Nebu 100s Series Instruction Manual Pioneer Medical Instrument Technology (PMI) Co.,Ltd. 7F., No.11, Wuquan 2nd Rd., Wugu Dist., New Taipei City 248, Taiwan R.O.C.) http://www.pmi med.com e Mail: customer.service@pmi med.com
PMI MICROMESH NEBULIZER Model: Nebu 100s Product Instruction This nebulizer atomizes liquid (normal saline), and sprays it into the user s airway in order to keep the respiratory tract unobstructed, moisten respiratory tract, and dilute sputum. Intend for use For adult and pediatric patients suffering from asthma or Chronic Obstructive Pulmonary Disease (COPD) such as; emphysema and chronic bronchitis, or other respiratory diseases that are characterized by obstruction to air flow. Thank you for purchasing this product. Please read the instruction manual carefully before use. Please keep this instruction manual at a convenient place for future references. This is a single patient device. Do not allow multiple patients to use the same nebulizer.
Contents Before Use Safety Instruction.. 1 Product Specifications Product Specifications List.. 3 Components. 4 Components Names & Functions. 5 Usage How to assemble the nebulizer 6 How to operate the nebulizer 11 Cleaning and Storing How to clean the nebulizer. 13 How to store the nebulizer.. 15 Notice Option Accessories 17 Troubleshooting.. 19 Note. 21 Explanation of Symbols.. 29
Safety Instruction Warning This medical device is designed for using clean water or normal saline (physiological salt solution) only. Please follow a doctor s instructions when choosing the treatment interval, dosage, and regimen. Do not place any liquid in the medication cup that is not prescribed by a licensed physician. This is a single patient device. Do not allow multiple patients to use the same device. If you are using the nebulizer for the first time after purchasing it or if you have not used it for a long time, please clean the nebulizer parts. (Please see pages 13 to 14) After each use, please clean the necessary nebulizer parts, (such as medication cup, mask, etc.) with clean water. Dry the cleaned parts immediately and store in a clean environment. (Please see page 13 to 16) Do not immerse (wash) the main unit of the nebulizer in water, please use dry cotton cloths to clean directly. The trachea or bronchial will be irritated by sprayed particles and may lead cough or choking. 1
Caution Please clean the nebulizer parts carefully after each use. Otherwise it may not fulfill its function. Avert severe impact with the nebulizer. Otherwise it may not fulfill its function. Do not use the nebulizer to the unconscious patients. Do not use the nebulizer with increased pulses or cardiac irritability. Do not store nebulizer with liquid medication or water still remaining in the medication cup. Do not fill the medication cup over 8 ml, otherwise it may risk overflow. Do not submerge the main nebulizer unit in water. Do not drop the nebulizer. Please remove the battery if you do not intend on using the nebulizer for a while. Keep the device out of the reach of infants and children. Children should only use the device while under adult supervision. 2
Product Specifications List Name PMI micromesh nebulizer Model Nebu 100s Method of Operation Ultrasonic (Atomize by Micromesh) Size Approx. 26mm ( L ) x 35mm ( W ) x 98mm ( H ) Weight Approx. 48g (Excluding battery) Power 3V DC (Two AAA 1.5V alkaline batteries) Power Consumption Approx. 0.6 W Vibrating Frequency Approx. 117 khz Spray rate Up to 0.25 ml/min Particle Size Capacity Battery Life Expected Service Life Operating Conditions Storage / Transportation Conditions Accessory MMAD < 5μm Approx. 8 ml Maximum Approx. 1 ml Minimum Up to 2.5 hours if used continuously. 10 days if used daily for 15 minutes. (with two 1.5V AAA alkaline batteries) Nebulizer main unit: 1 Year Medication Cup: 3 months (In normal use) 10 ~ 40 (50 ~ 104 ), 30 ~ 85% R.H. 20 ~ 70 ( 4 ~ 158 ), 85% R.H. main unit (Include battery cover) x 1 medication cup ( Include the cup lid) x 1 nozzle cap x 1 mask (L) for adult x 1 mask (S) for child x 1 10mL measuring cup x 1 alkaline battery ( AAA 1.5V) x 2 zippered pouch x 1 Instruction Manual x 1 3
Components The package contains the following components. If any components are missing, please immediately contact the retailer from which the product was purchased from. Main Unit Medication Cup Alkaline Battery AAA 1.5V x 2 Nozzle Cap Mask (L) Mask (S) 10mL Measuring Cup Zippered Pouch 4
Components Names & Functions 5
How to assemble the nebulizer Please clean and dry the nebulizer s parts before use 1. Attach / Remove the medication cup to the main unit: Mount the medication cup. The medication cup should be secured with a click upon attachment. Press down on the safety lock on the side of the main unit and pull the medication cup out toward the front of the main unit. Caution Please ensure that the medication cup is attached correctly; otherwise, it may result in a bad connection and the nebulizer may not perform properly. Users can check the safety lock on the side, or pull at the medication cup to test if it is secured. 6
2. Attach the inhalation mask: Attach the mask to the nozzle. Then ensure that the direction is correct and the mask is fitted all the way to the bottom of the nozzle. Caution There are two sizes of masks available for adults and children, please select the correct size before installation. Mask (L) Mask (S) 7
