Zewa NEB-36555 Compact Compressor Nebulizer Instruction Manual

Zewa NEB-36555 Compact Compressor Nebulizer

INSTRUCTION

Thank you for purchasing the NEB-36555 compressor nebulizer. This product is developed for the successful treatment of asthma, allergies and other respiratory disorders. The compressor forces air to the nebulizer. When the air enters the nebulizer, it converts the prescribed medication into an aerosol of microscopic droplets that can easily inhaled. The patient is the intended operator. -The device is single-patient-reuse.- Contraindications: None.

SYMBOLS

SAFETY INFORMATION

To ensure the correct use of the product, basic safety measures should always be followed including the warnings and cautions listed in this instruction manual.
WARNING

•  This device is not suitable for use in an anaesthetic breathing system or a ventilator breathing system.
• For the regime of medication shall follow the instructions of your physician or licensed healthcare practitioner.
• Always dispose of any remaining medication in the nebulizer cup after each use. Use fresh medication each time you use the device.
• This device is not designed to be used by persons (including children) with limited physical, sensory or mental abilities, or by persons with insufficient experience and/or knowledge, unless under observation by a person responsible for their safety, or unless they have been instructed in the use of the device.
• Do not use the device where the device may be exposed to flammable gas or vapours.
• This device shall be disconnected from the power source after use.
• Do not use the device with other medical electrical equipment simultaneously.
• Do not use only water in the nebulizer for nebulizing purposes.
• Use the device only for its intended use as described in the instruction manual. Do not use attachments not recommended by the manufacturer.
• To avoid the risk of entanglement and strangulation, store cables and air tubes out of the reach of small children.

CAUTION

• Never cover the compressor while it is operating.
• Do not block the ventilation slots. Never place the device where the ventilation slots may be obstructed during operation.
• Limit the use of the device to 20 minutes at a time, and wait 40 minutes before using the device again.
• Do not use the device if the air tubing is obstructed, bent or kinked (air tubing should be straight and not obstructed).
• Do not block the air filter cover.
• Do not alter the baffle, the nozzle in the medication tank or any part of the nebulizer kit.
• Do not operate the device at temperatures higher than 40 C (104°F).
• Do not subject the compressor, or any of the components to strong shocks, such as dropping on the floor.
• The performance of the device may vary with drugs such as suspension or high viscosity.
• This device conforms to EMC standard IEC 60601-1-2. However, the functioning of this device can be affected by electromagnetic interference exceeding the levels specified in IEC 60601-1-2.
• Dispose of the device, components and optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution.

RISK OF ELECTRICAL SHOCK

• Do not use the compressor (main unit) and the power cord while they are wet.
• Do not plug or unplug the power cord into the electrical outlet with wet hands.
• Do not immerse the compressor (main unit) in water or other liquid.
• Do not spill water or other liquids on the compressor. These parts are not waterproof. If liquid spills on these parts, please unplug the power cord and wipe off the liquid with gauze or other soft absorbent material immediately.
• Do not use or store the device in humid locations or outdoors. Use the device within the operating temperature and humidity.
• Do not overload power outlets. Plug the device into the appropriate voltage outlet.
• Do not use extension cords. Plug the power cord directly into the electrical outlet.
• Unplug the power cord from the electrical outlet after using the device. Never leave this product unattended when plugged in.
• Unplug the power cord from the electrical outlet before cleaning the device.
• Completely read all of the instructions including the optional accessories before using them.
• Not to position the ME EQUIPMENT so that it is difficult to operate the disconnection device.
• The power switch is used to isolate the device from the supply mains.
• The direction of movement of the actuator of the supply mains switch complies with IEC 60447.

MAINTENANCE AND STORAGE

• Wash the nebulizer parts after each use. Dry the parts immediately after washing.
• Keep the device out of the reach of unsupervised infants and children. The device may contain small parts that can be swallowed.
• Do not store the air tube with moisture or medication remaining in the air tub. This could result in infection as a result of bacteria.
• Store the device and the components in a clean, safe location.
• 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.
• Make sure that the air filter is clean. Please check the air filter at regular intervals (after every 10 applications). If it is soiled (grey or brown colour) or blocked, replace it. If the air filter has been used for 60 days, replace it.
• Do not wrap the power cord around the compressor (main unit).

