Omron M7 Intelli IT Manual
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- Instruction manual (46 pages)
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New Product Information Sheet
М7 Intelli IT (HEM-7361T-EBK)
X7 Smart (HEM-7361T-ESL)
Versions
1
Logistics and Harmonized
2
3
Specifications subject to change
© OMRON HEALTHCARE EUROPE B.V.
Model (code):
Remark
Standards info not
complete
Full NPIS
Corrected a typo with
model code
PM-1827-02-09/2019
Date
01.08.2019
26.09.2019
23.04.2020
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Summary of Contents for Omron M7 Intelli IT
- Page 1 New Product Information Sheet Specifications subject to change © OMRON HEALTHCARE EUROPE B.V. Model (code): М7 Intelli IT (HEM-7361T-EBK) X7 Smart (HEM-7361T-ESL) Versions Remark Date Logistics and Harmonized 01.08.2019 Standards info not complete Full NPIS 26.09.2019 Corrected a typo with 23.04.2020...
- Page 2 PM-1827-02-09/2019...
- Page 3 PM-1827-02-09/2019...
- Page 4 1015 g 223 mm 633 mm x 340 mm x Master Carton 11.2 kg 263 mm EAN code M7 Intelli IT: 401567211172 1, X7 Smart : 401567211214 8 Storage & transport Temperature: - 20 to +60°C Humidity: 10% to 90% PM-1827-02-09/2019...
- Page 5 Technical data Product description Automatic Upper Arm Blood Pressure Monitor Product Category Electronic Sphygmomanometers Model (code) M7 Intelli IT (HEM-7361T-EBK) X7 Smart (HEM-7361T-ESL) Measurement Oscillometric method method Display LCD digital display Cuff Pressure range 0 to 299 mmHg Pulse measurement...
- Page 6 alkaline batteries) The number of times may decrease when using Afib mode because one Afib indication consists of 3 regular measurements. Durable period Monitor: 5 years / Cuff: 5 years / Optional AC (Service life) adapter: 5 years Operating conditions +10 to +40 °C / 15 to 90% RH (non- condensing)/ 800 to 1060 hPA Storage / Transport...
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Page 7: Application Field
Afib can only be confirmed by an Electrocardiogram (ECG). If the Afib symbol appears, consult with your physician Packaging content The manufacturer produces M7 Intelli IT / X7 Smart with the applicable accessories included, necessary for the application of its intended purpose. - Page 8 This device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. Features (Particularities) The M7 Intelli IT Automatic Upper Arm Blood Pressure Monitor is a clinically validated device. Key features: Afib indicator function ...
- Page 9 6. Sit correctly and place your arm at your heart’s level. Remain still and don’t talk. 7. Select user ID (1 or 2). 8. Take the measurement by pressing the START/STOP button. In the Afib mode, your monitor automatically takes 3 consecutive readings at 30-second intervals and display the average.
- Page 10 Title page of Instruction Manuals IM1: IM2: PM-1827-02-09/2019...
- Page 11 Unfolded package design of main device and accessories Main device: PM-1827-02-09/2019...
- Page 12 Accessories: Arm Cuff (HEM-FL31) List of Harmonized EN Standards The device is classified as a medical device, Class IIa (MDD Article 9 Annex IX Rule 10) Applicable Directives: Medical Device Directive (MDD) 93/42/EEC EN 1041:2008+A1:2013 EN 1060-1:1995+A2:2009 EN 1060-3:1997+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...
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Page 13: Maintenance
EN ISO 10993-5:2009 EN ISO 10993-10:2013 EN ISO 13485:2016 EN ISO 14971:2012 EN ISO 15223-1:2016 EN ISO 81060-2:2014 Cleaning of the device • Do not use any abrasive or volatile cleaners. • Use a soft dry cloth or a soft cloth moistened with mild (neutral) detergent to clean your monitor and arm cuff, and then wipe them with a dry cloth. - Page 14 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 unit! •...
- Page 15 AC Adapter (optional accessory) Handling and Usage • DO NOT use the AC adapter if this monitor or the AC adapter cable is damaged. If this monitor or the cable is damaged, turn off the power and unplug the AC adapter immediately. •...
- Page 16 • 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...
- Page 17 • 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. • DO NOT fold or kink the air tube while taking a measurement. This may cause an injury by interrupting blood flow.
- Page 18 Please use the Blood Pressure Diary to keep records of several readings over a certain period of time. To download PDF files of the diary, visit www.omron-healthcare.com. Disposal 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.
- Page 19 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. Repair or replacement under the warranty does not give rise to any extension or renewal of the warranty period.
- Page 20 LEGAL MANUFACTURER 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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