3. Battery Installation a. Please push the battery cover down and then insert two AAA alkaline batteries as indicated by the positive and negative battery contacts. b. Close the battery cover of the main unit to complete the installation. Caution For using 15 minutes in each treatment, 2 batteries can be used for 10 times. The low power indicator is indicated by the LED blinking red (interlaced flicker), suggesting batteries replacement. 8
4. Fill the medication a. Please remove the medication cup and open the cup lid, then fill the medication cup with the normal saline (fill with inappropriate drugs may lose the warranty) as shown in the diagram. b. Please close the lid of the medication cup then remount the cup back to main unit. 9
Caution Recommended fill volume: Approx. 8 ml maximum / 1 ml minimum. (Otherwise it may not fulfill its function) This medical device is designed for using clean water or normal saline (physiological salt solution) only. Please follow a doctor s instructions when choosing the treatment interval, dosage, and regimen. Do not place any liquid in the medication cup that is not prescribed by a licensed physician. 10
How to operate the nebulizer After filling the medication, Press the power button to activate it, if you wish to halt the treatment, press the button again to turn the power off. The LED indicator instructions are as follows: 1. Both LED lights off: main unit powered off. 2. Blue LED light on and red LED light off: Spraying operations have commenced. 3. Red LED light on and blue LED light off: an error has occurred, the main unit will power off automatically after 10 seconds. 4. Blue LED light on and red LED blinking during operation: the battery is nearly exhausted. During operation, please grasp the main unit in your hand and put on the mask covering the nose and latch nozzle, and start inhaling as normal. 11
Caution If the cup lid screwed too tightly, the spray may be decreased by the vacuum effect. Do not screw the cup lid too hard. If the nebulizer is unable to spray out, please go to page 19 to 20 for troubleshooting. The medication cup is expendable, and the suggested lifetime of the mesh is approximately three months, depending on the medication. If the Medication cup still cannot be used after cleaning, please replace it with a new one. 12
How to clean the nebulizer Straight after each use, make sure to clean the nebulizer with the clean water and a wet piece of gauze and lightly wipe off the stains on the main unit, before storing or carrying. The cleaning instructions are as follows: 1. Clean the remaining medication, open the cup lid of the medication cup and discard the remaining medication. 2. After flushing the inside of the medication cup by clean water, lightly wipe off the surface. Then pour a small amount of clean water (2 ~ 3mL) into the medication cup and close the lid. 3. Press the power button to active the device start to nebulize (to remove the residual medication in the medication cup) until the liquid is depleted. 4. Remove the medication cup on the main unit. To clean the medication cup, cup lid and inhalation mask with clean water (exclude the nebulizer main unit). 5. If there is dirt or residual liquid in the main unit, please wipe it off before storage. 13
Caution If the mesh is clogged or dirty, please remove the residual medication firs. Then flush or soak it in water to clean it. If the main unit is dirty, please wipe it with a wet cotton cloth. (Do not wash the main unit in water directly) Please do not clean the nebulizer and other parts with an organic solvent or volatile liquid such as benzene or thinner. After cleaning, attach the nozzle cap back on, and store all parts in a clean environment. 14
How to store the nebulizer 1. Remove the mask from the medication cup 2. Re attach the cap to the nozzle of the medication cup. 3. Remove the battery, if you do not intend on using the nebulizer for a while. 4. When you need to take the nebulizer out, keep all accessories and the nebulizer in the pouch. 15
Caution Please do not store a nebulizer that still contains medication or water. The liquid may leak out and damage or stain the unit. Do not store the nebulizer when the power is turned on. Do not store the nebulizer in an area with high temperature or humidity, or in direct sunlight. 16
Optional Accessories Accessories / Optional parts are shown below. If you wish to purchase any of them, please contact the retailer which you purchased the nebulizer from. Medication Cup Nozzle Cap Nebu 100s MC01 Mask (L) Nebu 100s NC01 Mask (S) Nebu 100 ML01 Nebu 100 MS01 17
Zippered Pouch Nebu 100 CB01 18
Troubleshooting Please refer to the table below to troubleshoot any problems you may encounter when using the nebulizer. Problems Possible Causes Solutions Power indicator blue light on, but extremely low or no mist. Medication cup s mesh is clogged up. Medication cup is dirty Electrodes on the medication cup is dirty Medication cup is not completely attached. The consistency of liquid is too high in the medication cup. Turn off the unit and remove the residual medication first. Then flush or soak it in water to clean it. (exclude the main unit) Remove the medication cup. Use a clean cotton swab with alcohol (95%) to wipe the electrodes at the bottom of the cup, and restart the power again. Re attach the medication cup correctly and restart the power. (Jiggle the cup to ensure the safety lock is completely latched) Please follow the instruction to elect the liquid (As normal saline) The medication cup s mesh has expired. Replace with a new medication cup. 19
