Sunset Healthcare NEB400 Instruction Manual

Instruction Manual
Mini Mesh Nebulizer
NEB400
Rx only
Table of Contents
1. Before Using the Device
2. Correct Use of the Unit
3. Correct Cleaning and Disinfection Procedure
4. Troubleshooting and Specifications
2.2 How to Insert or Replace the Batteries ...............................................................11
2.3 How to Connect the Power Adapter to Nebulizer ..............................................13
2.4 How to Assemble the Unit and Fill the Medication Cup ....................................15
2.5 How to Select the Nebulization Mode .................................................................17
2.6 How to Inhale with the Mini Mesh Nebulizer .....................................................17
3.1 How to Clean the Unit after Each Use ..................................................................19
3.2 How to Disinfect the Unit ......................................................................................21
4.1 Troubleshooting ......................................................................................................22
4.2 Technical Data .........................................................................................................24
4.3 Electromagnetic Compatibility Data .....................................................................28
1
1. Before Using the Device
Thank you for purchasing the Sunset NEB400 Mini Mesh Nebulizer. Before using the nebulizer for the rst time, please read the instructions thoroughly and use it correctly. To further understand the device and suitable medications, please be sure to follow a doctor’s instruction. Additional questions can be directly addressed to your place of purchase/local supplier.
The Mini Mesh Nebulizer can be powered by two AA alkaline batteries or USB cord.
Caution: Federal law restricts this device to sale by or on the order of a physician
ONE YEAR LIMITED WARRANTY
Sunset Healthcare Solutions offers a limited 1-year warranty on the Mini Mesh Nebulizer unit to be free from defects in material and workmanship under normal use and operation for a period of 1 year from date of original retail purchase. This warranty does not extend to failures resulting from accidental damage, misuse, negligence, abuse, alteration, or improper operation. This warranty does not extend to non-durable components which are subject to normal wear and need periodic replacement nor does this warranty extend to hospital or clinic use. All items returned must be properly packaged and shipped in a manner to avoid shipping damage at the purchaser’s expense.
DO NOT return any product(s) or part(s) to Sunset Healthcare Solutions without prior consent. For replacement under warranty, please call: 1-877-578-6738 (Monday to Friday, 9 am to 5 pm CST).
1.1 Introduction
2
The following items are contained in the package. Please check all parts for visible damage. Replace any damaged parts before use. In the case of missing parts, malfunction, or damage, please contact your local dealer/place of purchase.
Check before use
1. Main unit
4. Instruction manual
7. Adult mask NEB400-MASKA
5. Bag
8. Pediatric mask NEB400-MASKP
NEB400-CUP
2. Medication cup 3. USB cord
6. Mouthpiece NEB400-MP
1.2 Contents of the Mini Mesh Nebulizer Package
Instruction Manual
Mini Mesh Nebulizer
NEB400
3
Note
To order replacement part (medication cup) or accessories, please contact your local supplier. Information regarding serial number can be obtained by reading or scanning QR code on the main unit.
The Mini Mesh Nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation to a patient except for Pentamidine. The device may be used with patients 5 years and older in the home, hospital, and sub-acute care settings.
1.3 Intended Use
**Please replace parts in the following situations:
• After using the main unit for 2 years.
• After using the medication cup for 1 year. Medication cup should be inspected after each cleaning for physical damage, cracks or leaks.
If medicine cup is not in good condition after inspection or takes longer
than 10 minutes to deliver 2mL of mediction, it should be replaced.
Warning
Do not use the device where it may be exposed to ammable gas.
4
WARNINGS
• The nebulizer is intended for aerosolizing respiratory medication and only doctor’s prescribed
medication can be used. The manufacturer cannot be held liable for any damage caused by improper or incorrect use.
• To reduce the spread of infectious diseases, do not share the nebulizer, it is intended to be
used by a single user.
• Device needs to be cleaned and disinfected in accordance with the user manual to avoid
possible contamination.
Do not operate the device if any of the parts are damaged or a fault is suspected.
Do not connect nebulizer with other medical ventilation systems to avoid possible damage.
• Adult supervision is required when device is used by children and individuals who require
special assistance.
Do not remove medication cup during nebulization to avoid possible electrical shock by
accidentally contacting the electrodes.
Do not connect the adapter to the AC outlet under the following circumstances to avoid
possible electrical shock:
- when malfunction occurs during operation
- when cleaning and disinfecting the device
- when nebulizer is not used
Do not expose the main unit or adapter to water in order to avoid malfunction or electrical
shock.
Do not pull the cable of power adapter for disconnecting from the AC outlet.
