Boryan C5 Ultrasonic Nebulizer Machine Instruction Manual

Boryan C5 Ultrasonic Nebulizer Machine

Thank you very much for purchasing Boryan Nebulizer. Be sure to read this Instruction Manual before using the unit for you to use it safely and correctly. This unit is a medical instrument. Be sure to follow the instructions of a doctor and use the unit correctly.For the type, dose and regimen of medication, be sure to follow the instructions of a doctor. The nebulization characteristics of this unit differ by the properties of medication. Especially with the use of a medication having high surface activity or viscosity such as medication solubilizing agent or expectorant, the nebulization rate may be reduced. The nebulization rate may also be reduced when the temperature of medication is low.

Getting to Know Your Nebulizer

The Bryan Compressor Nebulizer Bryan C5 is intended to aerosolize physician- prescribed solutions for inhalation that are approved for nebulization. The device may be used for child and adult patients in the home, hospital and sub- acute care settings, tney are. not intended Tor lite Support nor do they prOvide any patient monitoring capabilities.

Specification

Contraindications and Adverse Reaction
Patients allergic to aerosolized drug The device should be used with caution or be used under the guidance of doctors by. patients, those who may shoW difficulty in breathing, apnea or continuous asthma during the process of atomization.

Patient Populations
This device is intended for use by children or adults.

Warnings and Cautions

Warning

Service or maintenance of the equipment is not permitted while used in patient. The patient should be an intended operator who can understand the instruction brochure and the operation of the device. When you use the unit for the first time after purchasing it or after not using it for a long period of time, be sure to clean and disinfect Medicine Cup, Inhalation Mask, Mouthpiece and Nosepiece (optional). If the device is stored in low temperature area for long time, please operate the device after leaving the device in normal temperature for at least 2 hours. Clean and disinfect Medicine Cup, Inhalation Mask and Mouthpiece after each use. Be sure to dry the cleaned and disinfected parts promptly, and store them in a clean place. Do not place or attempt to dry the device, components or any of the nebulizer parts in a microwave oven. Keep the device out of the reach of unsupervised infants and children. The device may contain small parts that can be swallowed. Do not wash the Main Unit and Power Plug with water or hot water. Do not immerse the Main Unit in water or other liquid. Do not cover the compressor with a blanket, towel or any other type of cover during use. This could result in the compressor overheating or malfunctioning. Do not touch the device for long time during the operation of the device considering the potential overheating hurt. Do not use the device where the device may be exposed to flammable gas or vapors. Pentamidine is not an approved medication for use with this device. Always dispose of any remaining medication in the medication cup in the sewer after each use. Do not leave the device or its parts where it will be exposed to extreme temperatures or changes in humidity, such as leaving the device in a vehicle during warm or hot months, or where it will be exposed to direct sunlight.
Do not use or store the device where it may be exposed to noxious fumes or volatile substances. Make sure that the Medicine Cup is clean before use. Do not use in anaesthetic or ventilator breathing circuits.
Risk of Electrical Shock:
Do not use the compressor (main unit) or Power Plug while they are wet. Do not plug or unplug the Power Plug into the electrical outlet with wet hands. Do not use or store the device in humid locations, such as a bathroom. Use the device within the operating temperature and humidity. Do not operate the device with a damaged power cord or plug. The device has to be repaired by trained professionals if the power cord is damaged.
Maintenance and Storage
Do not leave the cleaning solution in the nebulizer parts. Rinse the nebulizer parts with clean hot tap water after disinfecting. Store the device and the components in a clean, safe location.