The following are maintenance and repairs that can be taken by the operator, or which must be operated by the manufacturer or distributor

All components (including fuse, power cord) that need to be repaired or changed by disassembling the device| Distributor or manufacturer

MAIN UNIT

1. Power switch
2. Holder for Nebulizer
3. Air Connector
4. Dust Screen Cover
5. 5. Nebulizer Kit
6. Handle
7. Main Unit
8. thermal Via
9. Rubber Foot
10. Inhalation Tube
11. Corrugated Pipe
12. T-Type Connector
13. Inhalation Mouthpiece
14. Air Filter

The nebulizer kit and mask, nasal piece, and mouthpiece are applied in part

PREPARING THE NEBULIZER FOR USE

1. At normal use, place the device on a stable, sturdy and flat surface horizontally, such that the unit can be easily reached when you are seated.
2. Make sure that the unit is in the “off” (O) position by pressing on the right side of the switch.
3. Insert the power plug into the electrical outlet.
4. Rotate the inhalation top counterclockwise to remove the inhalation top from the medication tank.
5. Add the correct amount of prescribed medication to the medication tank.
6. Turn the inhalation top clockwise until securely closed.
7. Attach the desired inhalation accessory.

ATTACHING THE AIR TUBE

1. Push one end of the air tube onto the air connector of the compressor.
2. Push another end of the air tube onto the air connector on the bottom of the nebulizer kit.

CAUTION:

• Inspect the compressor (main unit) and the nebulizer parts each time before using the device.
• Make sure no parts are damaged, the nozzle and air tube are not blocked and the compressor operates normally.
• Clean and disinfect the nebulizer kit and optional masks before using them for the first time after purchase.
• If the device has not been used for a long period, please clean and disinfect the nebulizer kit and optional accessories before using them.
• To prevent the risk of cross-infection, different persons should never use the same nebulizer kit.
• Do not add more than 10 ml of medication to the nebulizer cup.
• Place the device at least 10cm (4″) distance from the walls.
• Make sure that the nebulizer kit is correctly assembled, the air filter is properly installed, and the air tube is correctly connected to the compressor and the nebulizer kit. Air may leak from the air tube during use if not securely connected.

USING THE DEVICE

1. Switch on the power.
2. The device begins to nebulize.
3. Perform aerosol therapy.
4. Press the 1/O button to safely terminate the operation when the nebulizer kit no longer generates aerosol.
5. Unplug the power cord from the electrical outlet after using the device.

USING THE CHILD MASK or ADULT MASK (OPTIONAL)
Place the mask over the nose and mouth. Pull the elastic strap over the head. Gently pull on the strap to securely hold the mask over the nose and mouth. Inhale the medication. Exhale normally through the mask.

CAUTION

• The patient and operator must keep a distance from the device within 20 cm (8″) to 50 cm (20″) in normal use
• Do not tilt the nebulizer kit so the angle of the kit is greater than 45°. Medication may flow into the mouth.
• Hold the device as upright as possible and do not shake it while in use.
• After the device is moved from an environment where the temperature is too high or too low, it can be used directly without waiting.

CLEANING AND DISINFECTING

The nebulizer kit and the accessories used must be cleaned thoroughly after each application and disinfected at least once a day. The air tube does not need to be cleaned or disinfected. If condensation occurs in the air tube, please clear it as follows

PREPARATION

1. Remove the accessory (mask or mouthpiece) from the nebulizer kit.
2. Detach the air tube from the nebulizer kit.
3. Dismantle the nebulizer kit into its parts.
4. Make sure that all medication residues are removed from the nebulizer kit.
5. Rinse all parts of the nebulizer cup and accessories under running tap water. This must be done especially thoroughly if cleaning and disinfection are not carried out straight away.

CARE OF THE AIR TUBE

1. Connect the air tube to the compressor.
2. Switch the compressor on.
3. Leave the compressor running until any condensation in the tubing has been removed by the air flowing into the tube.

CLEANING

1. Place all disassembled parts in warm tap water (40 C~50 C/104’F 122°F) for at least 10 min. If necessary, use a clean brush to remove loose dirt (the brush must be reserved exclusively for this purpose).
2. Rinse all parts thoroughly in running water (the water flow should be more than 3 litres (0.75 Gallons) per minute ) and each part for at least 1 min.
3. Whether disinfect immediately or not, dry all parts with a new medical gauze. You can remove excess water more quickly by shaking them.

DISINFECTING

After cleaning, disinfect the dismantled nebulizer kit and accessory used (except for the air tube). Effective disinfection is only possible if the nebulizer kit and accessory have been cleaned. Use 2.0% (w/w) Hydrogen Peroxide solution to disinfect the nebulizer kit and accessories. To ensure safety when handling chemicals, follow the instructions for the use of the disinfecting agent, particularly the accompanying safety instructions.

For complete disinfection of the nebulizer kit and accessories, thoroughly clean, rinse and rough dry surfaces before being immersed in chemical disinfection solution.

