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Summary of Contents for Omron X105 Advanced
- Page 1 New Product Information Sheet Specifications subject to change © OMRON HEALTHCARE EUROPE B.V. Model (code): X105 Advanced (NE-C105-EO) Versions Remark Date w/o key visual 08/03/2021 PM-2031-01-03/2021...
- Page 2 X105 Advanced Highly efficient Nebulizer for frequent use. Product Name (code): X105 Advanced (NE-C105-EO) Product Description: Compressor Nebulizer Product Category: Aerosoltherapy Equipment Features Packaging content - Provides efficient medication - Compressor deposition in the lungs to treat - Nebulizer Kit...
- Page 3 Technical data Product description: Compressor Nebulizer Product Category: Aerosoltherapy Equipment Model (code): X105 Advanced (NE-C105-EO) Rating: 230V ~50Hz Power Consumption: 140VA Operating Mode: Continuous use Operating conditions: +5°C to +40°C / 15% to 85%RH / 700 to 1060 Storage / Transport conditions: -20°C to +60°C / 5% to 95%RH / 500 to 1060 hPa...
- Page 4 General description OMRON is introducing the X105 Advanced, a new addition to its Compressor Nebulizer portfolio. This product was developed in conjunction with respiratory therapists for the successful treatment of respiratory disorders such as asthma, chronic bronchitis, allergies, etc. This is a medical device. Operate the device only as instructed by your doctor and/or respiratory therapist.
- Page 5 Intended User • Persons who suffer from respiratory disorders and require inhalation of medications. • Legally certified medical experts, such as doctor, nurse and therapist or healthcare personnel or patient under the guidance of qualified medical experts. Before using this device please refer to “Important Safety Instructions” section of the Instruction Manual.
- Page 6 Nebulizer Kit with Valve Technology The X105 Advanced nebulizer is equipped with a breath-enhanced valve system which allows the maximum amount of medication to be inhaled by the patient. It optimizes the flow of medication during inhalation and reduces medication loss during exhalation.
- Page 7 Exhalation phase: When exhaling through the mouthpiece, the inhalation valve (A) of the nebulizer closes, preventing aerosol to leave the nebulizer. The aerosol generated remains in the nebulizer and becomes available for the next inhalation phase. The exhaled air leaves the mouthpiece through the exhalation valve (D).
- Page 8 7e. Attach the child mask to the support adapter and connect it to the nebulizer kit. 8. Attach the air tube. 9. Hold the nebulizer kit straight. Do not tilt more than 30 degrees in all directions. Follow the instructions of your doctor or respiratory therapist. 10.
- Page 9 Materials used in main device Grade Colorant Colorant Part’s name Material grade ABS (acrylonitrile Housing and ESTADIENE butadiene White WT-001 air filter cover 1640 styrene) Geotess Air Filter White RAL 9010 (polypropylene) EPDM (Ethylene- Legs Propylene Diene 50 Shore A Grey RAL 7035 Monomer)
- Page 10 Materials for accessories Item/part’s name Material Grade Colorant Colorant grade Medication Tank and Support PP (polypropylene) HP500N Transparent additional Adapter for Child colorant Mask Inhalation Top of PP (polypropylene) HP500N White WT-001 the Neb kit PP (polypropylene) Mouthpiece HP500N White WT-001 with TPE (Thermoplastic...
- Page 11 Title page of Instruction Manual PM-2031-01-03/2021...
- Page 12 Unfolded package design of main device and accessories Main device: Accessories: Nasal Shower NEB6014 PM-2031-01-03/2021...
- Page 13 List of Harmonized EN Standards The device is classified as a medical device, class IIa. Applicable standards: EN 13544-1:2007+A1 :2009 EN ISO 15223-1:2016 EN 1041:2008+A1 :2013 UNI EN ISO10993-1:2010 EN 10993-5 :2009 EN 10993-10:2010 EN 60601-1:2006/A11 :2011/A1 :2013 EN 60601-1-2:2015 EN 60601-1-11:2015 EN 60601-1-6:2010+A1:2015 EN 62366-1:2015...
- Page 14 replace the Nebulizer Kit and Mouthpiece after some 100 to 120 treatments or after about 20 boiling cycles ● Cleaning the Compressor: Make sure that the power plug is unplugged from the power outlet. Wipe clean with a soft cloth moistened with water or mild, neutral detergent. ●...
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Page 15: Maintenance
Maintenance This device does not require any regular maintenance. Storage Storage and transportation: Temperature range: -20°C to +60°C Humidity range: 5% to 95%RH Atmospheric pressure: 500 - 1060hPa Warnings (Warning indicate a potentially hazardous situation which, if not avoided, could result in death or serious injury.) It is important that you read all the warnings and precautions included in this instruction manual because they are intended to keep you safe, prevent injury and avoid a situation that could result in damage to the... - Page 16 10. This product should not be used on patients, who are unconscious or are not breathing spontaneously. 11. After finishing the treatment remember to disconnect the air tube from the nebulizer kit and from the compressor. 12. In view of their length, the power cord and air tube could constitute a strangulation hazard.
- Page 17 Do not attempt to repair the device. Do not open and/or tamper with the device. During the period of warranty OMRON will, without charge for labour or parts, repair or replace the defect product or any defective parts. Repair or replacement under the warranty does not give rise to any extension or renewal of the warranty period.
- Page 18 LEGAL MANUFACTURER & PRODUCTION FACILITY 3A HEALTH CARE S.r.l. Via Marziale Cerutti, 90F/G 25017 Lonato del Garda (BS), Italy DISTRIBUTOR OMRON HEALTHCARE EUROPE B.V. Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS PM-2031-01-03/2021...
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