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CONTENTS Before Using the Device Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Know Your Unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Before Using the Device Introduction Thank you for purchasing the OMRON NE-C801 Compressor Nebulizer. Fill in for future reference. DATE PURCHASED:___________________ SERIAL NUMBER:_____________________ • Staple your purchase receipt here • Register your product on-line at www.register-omron.com This product was developed for the successful treatment of asthma, allergies and other respiratory disorders. The compressor forces air to the nebulizer.
Intended Use The NE-C801 Compressor Nebulizer System is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The system is designed for use with pediatric (defined by the prescribed medication) and adult patients in the home, hospital, and sub-acute settings. All warnings and cautions described in this manual should be observed. 4 NE-C801S-Z_A_M_E_SP_082411.
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. SAFETY SYMBOLS USED IN THIS INSTRUCTION MANUAL WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
Safety Information OPERATING THE DEVICE (continued) Do not operate where oxygen is being administered in a closed environment (such as an oxygen tent). 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. When using the device, the main unit may become hot.
Safety Information OPERATING THE DEVICE (continued) Dispose of the device, components and optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution. Use only Omron 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 Omron Healthcare will void the user warranty.
Safety Information Risk of Electrical Shock (continued) Do not overload power outlets. Plug the AC adapter into the appropriate voltage outlet. Do not use extension cords. Plug the AC adapter directly into the electrical outlet. Unplug the AC adapter from the electrical outlet after using the device. Remove the AC adapter from the device after use. Unplug the AC adapter from the electrical outlet before cleaning the device. Do not pull the power cord of AC adapter strongly.
Components and Replacement Parts Know Your Unit Nebulizer Kit Compressor (Main Unit) Nebulizer Kit Holder Air Tube Plug Air Tube Connector Air Tube Plug Power Switch Back View Air Tube (PVC, 100 cm) NOTE: Only use the NE-C801 Nebulizer Kit with this Nebulizer. Air Filter Cover *Air filter inside Power Connector Nebulizer Kit Cap Mouthpiece Inhalation Air Inlet Inhalation Top Baffle Nozzle Medication Cup Air Tube Connector 9 NE-C801S-Z_A_M_E_SP_041311.
KNOW YOUR UNIT Components: Air Filters Package of 5 Instruction Manual Storage Bag INSTRUCTION MANUAL Compressor Nebulizer Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or licensed healthcare practitioner ENGLISH ESPAÑOL NE-C801 AC Adapter Terminal Power Cord Power Plug Accessories and Replacement Parts Model No. AC Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Adult Mask (PVC). . . . . . . . . . . . . . .
Operating Instructions Preparing the Nebulizer for Use WARNING • Clean and disinfect the nebulizer kit, mouthpiece, and optional nosepiece or optional masks before using them for the first time after purchase. • If the device has not been used for a long period of time, or if more than one person uses the same device, clean and disinfect the nebulizer kit, mouthpiece, and optional nosepiece or optional masks before using them. CAUTION ake sure the air filter is clean.
PREPARING THE NEBULIZER FOR USE 3 Rotate the inhalation top counterclockwise (A) and lift (B) to remove the inhalation top from the medication cup. 4 Add the correct amount of prescribed medication to the medication cup. WARNING • For type, dose, and regime of medication follow the instructions of your physician or licensed healthcare practitioner. • Do not spill water or other liquids on the compressor and AC adapter. These parts are not waterproof.
PREPARING THE NEBULIZER FOR USE 7 Attach the desired inhalation accessory. USING THE MOUTHPIECE Place the cap on the medication cup over the inhalation air inlet (A). Attach the mouthpiece (B). NOTE: Place the cap on the medication cup when using the mouthpiece. Using the cap with the mouthpiece will reduce the amount of medication that is discharged into the air. USING THE NOSEPIECE (Optional) Place the cap on the medication cup over the inhalation air inlet (A). Attach the nosepiece (B).
Attaching the Air Tube 1 Twist the air tube plug slightly and push it firmly into the air tube connector on the upper side of the compressor (A). 2 Twist the air tube plug slightly and push it firmly into the air tube connector on the bottom of the nebulizer kit (B). NOTE: Keep the nebulizer kit upright when attaching the air tube. Medication may spill out of the medication cup.
Using the Device WARNING • Do not use the device where the device may be exposed to flammable gas or vapors. • Do not use or store the device in humid locations, such as a bathroom. Use the device within the operating temperature and humidity. CAUTION • Provide close supervision when this device is used by, on, or near infants, children or compromised individuals. • Do not use a cellular phone near the device. It may result in an operational failure.