1. Place all pre-cleaned, rinsed and dried disassembled components in undiluted 2.0% (w/w) Hydrogen Peroxide solution. Ensure that all components’ surfaces have been in full contact with a solution.
2. Once all components have been immersed and all surfaces in contact with the disinfectant solution, soak all components for 8 minutes. Track the soak time using a timer.
3. Rinse all components with sterile water or potable tap water.
4. Dry the parts with a new medical gauze as soon as disinfection has finished. You can remove excess water more quickly by shaking them.
5. Dispose of the used solution.

CAUTION

• As with any plastic parts, nebulizer kit and their accessories are affected by a certain amount of wear and tear when used and hygienically prepared frequently. Over time, this can lead to a change in the aerosol, which can hurt the efficiency of the treatment. We therefore recommend that you replace the nebulizer kit and other accessories every 6 months.
• Ensure to remove the plug before cleaning and disinfection.
• A damp environment may encourage the growth of bacteria. Therefore, dry the parts with a new medical gauze as soon as disinfection has finished. The risk of infection is reduced when the parts are dried.
• Inadequate disinfection encourages the growth of bacteria and thus increases the risk of infection. Adequate cleaning with disinfection can only be assured if application time are adhered to and if all individual parts are completely immersed in the solution for the entire application time. There must not be any cavities or air bubbles.
• Do not place or attempt to dry the device, components or any of the nebulizer parts in a microwave oven.

CARING FOR THE DEVICE

To keep your device in the best condition and protect the unit from damage follow these directions:

CLEANING THE COMPRESSOR
Clean the casing of the main unit by using a soft cloth moistened with water or a mild detergent. Do not use abrasive cleaners. Dry the casing immediately using a soft clean cloth.

CHANGE THE AIR FILTER
Change the air filter every 60 days even if the air filter does not appear dirty. If the air filter appears dirty, or if water or medication has spilled on the air filter, replace it with a new air filter immediately.

1. Pull the air filter cover to remove from the front side of the compressor.

2. Remove the dirty filter with your hand.
   CAUTION Do not attempt to wash or clean the air filter. Damp air filters can cause blockages. Do not substitute cotton or any other material for the air filter.
   CAUTION Wash the air filter cover regularly to prevent any blockage in the cover. Do not boil. Make sure the cover is dry before inserting the new air filter.

3. Insert a new air filter into the air filter cover.
   CAUTION Before inserting the new air filter make sure the air filter is clean and free of dust. Do not operate the device without the air filter.

4. Put the air filter cover back on the compressor.

5. Do not maintain or service the device while it is in use.

STORING THE DEVICE

Wash the nebulizer parts after each use. Drying the parts immediately after washing. Store the device and all parts only in a completely dry and empty state in _a dry and clean location.
WARNING Keep the device out of the reach of unsupervised infants and children. The device may contain small parts that can be swallowed. Do not carry or leave the nebulizer with medication in the medication tank.
CAUTION Do not store the device with a creased or twisted air tube.

TROUBLESHOOTING

CLASSIFICATION

• Equipment Classification concerning protection from electric
• shock: CLASS II
• Degree of protection from electric shock: TYPE BF
• The degree of protection against ingress of water is rated as IPX1.
• Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide.
• Intermittent operation: 20minutes ON, 40minutes OFF

PERIODIC SAFETY CHECKS

Preventive inspection and maintenance to be performed including the frequency of such maintenance

1. Please clean the plug of the power cord at least once a year. Too much dust on the plug may cause a fire.
2. The following safety checks should be performed at least every 24 months by a manufacturer’s engineer who has adequate training. knowledge, and practical experience to perform these tests.
3. Inspect the equipment and accessories for mechanical and functional damage.
4. Inspect the safety-relevant labels for legibility.
5. Inspect the fuse to verify compliance with rated current and breaking characteristics.
6. Verify that the device functions properly as described in the instructions for use.
7. Test the enclosure leakage current according to IEC 60601-1 Limit: NC 100 uA, SFC: 500uA.
8. Test the patient leakage current according to IEC 60601-1 Limit: for a.c.: 100 uA, for d.c.: 10 uA.
9. Test the patient leakage current under single fault conditions according to IEC 60601-1 Limit: for a.c.: 0.5 mA, for D.C.:50uA.

The leakage current should never exceed the limit. The data should be recorded in an equipment log. If the device is not functioning properly or fails any of the above tests, the device has to be repaired.

SPECIFICATIONS

NOTE
Please note that specifications may vary with the medication type used.

WARNING
Oxygen or oxygen mixtures(02>23%) should not be used as driving gas.

AEROSOL PROPERTIES Measurements were performed using a sodium fluoride solution with a “Marple Personal Impactor”.

