Omron ME-C28P User's Manual
Contents
1. COMP ATR Compressor Nebulizer Model NE C28P Instruction Manual All for Healthcare IM NE C28P E EN 03 01 2013 1675597 9A Intended use Medical Purpose This product is intended to be used for inhaling medication for respiratory disorders Intended User e Legally certified medical experts such as doctor nurse and therapist e Caregiver or patient under the guidance of qualified medical experts for home treatment e The user should also be capable of understanding general operation of NE C28P and the content of instruction manual Intended Patients This product should not be used on patients who are unconscious or are not breathing spontaneously Environment This product is intended for use in a medical facility such as Hospital clinic and doctor s office and in a room of general household Durable period Durable periods are as follows provided the product is used to nebulize saline 3 times a day for 10 minutes each time at room temperature 23 C Durable period may vary depending on usage environment Compressor Main unit 5 years Nebulizer Kit 1 year Mouthpiece 1 year Nosepiece 1 year Air Tube PVC 200cm 1 year Air Filter 60 days Mask PVC SEBS 1 year Precautions for use Warnings and cautions described in the instruction manual should be observed Thank you for purchasing the OMRON COMP AIR This product was developed in conjunction with respiratory therapists for the successful treatm2. or moderate injury or physical damage Usage Provide close supervision when this device is used by on or near children or invalids Make sure that the parts are attached correctly Make sure that the air filter is correctly attached Make sure that the air filter is clean If the air filter has been used for more than 60 days replace it with a new one Do not tilt the nebulizer kit at an angle of greater than 45 degrees in all directions or shake it while in use Do not use or store the device while the air tube is creased Use only original nebulizing parts air tube air filter and air filter cover Do not add more than 7 ml of medication to the medication tank Do not carry or leave the nebulizer kit while the medication tank contains medication Do not leave the device unattended with infants or persons who cannot express their consent Do not subject the device or the parts to any strong shocks such as dropping the device on the floor Do not distort the vaporiser head or jab the nozzle of the medication tank with a pin or any sharp object e Do not insert fingers or objects inside the compressor Do not disassemble or attempt to repair the compressor or power cord Do not leave the device or its parts in extreme hot or cold temperature or under direct sunlight Do not block the air filter cover Do not use the device while sleeping or if drowsy Approved for human use only The compressor may become hot during operat
3. 2 EEC Medical Device Directive and the European Standard EN13544 1 2007 A1 2009 Respiratory therapy equipment Part1 Nebulizing systems and their components e Performance may vary with drugs such as suspensions or high viscosity See drug supplier s data sheet for further details See website of OMRON HEALTHCARE EUROPE to update technical information URL www omron healthcare com
4. afety Precautions Inspect the device and parts before using them each time and check that there are no problems In particular be sure to check the following That the nozzle or air tube are not damaged That the nozzle is not blocked That the compressor operates normally 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 nebulizer kit This is normal and does not indicate a malfunction Operate the device only as intended Do not use the device for any other purpose Do not use the device at temperatures greater than 40 C Make sure that the air tube is securely attached to the compressor and nebulizer kit and does not come loose Twist the air tube plug slightly when inserting it into the air tube connectors to avoid the air tube disconnecting during use To completely isolate the device from the power source unplug the plug from the power source Keep these instructions for future reference 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 a
5. cation This will avoid inefficient nebulization or infection m Washable parts e Nebulizer Kit Mask PVC SEBS Mouthpiece Nosepiece Air Tube Silicone Wash them in warm water and mild detergent neutral detergent Rinse them thoroughly with clean hot tap water and allow to air dry in a clean place E Non washable parts e Compressor Air Tube PVC Firstly make sure that the power plug is unplugged from the power outlet Wipe clean with a soft cloth moistened with water or mild detergent neutral detergent e Air Filter Do not wash or clean the air filter If the air filter becomes wet replace it Damp air filters can cause blockages Disinfecting Always disinfect the parts after the last treatment of the day If the parts are heavily stained replace them with new ones To select a method for disinfection refer to the table below O applicable X not applicable Adult Mask SEBS optional Child Mask SEBS Silicone 100cm optional Mouthpiece Nosepiece Nebulizer Kit Air Tube optional Adult Mask PVC Child Mask PVC Air Tube PVC 200cm Air Filter Disinfecting method Materials Vaporiser Head PC Tube Silicone Connector PP Mask SEBS Band Rubber non latex Adapter PP Mask PVC Phthalate free Band Rubber non latex Phthalate free Polyester Alcohol Disinfecting ethanol Sodium hypochlorite Quaternary ammonium Hibi
