OMRON HEALTHCARE Co., Ltd 53, Kunotsubo, Terado-cho, Muko, KYOTO, 617-0002 Japan PRODUCION FACILITY OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. No.28 VSIP II, Street2, 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.
Included accessories / optional accessories General description The RS2 is an automatic wrist blood pressure monitor, operating on the oscillometric principle. This blood pressure monitor is to be worn on your wrist. When the cuff inflates, this monitor senses the pressure pulsations of the artery underneath the cuff.
This device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. Features (Particularities) RS2 (HEM-6161-E) is an automatic wrist type blood pressure monitor that has the unique selling points as noted: •...
• In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood pressure. • This monitor is clinically investigated according to the requirements of ISO 81060-2:2013. OMRON HEALTHCARE EUROPE B.V. Scorpius 33 2132 LR Hoofddorp The Netherlands P.O. Box 2050 2130 GL Hoofddorp The Netherlands Phone: +31 (0)23 55 44 700 fax +31 (0)23 55 44 701 www.omron.healthcare.com...
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• IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This monitor is protected against solid foreign objects of 12.5 mm diameter and greater such as a finger, and against oblique falling water drops which may cause issues during a normal operation. •...
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Title page of Instruction Manual PM-1769-E-01-03/2018...
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Unfolded package design of main device and accessories Main device: Accessories: Packaging specifications from Explanation Diagram Approx. dimensions Package Amount Approx. weight W x D x H, mm Main Unit 84 x 21 x 62 mm Package 320g 109 x 94 x 115 mm Master Carton 3.64kg 492 x 236 x 144 mm...
List of Harmonized EN Standards The device is classified as a medical device, Class IIa (MDD Annex IX Rule 10) Applicable Medical Device Directive (93/42/EEC) standards: EN ISO 15223-1:2016 EN 1041:2008 EN 1060ꞏ1:1995+A2:2009 EN 1060ꞏ3:1997+A2:2009 EN 60601-1:2006+A1:2013 EN 60601-1-2:2015 EN 60601-1-6:2010+A1:2015 EN 60601-1-11:2015 EN 80601-2-30:2010+A1:2015 EN 62304:2006+A1:2015...
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• DO NOT adjust medication based on readings from this blood pressure monitor. Take medication as prescribed by your physician. ONLY a physician is qualified to diagnose and treat high blood pressure. • DO NOT use this monitor on an injured wrist or a wrist under medical treatment. •...
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• Ensure that this monitor has acclimated to room temperature before taking a measurement. Taking a measurement after an extreme temperature change could lead to an inaccurate reading. OMRON recommends waiting for approximately 2 hours for the monitor to warm up or cool down when the monitor is used in an environment within the temperature specified as operating conditions after it is stored either at the maximum or at the minimum storage temperature.
Do not disassemble or attempt to repair the device or components. Consult your OMRON retail outlet or distributor. Servicing It is generally recommended to have the device inspected every 2 years to ensure correct functioning and accuracy. Please consult your OMRON retail outlet or distributor. PM-1769-E-01-03/2018...
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