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Picture 13 Aerosol Particle Equivalent Volume

(1) It was tested by Pulmicort under the condition of temperature 24±2

humidity 45-75%R.H, Pressure: from 86 kpa to 106 kpa.
(2) MMAD (µm): 2.2µm ±25%
Respirable fraction (%, 0.5-5 µm) : ≥ 80%
Aerosol output rate (ml/min) : 0.24 ± 0.02 ml/min

The Mesh Nebulizer with Rechargeable Battery has been tested and found to comply 
with the limits for medical devices in IEC 60601-1-2. These limits are designed to provide 
reasonable protection against harmful interference in a typical medical installation. 
If other devices cause harmful interference to this device, the user is encouraged to try 
to correct the interference by one or more of the following measures:
    Reorient or relocate this device.
    Increase the separation between the interference equipment.
    Connect the equipment into an outlet on a circuit different from that to which the    
     other device(s) are connected.
    Consult the manufacturer for help.

1. Electromagnetic Compatibility

Do not connect this equipment to other equipment. Consult your physician for users 

wearing a heart pacemaker.

Do not use the device in the direct vicinity of short-wave or microwave equipment.

             Warning:

 

Use of this equipment adjacent to 

or stacked with other equipment should be avoided 
because it could result in improper operation. If such 
use is necessary, this equipment and the other 
equipment should be observed to verify that they 
are operating normally

.

            

Warning:

 

Use of accessories, transducers 

and cables other than those specified or provided by 
the manufacturer of this equipment could result in 
increased electromagnetic emissions or decreased 
electromagnetic immunity of this equipment and 
result in improper operation.

           

Warning:

 

Portable RF 

communications equipment 
(including peripherals such as 
antenna cables and external 
antennas) should be used no 
closer than 30 cm (12 inches) 
to any part of the [ME 
EQUIPMENT or ME SYSTEM], 
including cables specified by 
the manufacturer. Otherwise, 
degradation of the 
performance of this 
equipment could result.

Guarantee Time

Main Unit 1 Year (Medicine Cup is not included)

Operating Temperature

Environmental temp:5 

~40

,

Relative humidity : 15~90% RH, not in Coagulation situation

Air Pressure: (70.0~106.0)kPa

Storage and transport 

Temperature

Accessory

Environmental temperature: -25

~70

Relative Humidity: ≤90%R.H.  

Air Pressure: (70.0~106.0)kPa
Mouthpiece, adult Mask, child Mask, Adapter, 

Instruction Manual

24

25

Chapter 9   Electromagnetic Compatibility

NOTE !

Aerosol particle equivalent volume (Picture 13)

Summary of Contents for NEB401

Page 1: ...uction Manual Mesh Nebulizer with Rechargeable Battery NEB401 Rx Only Manufactured for Sunset Healthcare Solutions 180 N Michigan Ave Ste 2000 Chicago IL 60601 www sunsethcs com NEB401 IFU V1 01 2020...

Page 2: ...nt the device may be used with pediatric 4 years of age and adult patients in the home hospital and sub acute care settings It is not intended for use with Pentamidine Table of Contents Chapter 1 Befo...

Page 3: ...ooting Chapter 7 Customer Service Electromagnetic Compatibility Notes on FCC certification Chapter 9 Electromagnetic Compatibility Symbol Glossary Chapter 10 Symbol Glossary Cleaning Disinfecting Clea...

Page 4: ...with pediatric 4 years of age and adult patients in the home hospital and sub acute care settings It is not intended for use with Pentamidine 1 What is the Mesh Nebulizer with Rechargeable Battery 2...

Page 5: ...nvironment Warning For type or dose of medicine please follow the instructions of your physician and or licensed healthcare practitioner Important Safety Information Read Before Use The Mesh Nebulizer...

Page 6: ...on in the treatment area such as sores herpes simplex or open wounds If you are not sure the device is safe for you or not please consult your doctor PRECAUTIONS Take the following precautions to avoi...

Page 7: ...e end of USB cord to an adapter or other USB port such as USB port on a computer This nebulizer is powered with a built in lithium battery The battery can be charged with the USB cord 1 Power Supply C...

Page 8: ...ed in the right place the device may not be able to operate normally NOTE Picture 5 Mask Assembly and Mouthpiece Assembly 4 Usage of Nebulizer Nebulizer Accessories are categorized as mouthpiece adult...

Page 9: ...hile nebulizing 1 If this nebulizer is being used to treat a life threatening condition a backup device is necessary 2 The nebulizer may be unable to be used due to power failure or mechanical malfunc...

Page 10: ...n off the power The Power Indicator Green Light will go out 1 Cleaning Chapter 5 Maintenance of the Nebulizer Be sure to turn off the device After each use first discard all residual medicine and remo...

Page 11: ...r 3 6 ml 1 5 Press and hold the Power button for 3 seconds WHILE THE DEVICE IS OFF this will turn on the light and alternate between green and blue colors Release the button allowing the device to ent...

Page 12: ...utes for each time 3 years for main unit 3 months for Medicine Cup For the battery the device can be used for approximately 8 days after charging if operating for 30 minutes a day Lithium battery has...

Page 13: ...se under guidance of doctor s prescription The device is on but weak 1 Recharge the battery before use 2 Clean the device by adding water to the Medicine Cup press the power button for 3 seconds then...

Page 14: ...red equipment Nebulization Rate 0 2ml min minimum Particle Size 2 2 m 25 Medicine Capacity 8ml maximum 0 5ml minimum Battery Life the battery can be used for approximately 8 days after charging if ope...

Page 15: ...Warning Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other equipme...

Page 16: ...issions are very low and are not likely to cause any interference in nearby electronic equipment The Mesh Nebulizer with Rechargeable Battery is suitable for use in all establishments including domest...

Page 17: ...ectromagnetic environment guidance 8 kV contact 15 kV air 8 kV contact 15 kV air 2 kV for power supply lines 1 kV differential mode 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 7...

Page 18: ...fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked wit...

Page 19: ...hat to which the receiver is connected Consult the dealer or an experienced for help This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This devi...

Page 20: ...Name Tel Sales shop name Sales shop address Address Zip code Product model Date of purchase Dealer info Mesh Nebulizer with Rechargeable Battery Service Warranty Card...

Page 21: ...WARNING No modifications of this equipment are allowed...

Page 22: ......

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