PLOT OF CUMULATIVE SIZE DISTRIBUTION

NOTE This diagram may not be applicable for suspensions or highly viscous medicines. More information can be obtained from the relevant medicine manufacturer.

Guidance and manufacture’s declaration – electromagnetic emissions-for all EQUIPMENT and SYSTEMS
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.
• 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.”
• 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 NEB-36555, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.”
• Under the test conditions specified in Immunity, the product can provide basic safety and essential performance.
• The Emission characteristics of this equipment make it suitable for use in a home healthcare environment (CISPR11 Class B).

Compliance information for each EMC test

NOTE : The EUT is the a.c. mains voltage before application of the test level.
The following phenomenon still fulfills the requirement of basic safety and essential performance.

1. UT:230V~/50Hz, The pressure of the EUT is deviation from the normal value but the value is still more than 10psi when the flow is 4.5/min.
2. UT:230V~/50Hz, The EUT stop working when adding 0% UT, but the EUT can restore its normal mode automatically.

Note * – As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be the worst case.
Note** – The carrier shall be modulated using a 50 % duty cycle square wave signal.

MATERIAL COMPATIBILITY
There is no specific unusual risk associated with the compatibility between the materials of the component and the dispensed liquid. The material used in the nebulizer kit is not compatible with solution/suspension/emulsions that have not been evaluated. The phthalates conform with the European regulation of REACH.

DEVICE DISPOSAL INFORMATION
Dispose of the device, components and optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution.

5-Year Limited Warranty

Zewa provides a 5-year limited warranty on this product to be free from defects in material and workmanship only under normal use. This warranty extends only to the original owner. For warranty claims, please return the product together with satisfactory proof of purchase such as a sales receipt. Be sure to include your return address, phone number and a brief description of the problem and mail it to:

Zewa, Inc. Attn: Returns Department 12960 Commerce Lakes Drive # 29 Fort Myers, FL 33913

Include a check for return shipping and insurance. Contact Zewa (US and Canada only) at 1-888-993-3592 for appropriate shipping and insurance costs.

Instead of return of the product, Zewa offers a free-of-charge warranty repair service on all defective subassemblies, provided the product fails to perform due to faulty workmanship or faulty materials. Defects on the product due to normal wear and tear, misuse, abuse, improper handling whether negligent or intentional, failure to follow instructions or alterations and repairs of the product other than by an authorized Zewa Service location will void this warranty.

All other repair services not covered under this warranty will be charged to the customer.
Zewa will either repair or replace any parts necessary (at its option) to correct defects in the materials or workmanship. Any replacement parts or products may be new or refurbished.

The above warranty is complete and exclusive. Except as stated above, Zewa makes no express or implied warranties or representations, including, but not limited to the accuracy or completeness of information delivered to you, or warranties of fitness for a particular purpose, intended use, merchantability, non-infringement, or any implied warranties arising out of a course of performance, dealing, or trade usage and we specifically disclaim such warranties. In no event will Zewa be liable for indirect, exemplary, incidental special or consequential punitive or similar damages, including without limitation, any damages resulting from loss of use, loss of business, loss of revenue, loss of profits, or arising in connection with this warranty or your purchase or attempt to purchase products, or of any other obligations, even if we have been advised of the possibility of such damages. Further, the aggregate liability (whether claims arise in contract, personal injury, product liability or otherwise) of – Zewa (and its officers, directors, employees, agents, representatives and affiliates), – and your sole and exclusive remedy, arising concerning or in connection with this warranty, shall not exceed the aggregate of our invoiced purchase price concerning any products to which there is a dispute. The foregoing limitation of liability shall apply regardless of the cause of action under which such damages are sought, whether in contract, in tort or otherwise.

This warranty gives you specific legal rights, and you may have other rights, which vary from state to state. For this warranty to be effective the enclosed registration card must be completed and returned to us within 15 days from the date of purchase. This warranty registration is also available online at www.zewa.com. Any failure to return the registration card to Zewa timely will constitute a complete bar to any claim by you with respect to such product. Any failure to make a timely claim concerning the cuff will also bar your claim Unauthorized returns will be returned to you at your expense and need not be accepted by Zewa.

For any questions regarding this warranty, please contact us By Phone Toll- Free at 1-888-993-3592
Manufactured for Zewa, Inc. 12960 Commerce Lakes Drive # 29 Fort Myers, FL 33913 USA www.zewa.com
Toll-Free Customer Service 1-888 993 3592 warranty@zewa.com

The manufacturer reserves the right to make technical changes without notice in the interest of progress. Prior notices will not be given in case of any amendments within this manual. The mentioned trademarks and names are owned by the corresponding companies.

References

• Zewa Medical Technology

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