Caution

Do not inhale by using water in the Medicine Cup. Do not spill water or other liquids on the compressor and Power Plug. These parts are not waterproof. If liquid spills on these parts, immediately unplug the Power Plug and wipe off the liquid with gauze or other soft absorbent material. Do not drop or apply strong shock to the Main Unit or Medicine Cup. Provide close supervision when this device is used by, on or near infants, children or compromised individuals. If the device is used continuously, the service life of the device may be shortened. Limit use to 20 minutes at a time, and allow a 40 minutes interval before using the device again. Do not insert any object into the compressor. Make sure the Air Filter is clean. If the Air Filter has changed color or has been used for more than 60 days, replace it with a new one. Make sure the Medicine Cup is correctly assembled, the Air Filter is properly installed, and the Air Tube is correctly connected to the compressor and the Medicine Cup. Air may leak from the Air Tube during use if not securely connected. Do not use the device if the Air Tube is bent. Do not add more than 8ml of medication to the Medicine Cup. Do not operate the device at temperatures greater than +40″C (+104″F). Do not tilt the Medicine Cup so the angle of the kit is greater than 45′. Medication may flow into the mouth. Use only Boryan authorized parts and accessories. Parts and accessories not approved for use with the device do not perform the expected specification or it may damage the unit. Changes or modification not approved by Boryan Healthcare will void the user warranty. To avoid injury to the nose mucosa, do not squeeze the optional Nosepiece into the back of the nose. When using this device, there will be some noise and vibration caused by the pump in the compressor. There will also be some noise caused by the emission of compressed air from the Medicine Cup. This is normal and does not indicate a malfunction.Do not use the device while sleeping or if drowsy. Remove the Power Plug from the device after use. Unplug the Power Plug from the electrical outlet before cleaning the device. Do not store the Air Tube with moisture or medication remaining in the Air Tube. This could result in infection as a result of bacteria. The handle of the device will be a little hot after continuous operation, please wait 5 minutes to touch it.

Maintenance

Precautions for Cleaning

• Clean the casing of the main unit by using a soft cloth moistened with water or mild detergent. Do not use abrasive cleaners.

Maintenance

• This product is generally recommended that it be inspected every two years to ensure proper function and performance.

Protect the Nature Environment

• Please help to protect natural environment by respecting national and/or local recycling regulations at the end of their useful life.

Components I Accessories

Name of each component

1. Compressor(Main Unit)
2. Air outlet
3. Air Tube
4. Power Switch
5. Power Line
6. Medicine Cup
7. Medicine Cup Holder
8. Air Filter Cover
9. Handle
10. Footpad
11. Medicine Cup Cover
12. Medicine Cup Upper Shell
13. Nebulizer Slice
14. Medicine Cup Bottom Shell

Name of Accessories:

• Medicine Cup
• Inhalation Mask (Adult & Child)
• Air Tube
• Air Filter

Operation Procedure

Prepare the Power Source

Fill in the Medication

• Step1: Lift up the Mouthpiece or Nosepiece Mask from the Medicine Cup.
• Step2: Unscrew the Medicine Cup Upper Shell as shown in picture A.
• Step3: Fill in the correct amount of prescribed medication in the Medicine Cup Bottom Shell as shown in picture B.
• Step 4: Screw the Medicine Cup Upper Shell to the Medicine Cup Bottom Shell clockwise until securely closed as the shown in the picture C.

Assemble the inhalation accessories

Assemble the Air Tube

• Step 1: Twist the Air Tube plug and push it firmly into the Air Tube Connector on the upper side of the compressor.
• Step 2: Twist the Air Tube plug slightly and push it firmly into the Air Tube connector on the bottom of the Medicine Cup.
• Step3: Use the Medicine Cup Holder as a temporary holder for the Medicine Cup.

How to Use the Unit

• Step1: Hold the Medicine Cup as shown in the Figure above.
• Step2: Turn on the Unit: Turn the Power Switch to the ON ( I ) position. As the compressor starts, nebulization begins. (To stop nebulization, turn the power switch to the OFF ( 0) position.)
• Step3: Inhale medication as instructed by physician shown as above.
• Step 4: Tum off the Unit: Turn the Power Switch to the OFF ( 0 ) position. As the compressor stops, nebulization stops.
• Step 5: Disconnect the Air Tube from the Medicine Cup. Hold the Air Tube Plug and gently pull it down.Check the Air tube. No condensation or moisture should remain in the Air Tube.
• Step 6: Disconnect the air tube from the compressor
• Step 7: Unplug the Power Plug

Note:
If any condensation or moisture remains in the Air tube, remove the moisture from the air tube. Follow the directions below:

1. Make sure the Air Tube is still connected to the air tube connector on the upper side of the compressor.
2. Turn on the Unit, and the compressor will start and pump air through the air tube to expel the moisture.
3. Tum off the Unit.

