Omron M4 Intelli IT New Product Information Sheet

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M4 Intelli IT (HEM-7155T-EBK)

X4 Smart (HEM-7155T-ESL)

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New Product Information Sheet

Specifications subject to change

Model (code):

Remark

Logistics and Standards info

not complete;

Full NPIS

Correction of EAN code for

X4 Smart

Correction of typo (not M3 but

M4 Intelli IT)

Date

31.07.2019

26.09.2019

02.10.2019

07.10.2019

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Summary of Contents for Omron M4 Intelli IT

Page 1 New Product Information Sheet Specifications subject to change © OMRON HEALTHCARE EUROPE B.V. Model (code): M4 Intelli IT (HEM-7155T-EBK) X4 Smart (HEM-7155T-ESL) Versions Remark Date Logistics and Standards info 31.07.2019 not complete; Full NPIS 26.09.2019 Correction of EAN code for 02.10.2019...
Page 2 PM-1824-04-10/2019...
Page 3 PM-1824-04-10/2019...
Page 4 Intelli Wrap Cuff The easy way to get accurate results Product Name: M4 Intelli IT (HEM-7155T-EBK), X4 Smart (HEM-7155T-ESL) Product Description: Automatic upper arm blood pressure monitor Product Category: Electronic Sphygmomanometers Features Packaging content - Intelli Wrap Cuff (HEM-FL31) - Monitor...
Page 5 Technical data Product description Automatic Upper Arm Blood Pressure Monitor Product Category Electronic Sphygmomanometers Model (code) M4 Intelli IT (HEM-7155T-EBK) X4 Smart (HEM-7155T-ESL) Measurement method Oscillometric method Transmission method Bluetooth® Low Energy Display LCD digital display Wireless communication Frequency range: 2.4 GHz (2400 - 2483.5 MHz) / Modulation: GFSK Effective radiated power: <...
Page 6 AC adapter (HHP-CM01), AC Adapter UK version (HHP- BFH01. General description Thank you for purchasing the OMRON Automatic Upper Arm Blood Pressure Monitor. This 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.
Page 7 This device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. Features (Particularities) The M4 Intelli IT Automatic Upper Arm Blood Pressure Monitor is a clinically validated device. Key features:  Irregular Heartbeat Detection ...
Page 8 8. Check the readings. Consult Section 9 of IM2 on the symbols that may appear. 9. After selecting your used ID, you can use the memory functions (readings stored, average of the latest 2-3 readings, clear memory). Please, review Instruction Manual 1 and 2 for the full details on the application of this product.
Page 9 Title page of Instruction Manuals IM1: IM2: PM-1824-04-10/2019...
Page 10 Unfolded package design of main device and accessories Main device: PM-1824-04-10/2019...
Page 11 Accessories: Arm Cuff (HEM-FL31) AC Adapter (HHP-CM01) PM-1824-04-10/2019...
Page 12 AC Adapter (HHP-BFH01) 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...
Page 13: Maintenance
EN ISO 13485:2016 EN ISO 14971:2012 EN ISO 15223-1:2016 EN ISO 81060-2:2014 Operation and care Cleaning of the device The device should be cleaned with a soft dry cloth, or a soft cloth moistened with neutral soap to clean on the monitor and the arm cuff. •...
Page 14 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! • DO NOT use this monitor on infants, toddlers, children or persons who cannot express themselves.
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 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.
Page 17 • Inflating to a higher pressure than necessary may result in bruising of the arm here the cuff is applied. NOTE: refer to “If your systolic pressure is more than 210 mmHg” in section 11 of instruction manual 2 for additional information. •...
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 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.

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X4 smart Hem-7155t-ebk Hem-7155t-esl