Table of Contents Introduction Important Safety Information ..................3 1. Know Your Device 1.1 Contents ......................6 1.2 Names of the Parts ....................7 2. Preparation 2.1 Before Using the Device for the First Time ............8 2.2 Cleaning the Device Before First Use ..............8 2.3 Setting the Device....................10 3.
Introduction Thank you for purchasing the Omron® COMP A-I-R® RE-C800KD. Omron Healthcare has advanced electronic nebulizer technology with the introduction of the COMP A-I-R RE-C800KD. With a focus on patient convenience and compliance as our goal, this small and lightweight device provides a quiet and effective treatment.
Important Safety Information Read the Important Safety Information in this instruction manual before using this device. Follow this instruction manual thoroughly for your safety. Keep for future reference. For specific information about your own device, CONSULT WITH YOUR PHYSICIAN. Indicates a potentially hazardous situation which, if not avoided, could WARNING result in death or serious injury.
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• DO NOT get nebulized medication in your eyes. • DO NOT insert any object into the main unit. • Use ONLY Omron authorized parts and accessories (refer to section 6). Parts and accessories not approved for use with this device may damage the unit.
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• Unplug the AC adapter when not in use. • Unplug the AC adapter before cleaning this device. • Use ONLY the AC adapter designed by Omron for this device (refer to section 6 for optional accessories). Use of any other AC adapter may damage the device.
*Air filter inside Nebulizer Kit Inhalation Top Vaporizer Head Medication Tank Nozzle Air Tube Connector CAUTION • Use ONLY Omron authorized parts and accessories (refer to section 6). Parts and accessories not approved for use with this device may damage the unit.
2. Preparation 2.1 Before Using the Device for the First Time WARNING • Failure to properly clean the COMP A-I-R components may cause bacterial growth, serious illness from contamination, compromised medication delivery. • Clean the parts of this device before using this device for the first time, and also when the device has not been used for an extended period of time.
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2.2 Cleaning the Device Before First Use Wash the parts. Wash in warm water with mild (neutral) detergent Wash the inhalation top, medication tank and accessories (mouthpiece, mask or child accessory) in warm water with mild (neutral) detergent and rinse all pieces thoroughly with clean hot tap Inhalation Medication Mouthpiece...
2.3 Setting the Device Insert the power plug of the AC adapter Main unit into the power connector on the bottom of the main unit. Power plug Plug the AC adapter into the electric outlet. WARNING • Plug the AC adapter into the appropriate voltage outlet. DO NOT use in a multi-outlet plug. •...
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2.3 Setting the Device Attach the vaporizer head securely to the inhalation top. Note The sizes of the left- and right-hand attached parts of the vaporizer head are not the same. If the vaporizer head is not attached in the correct orientation, it will not nebulize correctly.
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2.3 Setting the Device Connect the main unit and nebulizer kit. Attach one end of the air tube to the main unit. Then attach the other end of the air tube to the nebulizer kit. Make sure the air tube plugs are firmly pushed into the air tube connectors. Note Keep the nebulizer kit upright when attaching the air tube.
3. Using Your Device 3.1 Starting Inhalation WARNING • Keep this device out of the reach of unsupervised infants, toddlers and children. This device contains small parts that may cause a choking hazard if swallowed by infants, toddlers or children. •...
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3.1 Starting Inhalation Inhale medication as instructed by your physician or licensed healthcare practitioner. Using Child Mask Place the mask over the nose and mouth. Pull the elastic strap over the head. Gently pull on the strap to secure the mask over the nose and mouth.
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3.1 Starting Inhalation Check the air tube. No condensation or moisture should remain in the air tube. WARNING • After cleaning, allow the parts to dry before reassembling. To avoid contamination, store the device and parts in a clean and safe location. If any condensation or moisture remains in the air tube, remove the moisture from the air tube.
3.2 Cleaning the Device After Each Use The following items should be disassembled and cleaned after each use in order to prevent any remaining medication in the tank from drying which will result in ineffective nebulization. • Nebulizer kit (inhalation top, medication tank and vaporizer head) •...
Insert a new air filter. CAUTION • Use ONLY Omron authorized parts and accessories (Refer to section 6). Parts and accessories not approved for use with this device may damage the unit. • Make sure the air filter is clean. If the air filter has changed color or has been used on average for more than 60 days, replace it with a new one.
3.5 Storing the Device Store the main unit, air tube, nebulizer kit and accessories (mouthpiece, mask and child accessory) in a safe, clean location. WARNING • Keep this device out of the reach of unsupervised infants, toddlers and children. This device contains small parts that may cause a choking hazard if swallowed by infants, toddlers or children.
4. Troubleshooting If any of the below problems occur, check to make sure that no other electrical device is within 12 inches (30 cm). If the problem persists, refer to the table below. Problem Possible cause Solution No power to the unit when The AC adapter is not plugged Press the power switch off.
Applied Part Type BF (mouthpiece, mask) * Measured by OMRON HEALTHCARE Co., Ltd. Measured with saline at ambient temperature of +73 °F (+23 °C) and humidity of 40 %. It may vary with the type of medication. **MMAD = Mass Median Aerodynamic Diameter...
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7. Specifications • IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This device is protected against solid foreign objects of 12.5 mm diameter and greater such as a finger, and against vertically falling water drops which may cause issues during a normal operation. •...
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7. Specifications Particle Specifications A series of aerosol performance tests were performed using an 8-stage cascade impactor at sampling flow rates of 13 l/min and 30 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.
8. FCC Statement FCC CAUTION Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This device complies with Part 15 of FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
PURPOSE. IMPLIED WARRANTIES AND OTHER TERMS THAT MAY BE IMPOSED BY LAW, IF ANY, ARE LIMITED IN DURATION TO THE PERIOD OF THE ABOVE EXPRESS WARRANTY. OMRON SHALL NOT BE LIABLE FOR LOSS OF USE OR ANY OTHER SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT COSTS, EXPENSES OR DAMAGES.
10. Guidance and Manufacturer’s Declaration OMRON RE-C800KD Information for Accompanying Documents in the Scope of IEC60601-1-2:2014 Important information regarding Electromagnetic Compatibility (EMC) RE-C800KD conforms to IEC60601-1-2:2014 Electromagnetic Compatibility (EMC) standard. Further documentation in accordance with this EMC standard is available at...
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