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Summary of Contents for Sunset Healthcare NEB401
- Page 1 Instruction Manual Mesh Nebulizer with Rechargeable Battery NEB401 Manufactured for Sunset Healthcare Solutions 180 N Michigan Ave Ste 2000 Chicago, IL 60601 NEB401-IFU V1.01 Rx Only www.sunsethcs.com 2020-06-29...
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Page 2: Table Of Contents
Table of Contents Indications for Use The Mesh Nebulizer with Rechargeable Battery is designed to aerosolize liquid medications for inhalation by patient, the device may be used with pediatric (>4 Chapter 1 Before you start years of age) and adult patients in the home, hospital and sub-acute care settings. It is not intended for use with Pentamidine. - Page 3 Maintenance To protect the environment READ ALL CONTRAINDICATIONS, WARNINGS AND SAFETY Chapter 6 Troubleshooting PRECAUTIONS BEFORE USE, AND STRICTLY FOLLOW THEM WHEN USING THE NEB401 MESH NEBULIZER! Troubleshooting Chapter 7 Customer Service NOTE ! Warranty Information Before initial use please charge the nebulizer for minimum ONE hour so that the device can be activated.
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Page 4: Medications For Inhalation By Patient, The Device May Be Used With Pediatric
1. What is the Mesh Nebulizer with Rechargeable Battery? 3. Getting to Know your Device The Mesh Nebulizer with Rechargeable Battery is designed to aerosolize liquid medications for inhalation by patient. The device may be used with pediatric (>4 years Main Unit Provides power of age) and adult patients in the home, hospital and sub-acute care settings. -
Page 5: Indications For Use
4. Indications for Use Chapter 2 Important Safety Information The Mesh Nebulizer with Rechargeable Battery is designed to aerosolize liquid medications for inhalation by patient, the device may be used with pediatric (>4 years of age) and adult patients in the home, hospital and sub-acute care settings. Important Safety Information - Read Before Use! It is not intended for use with Pentamidine. - Page 6 Warning: To prevent cross infection, the device is used only by single patient. Do NOT use mouthpiece and masks if its package is broken. Warning: Do not dry the device or its accessories with an oven, microwave, Do NOT use the device if your hands are wet. hair dryer, etc.
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Page 7: Chapter 3 Safety Features Of The Nebulizer
1. Power Supply Chapter 3 Safety Features of the Nebulizer This nebulizer is powered with a built-in lithium battery. The battery can be charged with the USB cord. 1. Additional considerations To connect This device is approved for human use only. (1) Connect small end of USB cord to the USB port on the bottom of the nebulizer. -
Page 8: Nebulizer Assembly
2. Nebulizer Assembly NOTE ! (1) Please clean and disinfect nebulizer before first using and after each using, then (1) After putting medication in, avoid shaking your device, which may cause dry it. See Chapter 5 for details. leakage of medication. (2) Use one hand to hold the Main Unit, the other hand to hold the Medicine Cup. - Page 9 NOTE ! (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 Press malfunction. In order to avoid emergencies such as accidents or acute asthma attacks, it is recommended to have a backup device.
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Page 10: Turn Off Power
5. Turn Off Power (3) Open the lid, pour out all the residual liquid, and promptly clean and disinfect the device, allow all the parts to air dry and store the device in a clean environment. Press the Power button to turn off the power. The Power Indicator (Green Light) will See Chapter 5 for more information. -
Page 11: Disinfecting
2. Main Unit 1.4 Wipe the chambers of the Medicine Cup with a lint-free towel moistened with 70% ethyl alcohol at least 3 times and air dry; Then re-add purified water (3-6 ml). 2.1 After use, gently wipe the Main Unit and Electrodes (connecting the Main Unit and 1.5 Press and hold the Power button for 3 seconds WHILE THE DEVICE IS OFF, this will turn Medicine Cup) with a dry clean medical gauze to ensure an effective connectivity on the light and alternate between green and blue colors. -
Page 12: Cleaning And Disinfecting Of Mouthpiece And Masks
(3) If the device has been stored at low or high temperature, the device needs more NOTE ! than half an hour to adjust, until it is ready for intended use. Validity: When nebulizing 0.9% sodium chloride solution for 2 times a day, and 15 (1) To prevent disinfecting agent from touching skin, please wear rubber gloves. -
Page 13: Troubleshooting
Chapter 6 Troubleshooting PROBLEM CAUSE SOLUTION Indicator light The battery is low. Recharge battery before using. is blue PROBLEM CAUSE SOLUTION Unsure which Only use under guidance of 1. The battery is very low 1. Recharge the battery before use medicine is suitable Consult your doctor. -
Page 14: Chapter 7 Customer Service
Chapter 8 Product Specifications If mesh nebulizer is broken/damaged and needs repair or any other user assistance, Name Mesh Nebulizer with Rechargeable Battery please contact your place of purchase. Model NEB401 Dimensions Approx. 50mm(L)×79mm(W)×111mm(H) Weight Approx. 106g Input: 100-240V AC 47-63Hz 0.4-0.2A AC power supply Output: 5V DC 2.4A Max. -
Page 15: Chapter 9 Electromagnetic Compatibility
Chapter 9 Electromagnetic Compatibility Guarantee Time Main Unit 1 Year (Medicine Cup is not included) Environmental temp:5 ℃~40℃, Do not use the device in the direct vicinity of short-wave or microwave equipment. Operating Temperature Relative humidity : 15~90% RH, not in Coagulation situation Air Pressure: (70.0~106.0)kPa Do not connect this equipment to other equipment. - Page 16 Guidance and manufacturer´s declaration – electromagnetic emission – for all Table 4 Guidance and manufacturer’s declaration-electromagnetic emissions EQUIPMENT AND SYSTEMS Item Applied standard Result Guidance and manufacturer´s declaration – electromagnetic emission Emission Measurement The Mesh Nebulizer with Rechargeable Battery is intended for use in the IEC 60601-1-2:2007 PASS Radiated emission...
- Page 17 Guidance and manufacturer's declaration – electromagnetic immunity – for all Power frequency magnetic EQUIPMENT and SYSTEMS fields should be at levels Power frequency (50/60 Hz) characteristic of a typical 30 A/m 30 A/m Guidance and manufacturer´s declaration – magnetic field IEC location in a typical electromagnetic immunity 61000-4-8...
- Page 18 Recommended separation distances between portable and mobile RF EN 60601 Compliance Electromagnetic Immunity test communications equipment and the EQUIPMENT or SYSTEM -for EQUIPMENT test level environment - guidance level and SYSTEMS that are not LIFE-SUPPORTING d=[3.5/E1] Recommended separation distances between portable and mobile RF communications equipment and d=[7/V1] the Mesh Nebulizer with Rechargeable Battery...
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Page 19: Notes On Fcc Certification
Chapter 10 Symbol Glossary NOTE1. At 80 MHz and 800 MHz, the separation distance for the higher requency range applies. NOTE2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. - Page 20 Mesh Nebulizer with Rechargeable Battery Service Warranty Card Name Product model Date of purchase Address Sales shop name Zip code Sales shop address Dealer info...
- Page 21 WARNING – No modifications of this equipment are allowed...
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