6. e new air filter 3 Put the air filter cover back in place Make sure it is attached properly Notes e Use only OMRON air filters designed for this device Do not operate without a filter Do not wash or clean the filter If the air filter becomes wet replace it Damp air filters can cause blockages e There is no front or back orientation for the air filters e Check that air filters are clean and free of dust before inserting them Troubleshooting Check the following if the device should fail during operation Cause Problem Remedy Nothing happens when the power switch is pressed he power plug plugged into a power outlet Check that the plug is inserted in a power outlet Unplug then reinsert the plug if necessary Add the correct amount of medication to the medication tank here medication in the dication tank No nebulization or low nebulization rate when the power is on here too muchilittle dication in the medication k he vaporiser head missing not assembled correctly Attach the vaporiser head correctly Assemble the nebulizer kit correctly he nebulizer kit assembled rectly Make sure that the nozzle is free of blockages he nozzle blocked Make sure that the nebulizer kit is not tilted at an angle of more than 45 degrees Is the nebulizer kit tilted at a sharp angle Make sure that the air tube is correctly connected to the compressor and n
7. ebulizer kit he air tube connected rectly Make sure that the air tube does not contain kinks he air tube folded or maged Make sure that the air tube is free of blockages he air tube blocked he air filter dirty Replace the air filter with a new one he air filter cover attached rectly The compressor is abnormally loud Attach the air filter cover correctly The compressor is very hot he compressor covered Do not cover the compressor with any type of cover during use Are the ventilation slots Do not block the ventilation slots blocked Note If the suggested remedy does not solve the problem do not try to repair the device no parts of the device are user serviceable Return the device to an authorized OMRON retail outlet or distributor Technical data Name Model Type Rating Power Consumption Operating Temperature Humidity Storage and Transport Temperature Humidity Air Pressure Weight Dimensions Contents Classification Class ll o equipment O Power off R Type B applied part COMP AIR NE C28P NE C28P E Compressor Nebulizer 220 240V 50 60Hz 192VA 10 C to 40 C 30 to 85 RH 20 C to 60 C 10 to 95 RH 700 1060hPa Approx 1 9kg compressor only Approx 170 W x 103 H x182 D mm Compressor Nebulizer Kit Air Tube PVC 200cm Mouthpiece Nosepiece Adult Mask PVC Chi
8. ent of asthma chronic bronchitis allergies and other respiratory disorders This is a medical device Operate the device only as instructed by your doctor and or respiratory therapist Baffle How the nebulizer kit works Aerosol Aerosol The medication that is pumped up through the medication channel is Nozzle mixed with compressed air which is generated by a compressor pump The compressed air mixed with medication is turned into fine particles and sprayed when in contact with the baffle Medication Channel Medication Medication Compressed Air Manufacturer OMRON HEALTHCARE Co Ltd J 53 Kunotsubo Terado cho Muko Kyoto 617 0002 JAPAN EU representative OMRON HEALTHCARE EUROPE B V Scorpius 33 2132 LR Hoofddorp THE NETHERLANDS spe www omron healthcare com Production facility OMRON DALIAN CO LTD Dalian CHINA OMRON HEALTHCARE UK LTD Opal Drive Fox Milne Milton Keynes MK15 ODG U K Subsidiary OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH John Deere Str 81a 68163 Mannheim GERMANY www omron medizintechnik de OMRON SANTE FRANCE SAS 14 rue de Lisbonne 93561 Rosny sous Bois Cedex FRANCE Made in China Know your unit Compressor Main Unit x 1 Rear View Nebulizer Kit Holder Ventilation Slots Power Plug Ventilation Slots Air Filter Cover Air Tube Connector Power Switch Nebulizer Kit x 1 Mouthpiece x 1 d ALA Que
9. gt y Cm Inhalation Air Inlet 4 Nosepiece x 1 Adult Mask PVC x1 Child Mask PVC x 1 Nozzle A Medication Tank Air Tube Connector Air Tube PVC 200cm x 1 Carrying Bag x 1 Instruction Manual Spare Air Filters x 5 Warranty card Important safety instructions Read all the information in the instruction manual and any other literature included in the box before using the device h Indicates a potentially hazardous situation which if not avoided could result in A Warning serious inks Usage e For type dose and regime of medication follow the instructions of your doctor or respiratory therapist If you feel anything unusual during use stop using the device immediately and consult your doctor Do not use only water in the nebulizer for inhaling purposes Keep the device out of the reach of unsupervised infants and children The device may contain small pieces that can be swallowed Do not store the air tube while there is moisture or medication remaining inside Do not use or store the device where it may be exposed to noxious fumes or volatile substances Do not use the device where it may be exposed to flammable gas Do not cover the compressor with a blanket towel or any other type of cover during use Always dispose of any remaining medication after use and use fresh medication each time Do not use in anaesthetic or ventilator breathing circuits Do not block the ventilation slots Ne