Problems Possible Causes Solutions Power indicator does not light up and nebulizer does not operate. Power indicator red light on Stops functioning during usage (No LED light). The liquid is overflowing from the medication cup. Low battery power. Batteries installed in reverse directions, or the battery is not in contact. The medication cup doesn t attached correctly The Mesh is clogged, and the frequency scanning function isn t complete. Low battery. The cap did not cover the cup. The O ring under the cup lid of the medication cup is out of life. The O ring under the medication cup nozzle is out of life. The medication cup is broken. Please replace with new batteries and restart the power. Re install the batteries in the correct orientation and restart the power. Please ensure that the medication cup is attached correctly then restart the power. Clean the mesh by flushing clean water and restart the power again. Please replace with new batteries. Re screw the cap lock Replace with a new medication cup. 20
Note Consult the instructions for use If the unit is used outside of the specifications, proper function is no longer guaranteed! We reserve the right to make technical changes to improve and further develop the product. Expected Service Life and Repairs By the reliability test and the function decay of electronic component, the expected service life on nebulizer main unit is one year. Since the medication cup is an expendable item, the expected service life is three months. Performance standards EN 13544 1: Respiratory therapy equipment part1: nebulizing systems and their components. All measurements were obtained with a sodium fluoride (NaF) 2.5% (M/V) in distilled water using a personal cascade impactor method. 21
Cumulative particle size distribution During the test of personal cascade impactor method, the aerosol output (ml) is 1.87±0.16 and the aerosol output (ml/min) 0.28±0.02. This diagram may not be applicable for suspensions or highly viscous medicines. More information can be obtained from the relevant medicine manufacturer. 22
Sound Power Level Measurement By the test method: EN 13544 1:2007+A1:2009, A weighted sound pow level (L wa ) is 38.6db, A weighted sound pressure level (L pa ) is 28.1db. IP22 Protected against foreign objects equal to or greater than 12.5 mm in diameter and against drops of water falling at up to 15 from vertical. Electromagnetic Compatibility The device complies with current specifications with regard to electromagnetic compatibility and is suitable for use in all premises, including those designated for private residential purposes. The radio frequencies emissions of the device are extremely low and in all probability do not cause any interference with other devices in the proximity. It is recommended that you do not place the device on top of or close to other devices. Should you notice any interference with other electrical devices, move the unit or connect it to a different socket. Radio equipment may affect the operation of this device. 23
Guidance and manufacturer's declaration Electromagnetic Emissions for PMI Nebu 100s series. 24
Verification of EMC Compliance 25
The Plastic Components in Applied Parts Designation Material REF Nozzle Cap Silicon Nebu 100s NC01 Adult mask PVC Nebu 100 ML01 Child mask PVC Nebu 100 MS01 Medication Cup PC Nebu 100s MC01 Zippered Pouch Nylon, PP, PVC, PET Nebu 100 CB01 Containing particular phthalates The PVC masks and the O Rings in the medication cup contain particular phthalates (Di iso nonyl Phthalate, DINP). Manufacturer Pioneer Medical Instrument Technology Co. Ltd: 7F., No. 11, Wuquan 2 nd Rd., Wugu Dist., New Taipei City 248, Taiwan (R.O.C) Authorized representative in the European Community MedNet GmBh: Borkstrasse 10, 48163 Muenster, Germany. 26
The Batch Code (Main Unit) The code indicates the production batch of Nebu 100s main unit and its applied parts. The batch code is marked on the battery slot of main body or pasted in the packaging bags of each applied parts. Takes AGA as an example, the first letter A indicates the AC chronology started from 2014. The second letter G means the 7 th month of the year and the third letter A shows the first batch of the month. The Serial Code (Medication Cup) The code indicates the production serial of Nebu 100s medication cup. The serial code is marked on the bottom of medication cup, such as AGB0003. According to the batch coding rules, the AGB0003 shows the medication cup produced is the third output of the second batch on July, 2014 Disposal The appliance should be disposed of according to regulation 2002/96/EC WEEE (Waste Electrical and Electronic Equipment). In case of queries, please contact the municipal authorities responsible for waste disposal in your area. 27
Used batteries do not belong in the household waste. You are legally obliged to dispose of the batteries. Dis pose of them via your specialist electrical supplier or local collecting point for recyclable waste. Batteries containing pollutant substances are marked as follows: Pb = Battery contains lead, Cd = Battery contains cadmium, Hg = Battery contains mercury. The batteries for this device do not contain any toxic substances. 28
Explanation of Symbols Item Explanation Consult the instructions for use Symbol for CAUTION Symbol for BATCH CODE The symbol indicates the serial number of medication cup. The symbol indicates the catalogue number of nebulizer main unit. WEEE Symbol WEEE Symbol Symbol for "MANUFACTURER" 29
Item Explanation Authorized representative in the European Community Symbol for Containing particular phthalates Symbol of type of applied part PMI Nebu 100s Instruction Manual EN 1.3 (2017.05.11) 30