters 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...

Page 21: ...mful substances and element Protected against solid foreign objects of 12 5 mm and greater Protection against vertically falling water drops when ENCLOSURE tilted up to 15 Date of manufacture Keep awa...

Page 22: ...push Operation indicator Storage and delivery temperature limits Storage and delivery humidity limitations Storage and delivery atmospheric pressure limitations Micro USB plug interface Press inside t...

Page 23: ...ed accordingly 2 Please contact us to obtain warranty service Warranty conditions To obtain the warranty service please present this warranty card and fill out the related content The company provides...

Page 24: ...riginal parts or accessories The manufacturer does not take responsibility for the buyer or third parties for any damage or loss intentionally or unintentionally caused by improper use On the request...

Page 25: ...if returning machine to maintenance The warranty period for the unit is 1 year The warranty for the medication cup is 6 months During the warranty period Sunset will decide to repair or replace damage...

Page 26: ...mful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful...

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