10. ion Do not touch the compressor for other than necessary operation such as turning off the power while nebulizing To avoid the medication residue on the face be sure to wipe the face after removing the mask To avoid injury to the nose mucosa do not squeeze the nosepiece into the back of the nose Do not block the slit between the cap and the inhalation air inlet Make sure that the vaporiser head is correctly installed before use Do not use a damaged nebulizer kit mouthpiece or nosepiece Risk of electrical shock e Always unplug the device from the power outlet after use and before cleaning e Plug the device into the appropriate voltage outlet Do not overload power outlets or use extension cords e Do not misuse the power cord e Do not wind the power cord around the compressor Changes or modifications not approved by OMRON HEALTHCARE will void the user warranty Cleaning and disinfecting Observe the rules below when cleaning or disinfecting parts Failure to observe these rules may result in damage inefficient nebulization or infection For the instructions refer to Cleaning and disinfecting section e Do not use a microwave oven dish dryer or hair dryer to dry the device or the parts Do not use an autoclave EOG gas sterilizer or low temperature plasma sterilizer e When disinfecting parts by boiling make sure that the container does not boil dry Otherwise it may also result in fire General S
11. ld Mask PVC 5 pcs Spare Air Filters Carring Bag Instruction Manual Warranty Card Class Il equipment Type B applied part Read the instruction ci manual carefully Power on C 0197 Technical data for the OMRON NE C28P Compressor with the V V T Nebulizer Kit N 01 Particle Size Medication Tank Capacity Appropriate Medication Quantities Sound Nebulization Rate Aerosol Output Aerosol Output Rate MMAD Approx 3um MMAD Mass Median Aerodynamic Diameter 7ml maximum 2ml minimum 7ml maximum Noise level at 1 m distance 60dB Approx 0 5ml min by weight loss 0 4ml 2ml 1 NaF 0 09ml min 2ml 1 NaF Result of cascade impactor measurements for particle size Cumulative particle mass of sodium fluoride undersize ive Undersize Cumulati Particle Size Dp um Measured by OMRON HEALTHCARE Co Ltd Independently measured by Prof Dr Hiroshi Takano Department of Chemical Engineering and Materials Science Faculty of Science and Engineering Doshisha University Kyoto Japan according to EN 13544 1 2007 A1 2009 Notes e Subject to technical modification without prior notice This OMRON product is produced under the strict quality system of OMRON HEALTHCARE Co Ltd Japan The device may not work if the temperature and voltage conditions are different to those defined in the specifications e The device fulfils the provisions of the EC directive 93 4
12. lso not interfere with other devices In order to regulate the requirements for EMC Electro Magnetic Compatibility with the aim to prevent unsafe product situations the EN60601 1 2 2007 standard has been implemented This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices This medical device manufactured by OMRON HEALTHCARE conforms to this EN60601 1 2 2007 standard for both immunity and emissions Nevertheless special precautions need to be observed Do not use mobile cellular telephones and other devices which generate strong electrical or electromagnetic fields near the medical device This may result in incorrect operation of the unit and create a potentially unsafe situation Recommendation is to keep a minimum distance of 7 m Verify correct operation of the device in case the distance is shorter Further documentation in accordance with EN60601 1 2 2007 is available at OMRON HEALTHCARE EUROPE at the address mentioned in this instruction manual Documentation is also available at www omron healthcare com Correct Disposal of This Product Waste Electrical amp Electronic Equipment This marking shown on the product or its literature indicates that it should not be disposed of with other household wastes at the end of its working life To prevent possible harm to the environment or human health from uncontrolled waste dispo