Cleaning and Disinfection

Clean the Unit after Inhalation

• Step 1 : Remove the inhalation accessory from the Medicine Cup.
• Step 2: Disconnect the Air Tube from the Medicine Cup.
• Step 3: Gently screw off the Medicine Cup Upper Shell.
• Step 4: Discard the remaining medication.
• Step 5: Wash the parts sufficiently in water.
• Step 6: Hand dry or air dry in a clean environment using a soft, clean, lint-free cloth.
• Step 7: Assemble the Medicine Cup and store it in a dry bag.

Disinfection

Disinfect the Medicine Cup and Mouthpiece, Masks or nosepiece after the last treatment of the day as following:
Use a commercially available medical alcohol disinfectant with the instructions provided by the disinfectant manufacturer(Recommended contact lime less than 10 seconds):

• Step 1: Submerge the parts in the disinfectant solution for the specified period.
• Step 2: Remove the parts and discard the solution.
• Step 3: Rinse the parts with clean Drinking Water, shake off excess water and allow to air dry in a clean environment.

Clear the Air Filter

• Step 1: Pull the Air Filter cover to remove from the back side of the compressor.
• Step 2: Remove the dirty Air Filter.
• Step 3: Insert a new Air Filter.
• Step 4: Put the Air Filter cover back to the compressor.

Note:

• If the Air Filter has changed color or has been used for more than 60 days, replace ii with a new one.

Troubleshooting Problems

the AC ada/hter into an electrica outlet. Tum e device on.
| No medication in the Medicine Cup.**

Too much or too little medication in the Medicine Cup.

| ****

Add the correct amount of prescribed medication to the Medicine Cup.

No nebulization or low nebulization rate when the power is on.| ****

The Baffler is not attached to the Medicine Cup Upper Shell or incorrectly positioned.

| ****

Make sure the Baffler is correctly attached to the Medicine Cup Upper Shell.

| ****

The Medicine Cup is not correctly assembled.

| Make sure the Medicine Cup is correctly assembled and the inhalation accessory is correctly attached.
Trouble| Possible Cause| How to Correct
---|---|---

No nebulization or low nebulization rate when the power is on.

| ****

The nozzle is blocked.

| Clean and disinfect the Nebulizer Kit to remove the blockage

The Medicine Cup is tilted at an incorrect angle.

The Air Tube is incorrectly attached.

| Hold the Medicine Cup correctly. Do not tilt the Medicine Cup so the angle of the kit is greater than 45 degrees.

Make sure the Air Tube is correctly attached to the compressor and the Medicine Cup.

The Air Tube is folded or damaged.

The Air Tube is blocked.

| Make sure the Air Tube is not folded, kinked or bent. Inspect the Air Tube for any damage. Replace the Air Tube if damaged.
The Air Filter is dirty| Replace the Air Filter with a new clean Air Filter.

The device is very hot.

| The compressor is covered.| Do not cover the compressor with any type of cover during use.

Operating continuously over 20 minutes.

| Limit use to 20 minutes at a time and allow a 40 minutes interval before using the devise again.
The device is abnormally loud.| ****

The Air Filter cover is incorrectly attached.

| Attach the Air Filter cover correctly. Make sure the Air Filter cover is not blocked.

Note:
If any operator requests more information such as circuit diagrams, parts list and product descriptions, for repairs carried out by qualified technical personnel, please contact us. If the unit does not nebulize normally after taking the above-mentioned procedure, contact the store where you purchased the unit or the nearest VAPO dealer.

Symbol Form

Guidance and Manufacturer’s Declaration

1. This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS;
2. IMMUNITY TEST LEVELS for basic safety and essential performance of ME equipment and ME systems should be chosen based on a high probability of maintaining basic safety and essential performance, and shall be according to the professional healthcare facility environment, home healthcare environment, and special environment, based on the locations of intended use.
3. HOME HEALTHCARE ENVIRONMENT is dwelling place in which a patient lives or other places where patients are present, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present. Such as schools, outdoors, domiciles, vehicles hotels and pensions.

EXAMPLE: As indicated in Table of IEC 60601-1-2:2014 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d = 3.3 m at an IMMUNITY LEVEL of 3 Vim.

