Omron M6 Comfort AFib Manual
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Summary of Contents for Omron M6 Comfort AFib
- Page 1 New Product Information Sheet Specifications subject to change © OMRON HEALTHCARE EUROPE B.V. Model (code): M6 Comfort AFib (HEM-7380-E) Versions Remark Date version: without key visual 29/04/2024 PM-2110-01-03/2024...
- Page 2 (Marketing material (key visual) will be ready by mid May) PM-2110-01-03/2024...
- Page 3 M6 Comfort AFib Screen for AFib with every blood pressure check at home Product Name: M6 Comfort AFib (HEM-7380-E) Product Description: Automatic blood pressure monitor Product Category: Electric Sphygmomanometers Features Packaging content - Intelli wrap cuff - Monitor - Possible Atrial Fibrillation indicator...
- Page 4 Technical data Measurement Oscillometric method method Display LCD digital display Cuff Pressure range 0 to 299 mmHg Pulse measurement 40 to 180 beats / min. range Blood pressure SYS: 60 to 260 mmHG, DIA: 40 to 215 mmHG measurement range Accuracy Pressure +/- 3mmHg, Pulse +/- 5% of display reading...
- Page 5 +10 to +40 °C / 15 to 90 % RH (non‑condensing) Operating conditions / 800 to 1060 hPa AC adaptor: HHP-CM01, HHP-BFH01, Optional accessories Cuff: HEM-FL31 General description This device uses the oscillometric method of blood pressure measurement. This means this monitor detects your blood movement through your brachial artery and converts the movements into a digital reading.
- Page 6 Features (Particularities) The M6 Comfort AFib Automatic Upper Arm Blood Pressure Monitor is a clinically validated device. Description of operating principle The device operates on the oscillometric principle. It detects blood movement through the brachial artery and converts the movements into a digital reading.
- Page 7 Materials used in main device Parts Name Material Front Housing ABS (Acrylonitrile-Butadiene-Styrene Compound Resin) Ground Housing ABS (Acrylonitrile-Butadiene-Styrene Compound Resin) Front Panel PMMA (Poly-Methyl-Meth-Acrylate Compound Resin) Button ABS (Acrylonitrile-Butadiene-Styrene Compound Resin) Battery Cover HIPS (High Impact Polystyrene) Rubber Foot PUR (Polyurethane Rubber) Air Connector Cap POM (Poly-Oxy-Methylene Compound Resin) Storage Case...
- Page 8 Title page of Instruction Manual IM1: IM2: PM-2110-01-03/2024...
- Page 9 Unfolded package design of main device and accessories Main device: PM-2110-01-03/2024...
- Page 10 Accessories: Included Accessory/Optional Accessories Arm Cuff (HEM-FL31) PM-2110-01-03/2024...
- Page 11 Optional Accessories AC Adapter (HHP-CM01) AC Adapter (HHP-BFH01) PM-2110-01-03/2024...
- Page 12 List of Harmonized EN Standards The device is classified as a medical device, Class IIa (MDR Annex VIII Rule Applicable Directives: - Medical Device Regulation (EU) 2017/745 EN 60601-I:2006 +A1:2013 +A2:2021 EN ISO 10993-1:2020 EN 60601-1-2:2015 +A1:2021 EN ISO 10993-5:2009 EN 60601-1-6:2010 +A1:2015 +A2:2021 EN ISO 10993-10:2013 EN 60601-1-11:2015 +A1:2021...
- Page 13 Warnings Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. ・ DO NOT adjust medication (including altering your use of any drug or treatment) based on readings from this blood pressure monitor. Take medication as prescribed by your physician.
- Page 14 addition to patient motion, trembling, or shivering may affect the measurement reading. ・ To help avoid strangulation, keep the air tube and AC adapter cable away from infants, toddlers and children. ・ This product contains small parts that may cause a choking hazard if swallowed by infants, toddlers and children.
- Page 15 ・ DO NOT use this monitor for any purpose other than measuring blood pressure and/or detecting a possibility of AFib. ・ During measurement, make sure that no mobile device or any other electrical device that emits electromagnetic fields is within 30 cm of this monitor.
- Page 16 For additional information on operating and storage / transport temperature, refer to section 6. ・ DO NOT use this monitor after the durable period has ended. Refer to section 6. ・ DO NOT crease the arm cuff or the air tube excessively. ・...
- Page 17 ・ Remove the batteries if this monitor will not be used for a long period of time. ・ If battery fluid should get in your eyes, immediately rinse with plenty of clean water. Consult with your physician immediately. ・ If battery fluid should get on your skin, wash your skin immediately with plenty of clean, lukewarm water.
- Page 18 Warranty: 5 years Lifetime: 5 years Repair During the period of warranty OMRON will, without charge for labour or parts, repair or replace the defect product or any defective parts. Servicing Should warranty service be required please apply to the dealer whom the product was purchased from or an authorised OMRON distributor.
- Page 19 OMRON HEALTHCARE Co., Ltd 53, Kunotsubo, Terado-cho, Muko, KYOTO, 617-0002 Japan PRODUCTION FACILITY OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. No.28 VSIP II, Street 2, Vietnam-Singapore Industrial Park II, Binh Duong Industry-Services-Urban Complex, Hoa Phu Ward, Thu Dau Mot City, Binh Duong Province, Vietnam EU-REPRESENTATIVE OMRON HEALTHCARE EUROPE B.V.
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