13. o Cleaning and disinfecting section 1 2 Make sure that the power switch is in the off O position Plug the power plug into a power outlet Remove the cap and the inhalation top from the medication tank Add the correct amount of prescribed medication to the medication tank Make sure that the vaporiser head is securely attached to the inhalation top Put the inhalation top back inside the medication tank Attach the cap and mask mouthpiece or nosepiece to the nebulizer kit tightly S Note G It is not necessary to attach the cap when nebulizing with Adult mask If the amount of aerosol is too great attach the cap Attach the air tube Twist the air tube plug slightly and push it firmly into the air tube connector Hold the nebulizer kit as indicated on the right Follow the instructions of your doctor or respiratory therapist Right angle POS x yo A Caution Do not tilt the nebulizer kit at an angle of greater than 45 degrees in all directions Medication may flow into the mouth or it may result in not nebulizing effectively 10 Press the power switch to the on position As the compressor starts nebulization begins and aerosol is generated Inhale the medication 11 When treatment is complete turn the power off and unplug the compressor from the power outlet Cleaning and daily disinfecting Cleaning Clean the parts after each use to remove residual medi
14. sal please separate this product from other types of wastes and recycle it responsibly to promote the sustainable reuse of material resources Household users should contact either the retailer where they purchased this product or their local government office for details of where and how they can return this item for environmentally safe recycling Business users should contact their supplier and check the terms and conditions of the purchase contract This product should not be mixed with other commercial wastes for disposal Optional Medical Accessories within the scope of EC Medical Device Directive 93 42 EEC Name Model Order No eae ea NEB NSET3 81E 9515573 6 Adult Mask PVC NEB MSLP E 9956275 1 Child Mask PVC NEB MSMP E 9956276 0 Adult Mask SEBS NEB MSLS E 9956312 0 Child Mask SEBS Set NEB MSSS E 9956281 6 Mouthpiece NEB MP E 9956273 5 Nosepiece NEB NP E 9956274 3 Air Tube PVC 200cm NEB TP L20E 9520606 3 Air Tube Silicone 100cm NEB TSC L10E 9956269 7 Other Optional Replacement Parts Name Model Order No Air Filters x 5 NEB AFR 28E 9956271 9 How to use A Warning Clean and disinfect the nebulizer kit mask mouthpiece or nosepiece before using them when as follows the first time after purchase if the device has not been used for a long period of time if more than one person uses the same device For the instructions refer t
15. tane Amphoteric Surfactant Boiling an example of commercially available disinfectant 4 A Use a commercially available disinfectant Follow the instructions provided by the disinfectant manufacturer Note Never clean with benzene thinner or a flammable chemical B Parts may be boiled between 15 to 20 minutes After boiling carefully remove the parts shake off excess water and allow to air dry in a clean environment A Caution Handling the Vaporiser Head Always wash the vaporiser head after each use e Do not use a brush or pin to clean the vaporiser head e When disinfecting the parts by boiling be sure to boil them in plenty of water e Do not boil vaporiser head together with objects other than applicable nebulizer accessories Removing condensation from the air tube If there is moisture or liquid remaining in the air tube be sure to follow the procedure below to remove any moisture from within the air tube 1 Make sure that the air tube is connected to the air connector on the compressor 2 Remove the air tube from the nebulizer kit 3 Turn on the compressor and pump air through the air tube to expel the moisture Changing the air filter If the air filter has been used for more than 60 days replace it with a new one 1 Pull the air filter cover off the compressor 2 Change the air filter Remove the old air filter with a sharp object and insert th
16. ver place the device where the ventilation slots may be obstructed during operation Store the parts in a clean location for avoiding infection Risk of electrical shock e Never plug or unplug the device with wet hands The compressor and power cord are not waterproof Do not spill water or other liquids on these parts If liquid does spill on these parts immediately unplug the power cord and wipe off the liquid with gauze or other absorbent material Do not immerse the compressor in water or other liquid Do not use or store the device in humid locations Do not operate the device with a damaged power cord or plug Keep the power cord away from heated surfaces Cleaning and disinfecting Observe the rules below when cleaning or disinfecting parts Failure to observe these rules may result in damage inefficient nebulization or infection For the instructions refer to Cleaning and disinfecting section e Clean and disinfect the nebulizer kit mask mouthpiece or nosepiece before using them when as follows the first time after purchase if the device has not been used for a long period of time if more than one person uses the same device e Be sure to wash or wipe the parts after use and ensure that they are thoroughly disinfected and dried and stored in a clean location e Do not leave the cleaning solution in the parts A Caution Indicates a potentially hazardous situation which if not avoided may result in minor
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