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New Product Information Sheet
Specifications subject to change
© OMRON HEALTHCARE EUROPE B.V.
Model (code):
M3 Comfort (HEM-7155-E(C))
Versions
Remark
Date
1
Complete NPIS
17.11.2021

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July 3, 2025

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Summary of Contents for Omron HEM-7155-E(C)

  • Page 1 New Product Information Sheet Specifications subject to change © OMRON HEALTHCARE EUROPE B.V. Model (code): M3 Comfort (HEM-7155-E(C)) Versions Remark Date Complete NPIS 17.11.2021...
  • Page 2 PM-2078-01-10/2021...
  • Page 3 Intelli Wrap Cuff The easy way to get accurate results Product Name: M3 Comfort (HEM-7155-E(C)) Product Description: Automatic upper arm blood pressure monitor Product Category: Electric Sphygmomanometers Features Packaging content - Intelli Wrap Cuff (HEM-FL31) - Monitor - Irregular Heartbeat Detection - Arm Cuff (HEM-FL31-E) - 2 Users, 60 memories &...
  • Page 4 Technical data Product description Automatic Upper Arm Blood Pressure Monitor Product Category Electronic Sphygmomanometers Model (code) M3 Comfort (HEM-7155-E(C)) Measurement method Oscillometric method Display LCD digital display Cuff Pressure range 0 to 299 mmHg Pulse measurement 40 - 180 beats/min range Blood pressure SYS 60 to 260 mmHg, DIA: 40 to 215 mmHG.
  • Page 5 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 6 pulse rate in adult patient population. Features (Particularities) The M3 Comfort Automatic Upper Arm Blood Pressure Monitor is a clinically validated device. Key features: • Irregular Heartbeat Detection • 2 users x 60 memories, + guest mode • Cuff Wrap Guide Description of operating principle The device operates on the oscillometric principle.
  • Page 7 Housing ABS (acrylonitrile butadiene styrene) Battery Cover ABS (acrylonitrile butadiene styrene) Front Panel ABS (acrylonitrile butadiene styrene) Button ABS (acrylonitrile butadiene styrene) Package Coated board Instruction Manual Paper Materials for accessories Parts name Material Cloth, fabric Nylon, PVC (Polyvinyl Chloride) Air Tube PVC (Polyvinyl Chloride) Cuff...
  • Page 8 IM2: Unfolded package design of main device and accessories Main device: PM-2078-01-10/2021...
  • Page 9 Accessories: Arm Cuff (HEM-FL31) AC Adapter (HHP-CM01) PM-2078-01-10/2021...
  • Page 10 AC Adapter (HHP-BFH01) List of Harmonized EN Standards The device is classified as a medical device, Class IIa (MDR Annex VIII Rule 10) Applicable Directives: Medical Device Regulation (EU) 2017/745 EN 1041:2008+A1:2013 EN 1060-1:1995+A2:2009 EN 1060-3:1997+A2=2009 EN 60601-1:2006+A1:2013+A12:2014 EN 60601-1-2:2015 EN 60601-1-6:2010+A1:2015 EN 60601-1-11:2015 EN 62304:2006+A1:2015...
  • Page 11: Maintenance

    EN ISO 10993-5:2009 EN ISO 10993-10:2013 EN ISO 13485:2016 EN ISO 14971:2019 EN ISO 15223-1:2016 EN ISO 81060-2:2014 RoHS Directive 2011/65/EU, (EU)2015/863 and (EU)2017/2102 EN IEC 63000:2018 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 12 • In locations exposed to vibrations or shocks. 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 13 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 14 • 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 15 • 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 16 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 17 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.

This manual is also suitable for:

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