USING THE DEVICE CAUTION • Do not block the air filter cover. • Limit use to 20 minutes at a time, and allow a 40 minutes interval before using the device again. • When using the device, the main unit may become hot. • Do not touch the main unit for other than necessary operation such as turning off the power while nebulizing. 3 Inhale medication as instructed by your physician or licensed healthcare practitioner. USING THE MOUTHPIECE Insert the mouthpiece into your mouth.
USING THE DEVICE 5 Turn the power switch to the off ( ) position. The compressor turns off and nebulization stops. 6 Disconnect the air tube from the nebulizer kit. Hold the air tube plug and gently pull down to disconnect the air tube plug from the air tube connector on the bottom of the nebulizer kit. 7 Check the air tube. No condensation or moisture should remain in the air tube. WARNING o not store the air tube with moisture or medication remaining in the air tube.
Care and Maintenance Cleaning after Each Use Following cleaning instructions after each use will prevent any remaining medication in the bottle from drying resulting in the device not nebulizing effectively and will help prevent infections. WARNING Wash the nebulizer parts after each use. Dry the parts immediately after washing. 1 Remove the inhalation accessory (mouthpiece, optional masks, or optional nosepiece) from the nebulizer kit. 2 Disconnect the air tube from the nebulizer kit.
Daily Disinfecting Disinfect the nebulizer kit and mouthpiece, or optional masks or optional nosepiece after the last treatment of the day. To disinfect the parts, use one of the methods described below: A. Use a commercially available disinfectant. Follow the instructions provided by the disinfectant manufacturer. 1 Submerge the parts in the cleansing solution for the specified period. 2 Remove the parts and discard the solution.
Changing the Air Filter If the air filter has changed color or has been used on average for more than 60 days, replace it with a new one. If water or medication has spilled on the air filter, replace with a new air filter immediately. 1 Pull the air filter cover to remove from the back side of the compressor. 2 Remove the dirty air filter. 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.
Caring for the Device To keep your device in the best condition and protect the unit from damage, follow these directions: CAUTION • Do not subject the compressor or any of the components to strong shocks, such as dropping on the floor. • Use only Omron 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.
Troubleshooting Troubleshooting Guide PROBLEM No power to unit when the power switch is on. No nebulization or low nebulization rate when the power is on. The device is abnormally loud. Cause SOLUTION The AC adapter is not plugged into an electrical outlet. Turn the power switch off. Plug the AC adapter into an electrical outlet. Turn the device on. No medication in the medication cup. Too much or too little medication in the medication cup.
Limited Warranty Your OMRON NE-C801 Compressor Nebulizer, excluding the nebulizer kit, inhalation accessories, air tube and air filters, is warranted to be free from defects in materials and workmanship appearing within 3 years from the date of purchase, when used in accordance with the instructions provided with the compressor nebulizer. The above warranties extend only to the original retail purchaser.
FCC STATEMENT NOTE: POTENTIAL FOR RADIO/TELEVISION INTERFERENCE (for U.S.A. only) This product has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
Specifications Model: NE-C801 (NE-C801S-Z) Type: Compressor nebulizer Rating (AC adapter): 100 - 240V ~ 350mA, 50/60 Hz Rating (Compressor Nebulizer): 12V 0.8A Nebulization Rate: Approx. 0.3 mL/min (without cap) Particle Size: *MMAD approx. 3 μm (based on EN13544-1:2007) Medication Cup Capacity: 7 mL (cc) max. Appropriate Medication 2 mL - 7 mL (cc) Quantities: Operating Condition: Intermittent operation 20 min. ON/40 min.
Technical Data Particle Specifications A series of aerosol performance tests were performed using an 8 stage cascade impactor at a sampling flow rate of 15 l/min equipped with a USP <601> induction port throat. Aerosol was sampled directly from the outlet. Three (3) device samples were tested with 3 runs each, for a total of 9 sample points per each drug. The specifications are listed below with intervals given for a 95% confidence level.
Guidance and Manufacturer's Declaration Important information regarding Electro Magnetic Compatibility (EMC) With the increased number of electronic devices such as PC’s and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation. Medical devices should also not interfere with other devices.
Guidance and Manufacturer's Declaration Electromagnetic immunity IEC60601-1-2 Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply IEC 61000-4-11 IEC 60601 Test level Compliance level ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air ±2 kV for power supply lines ±1 kV for input/output lines ±1 kV line to line ±2 kV line to earth <5 % UT (>95 % dip in UT) for 0
Guidance and Manufacturer's Declaration Electromagnetic immunity IEC60601-1-2 IEC 60601 Test level Compliance level Conducted RF IEC 61000-4-6 3 V rms 150 kHz ~ 80 MHz 3 V rms Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.
Guidance and Manufacturer's Declaration Recommended separation distance between portable and mobile RF communications equipment and the NE-C801 The NE-C801 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
NE-C801S-Z_A_M_E_SP_041311.
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