A1 Electromagnetic Emissions-For all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration-electromagnetic emission

The “Boryan Compressor Nebulizer Boryan C5” is intended for use in the electromagnetic environment specified below; The customer or the user of the “Boryan Compressor Nebulizer Boryan C5” should assure that it is used in such and environment.
Emission test| Compliance| Electromagnetic environment-guidance

RF emissions CISPR 11

|

Group 1

| The “Boryan Compressor Nebulizer Boryan C5” uses RF energy only for its internal 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|

The “Boryan Compressor Nebulizer Boryan C5” is suitable for use in all establishments,

other than domestic and those directly connected to the public low-voltage power supply network that supplies building used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

|

Class A

Voltage fluctuations/flick-

er emissions

IEC61000-3-3

|

Complies

Guidance and manufacturer’s declaration-electromagnetic emission  The “Bryan Compressor Nebulizer Boryan C5” is intended for use in the electromagnetic environment specified below; The customer or the user of the “Bryan Compressor Nebulizer Bryan C5” should assure that it is used in such and environment.

A2 Electromagnetic Immunity -For Home Healthcare Environment EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration – electromagnetic immunity

The “Boryan Compressor Nebulizer Boryan C5” is intended for use in the electromagnetic environment specified below; The customer or the user of the “Boryan Compressor

Nebulizer Boryan C5” should assure that it is used in such and environment.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic

environment -guidance

Electrostatic discharge (ESD) IEC 61000-4- 2

|

±8kV contact

± 2kV,±4kV,± 8

kV,± 15kV air

|

±8kV contact

± 2kV,±4kV,±

8kV,± 15kV air

| Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4|

±2KV for power supply lines

|

±2KV for power supply lines

| Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

|

±1 kV line to line

±2kV line to ground

|

±1 kV line to line

±2kV line to ground

| Mains power quality should be that of a typical commercial or hospital environment.
Power frequency (50/60Hz)

magnetic field IEC 61000-4- 8

|

30Nm

|

30Nm

| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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

|

0%UT;

0,5 cycle

At 0″, 45″, 90″,

135″, 180″, 225″,

270″ and 315″

|

0%UT;

0,5 cycle

At 0″, 45″, 90″,

135″, 180″, 225″,

270′ and 315′

| Mains power quality should be that of a typical commercial or hospital environment. If the user of the “Boryan Compressor

Nebulizer, Boryan C5” requires continued operation during power mains interruptions, it is recommended that the “Boryan Compressor

Nebulizer, Boryan C5” be powered from an uninterruptible power

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

| ****

3 Vrms

150 kHz to 80 MHz

10 Vim

80 MHz to 2.7 GHz

| ****

3Vrms

10Vim

| The MANUFACTURER

should consider reducing the minimum  separation d stance, based on

RISK MANAGEMENT, and

us ng higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance. Minimum separation distances for

h gher IMMUNITY TEST

LEVELS shall be calculated us ng the following equation:

---|---|---|---
| | |
| | | Where P is the maximum power in W, d is the minimum separation distance in m , and E is the IMMUNITY TEST LEVEL in

Vim.

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

Nebulizer Boryan C5″ should assure that it is used in such an environment.

Warranty Card

MODEL|
---|---
Warranty Period| One year from purchasing date
Customer Information| Order ID:| I| Name:
Address:| I| Phone Number:

Requiring Record

Guarantee Regulation

| The Guarantee is for the Main Unit, not applicable for the Medicine Cup as the service life of the medicine cup varies greatly according to usage.

·          The product must be accompanied by proof of purchase, either a bill of sale or other proof supporting that the device is within warranty period.

·          This warranty does not apply to a product which has been damaged as a result of improper maintenance, an accident, improper voltage supply or any other form of misuse. The warranty is also void if the owner repairs or modifies the product in any way. Boryan is not liable for any incidental or consequential damages with regard to this product. The warranty also excludes any liability other than what is stated above. No other warranty is given.

·      LEGAL RIGHTS VARY FROM COUNTRY TO COUNTRY. SOME COUNTRIES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION MAY NOT APPLY

TO YOU.

Support@boryan.store I www.boryan.store

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