background image

Floors should be wood, 

concrete or ceramic tile. If 

floors are covered with

synthetic material, the 

relative humidity

should be at least 30 %.

Mains power quality should 

be that of a typical 

commercial or hospital 

environment.

Mains power quality should 

be that of a typical 

commercial or hospital 

environment.

Mains power quality should be 

that of a typical commercial or 

hospital environment. If the user 

of the Mesh Nebulizer with 

Rechargeable Battery requires 

continued operation during 

power mains interruptions, it is 

recommended that the Mesh 

Nebulizer with Rechargeable 

Battery be powered from an 

uninterruptible power supply or 

a battery.

Guidance and manufacturer's declaration – electromagnetic immunity – for all 

EQUIPMENT and SYSTEMS

Guidance and manufacturer´s declaration – 

electromagnetic immunity

The Mesh Nebulizer with Rechargeable Battery is intended for use in the 
electromagnetic environment specified below.
The customer or the user of the Mesh Nebulizer with Rechargeable Battery 
should assure that it is used in such an environment.

Electrostatic 

discharge (ESD) 

IEC 61000-4-2

Electrostatic 

transient / burst 

IEC 61000-4-4

Voltage dips,short 
interruptions and 
voltage variations 
on power supply 
input lines EN 
61000-4-11

Surge

IEC 61000-4-5

IEC 60601 

test level

Compliance 

level

Electromagnetic 

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 

70 % UT;25/30 

cycles
Single phase: at 0° 

0 % UT; 250/300 

cycle  

N/A

N/A

Recommended separation 
distance

Power frequency magnetic 

fields should be at levels 

characteristic of a typical 

location in a typical 

commercial or hospital 

environment.

Power frequency 

(50/60 Hz) 

magnetic field IEC 

61000-4-8

NOTE

UT is the a. c. mains voltage prior to application of the test level.

30 A/m

30 A/m

N/A

N/A

Immunity test

Portable and mobile RF 

communications equipment 

should be used no closer to 

any part of the Mesh 

Nebulizer with Rechargeable 

Battery ,including cables, 

than the recommended 

separation distance 

calculated from the equation 

applicable to the frequency 

of the transmitter

Guidance and manufacturer´s declaration – electromagnetic immunity –for 

EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING

Guidance and manufacturer´s declaration – 

electromagnetic immunity

The Mesh Nebulizer with Rechargeable Battery is intended for use in the electromag-
netic environment specified below. The customer or the user of the Mesh Nebulizer 
with Rechargeable Battery should assure that it is used in such an environment.

Conducted RF 

IEC 61000-4-6

EN 60601 

test level

Compliance 

level

Electromagnetic 

environment - guidance

3V rms

150kHz to 80MHz 

6V in ISM bands 

between 0

.

15MHz 

and 80 MHz

Immunity test

28

29

d=[3.5/V1]

Содержание NEB401

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 22: ......

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