To ensure safe and effective use of the nebulizer, please read the instruction manual carefully before using.
1.4 Safety Precautions
5
CAUTIONS
• Clean the nebulizer before rst use, after each use and after extended storage to avoid unwanted contamination.
• Clean and disinfect the mesh in accordance with the user manual to avoid possible damage.
• Operational temperature should be kept within 10 ~ 40°C / 50 ~ 104°F to avoid damaging the device.
• Storage temperature should be kept within -20 ~ 70°C / -68 ~ 158°F to avoid damaging the device.
Do not drop the device to avoid potential malfunction.
Do not poke mesh module. The device may be broken.
Do not modify the device in any way to avoid potential damage.
• The device is MRI unsafe, do not use in an MRI environment.
• Interference may occur in the vicinity of equipment with this mark:
Do not use close to strong electrical or electromagnetic elds. This may result in incorrect operation and create a potentially unsafe condition.
Do not turn on the nebulizer when medication cup is empty.
Anti-theft systems and Radio Frequency Identication (RFID) readers are used in a wide variety of settings, including supermarkets, shopping malls, libraries and hospitals. Metal detectors for airport and facility security applications can either be portals that a person walks through, or can be hand-held “wands” that are passed over a person’s body.
Exposure to these systems can result in thedevice turning off automatically. If this occurs, move away from the system, turn the device off,remove batteries, insert again andthen turnon. Normal operation should resume.
Patients should take the following precautions:
• Be aware that anti-theft systems and RFID readers in many commercial establishments can be hidden or camouaged in entrances and exits where they are not readily visible.
• Do not stay near the anti-theft system, RFID reader or metal detector longer than is necessary and do not lean against them.
• If you are scanned with a hand-held metal detector, advise the security personnel that you have an electronic medical device and ask them not to hold the metal detector near the device any longer than is absolutely necessary; or, request an alternate form of personal search.
6
Symbols Meaning
Caution or Warning, consult accompanying documents
BF type is a degree of protection against electrical shock (applied part).
Protects against solid foreign objects that are >12.5 mm in diameter and drops of water falling at up to 15° from the vertical.
Read the instruction manual carefully.
Serial number
Catalog number
Disposal of Electrical & Electronic Equipment (WEEE): Do not treat this product as household waste.
Date of manufacture
Name and address of manufacturer
Unsafe for use with magnetic resonance imaging
SN
REF
MR
1.5 Classification and Explanation of Symbols
7
1. Medication cup cap
To be opened when lling the medication or cleaning the cup.
2. Cup
Prescribed nebulizer medication can be lled here by opening the cap (8 ml/cc).
3. Mouthpiece
To be placed between teeth with lips rmly sealed around it, and to facilitate inhalation of aerosolized medication.
4. Nebulizing mesh
The module oscillates at high frequency and pushes the medication through the apertures on mesh.
Do not touch this portion with your ngers or other foreign objects. Do not attempt to clean with a cotton swab or a pin.
5. Nebulization port
Nebulized medication exits here.
6. Medication cup lock
Medication cup is securely locked into the main unit before nebulization.
1.6 Components
Medication Cup
1
2
3
4
6
6
5
6
8
Main Unit
7. ON/OFF button
8. Electrodes
Connects the main unit with the nebulizing mesh on medication cup.
9. Inner latch
Medication cup is securely installed onto the main unit before nebulization.
10. Power indicator
A green light turns on when the power is on.
11. Low power/malfunction indicator
An orange light blinks when the batteries are low. No light indicates malfunction.
12. Medication cup release button
Medication cup can be removed when the button is pushed.
13. Battery cover
14. USB power socket
15. USB power socket cover
Bottom side
Press Release Button to remove the medication cup.
7
9
9
10-12
8
13
14
15
9
2. Correct Use of the Unit
2.1 Using the Nebulizer with Batteries or USB Cord
Battery Power
Step 1. Check the parts
(Refer to Chapter 1.2)
Step 2. Clean and disinfect
the medication cup when using the
nebulizer for the rst time (Refer to Chapter 3)
Step 3. Insert batteries
(Refer to Chapter 2.2)
Step 4. Assemble the main unit and medication cup
(Refer to Chapter 2.4)
Step 5. Fill the cup with medication
(Refer to Chapter 2.4
)
Step 6. Press power button to turn on
Step 7. Inhale the aerosolized medication
(Refer to Chapter 2.6)
Step 8. Press power button to turn off
(Refer to Chapter 2.6)
Step 9. Clean the unit and disinfect the medication cup
(Refer to Chapter 3)
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