Related Manuals for Omron M2
Summary of Contents for Omron M2
- Page 1 New Product Information Sheet Specifications subject to change © OMRON HEALTHCARE EUROPE B.V. Model (code): M2 (HEM-7143-E) Versions Remark Date version, without key 31/08/2021 market visual PM-2044-01-08/2021...
- Page 2 Accurate measurements in one touch Product Name M2 (HEM-7143-E) Product Description Automatic Upper Arm Blood Pressure Monitor Product Category Electronic Sphygmomanometers Features • Intellisense • Irregular heartbeat detection • Hypertension indicator • Body movement detection • Cuff wrap guide • 30 memories capacity •...
- Page 3 General description M2 Automatic Upper Arm Blood Pressure Monitor 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. Intended use This device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.
- Page 4 How to use the device? Please refer to the IM1 and IM2 for full details on the application of this product. Main steps: 1. Prepare for a measurement. 30 mins before it you shouldn’t drink alcohol, smoke, have a hot shower, consume hot beverages, eat or exercise.
- Page 5 Transportation and storage conditions • Keep your monitor in the storage case when not in use. • Do not store your monitor and other components: - If your monitor and other components are wet. - In locations exposed to extreme temperatures, humidity, direct sunlight, dust or corrosive vapors such as bleach.
- Page 6 DO NOT use this monitor in oxygen rich environments or near • flammable gas. Consult with your physician before using this monitor if you have • common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation; arterial sclerosis; poor perfusion; diabetes; pregnancy;...
- Page 7 • DO NOT use this monitor on an injured arm or an arm under medical treatment. • DO NOT apply the arm cuff on your arm while on an intravenous drip or blood transfusion. • DO NOT use this monitor in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, computerized tomography (CT) scanners.
- Page 8 • Consult with your physician before using this monitor if you have severe blood flow problems or blood disorders as cuff inflation can cause bruising. • DO NOT take measurements more often than necessary because bruising, due to blood flow interference, may occur. •...
- Page 9 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...
- Page 10 • Do not damage it. / Do not break it. / Do not tamper with it. • DO NOT pinch it. / Do not forcibly bend or pull it. / Do not twist it. • DO NOT use it if it is gathered in a bundle. •...
- Page 11 5 years Repair During the period of warranty OMRON will, without charge for labor 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 12 Technical data Product description Automatic Upper Arm Blood Pressure Monitor Product Category Electronic Sphygmomanometers Model (code) M2 (HEM-7143-E) Display LCD digital display Cuff Pressure range 0 to 299 mmHg Blood pressure SYS: 60 to 260 mmHg measurement range DIA: 40 to 215 mmHg Pulse measurement range 40 to 180 beats / min.
- Page 13 life) AC adapter: 5 years Operating conditions +10 to +40 °C / 15 to 90% RH (non- condensing)/ 800 to 1060 hPA Storage / Transport -20 to +60 °C / 10 to 90% RH (non- conditions condensing) Cuff circumference 17 to 42 cm (included arm cuff: (22 to 32 applicable to the monitor Memory Store up to 30 readings...
- Page 14 CS2 Small Cuff HEM-CS24 Materials used in main device Parts name Material Housing HIPS WT (High Impact Polystyrene White) Battery Cover HIPS WT (High Impact Polystyrene White) Front Panel T0.188 PET Cuff Cotton, Polyester Package Coated board E/F Instruction Manual Wood free paper Materials for (optional) accessories Parts name...
- Page 15 4015672113060 UDI-DI/EAN code Minimum order quantity HS/CN custom commodity code 9018901000 Title pages of Instruction Manual PM-2044-01-08/2021...
- Page 16 PM-2044-01-08/2021...
- Page 17 Unfolded package design of main device and accessories Main device: PM-2044-01-08/2021...
- Page 18 Included Accessory PM-2044-01-08/2021...
- Page 19 Optional Accesories PM-2044-01-08/2021...
- Page 20 PM-2044-01-08/2021...
- Page 21 List of Classification, Applicable Directives/Regulations and Harmonized EN Standards The device is classified according to Medical Device Regulation (EU)2017/745 ANNEX VIII, Rule 10 as Class IIa medical device. Regulation (EU)2017/745 (Medical Device Regulation) -EN 60601-l:2006+Al:2013 -EN 60601-1-2:2015 -EN 60601-l-6:2010+Al:2015 -EN 60601-1-11: 2015 -EN 1060-l:1995+A2:2009 -EN 1060-3: 1997+A2:2009 -EN IEC 80601-2-30:2019...
- Page 22 617-0002 Japan SRN: JP-MF-000007213 PRODUCTION FACILITY Omron Healthcare Brasil Indústria e Comércio de Produtos Médicos Ltda Av. Ain Ata (Lot. M II. P I Logístico), nº 370 – Lote 12 – Quadra B – Jardim Ermida I 13212-213 – Jundiai – SP – Brazil EU-REPRESENTATIVE OMRON HEALTHCARE EUROPE B.V.