CE marked medical device for non Invasive blood pressure measurement in the European market.
Clinically validated according to recognised international or European hypertension protocols for accuracy.
Conforms to EN1060 and related standards for non Invasive sphygmomanometers (as per instruction manual).
Conforms to EN 60601 1 2:2015 Electromagnetic Compatibility (EMC) standard for medical electrical equipment.
CE marked medical device for non Invasive blood pressure measurement in the European market.
Clinically validated according to recognised international or European hypertension protocols for accuracy.
Conforms to EN1060 and related standards for non Invasive sphygmomanometers (as per instruction manual).
Conforms to EN 60601 1 2:2015 Electromagnetic Compatibility (EMC) standard for medical electrical equipment.
Manufactured under OMRON Healthcare quality management systems in line with applicable medical device regulations.
Description
The OMRON M3 Comfort (model HEM-7154-E) is a clinically validated, fully automatic upper arm blood pressure monitor designed for fast, easy and accurate home measurements. It uses OMRON Intellisense technology and is supplied with the Easy Cuff (22–42 cm), which fits most adult arm sizes and helps ensure correct cuff placement. The large display shows systolic and diastolic blood pressure as well as pulse rate, and the device can detect irregular heartbeats and body movement during measurement. It includes an easy high blood pressure indicator and supports two separate users with memory for up to 60 readings each, plus a storage case and batteries for convenient everyday use.
Bnefits
Fully automatic, easy-to-use upper arm blood pressure monitor with one-button operation.
Clinically validated for accuracy and reliability in measuring blood pressure at home.
Comfortable Easy Cuff (22–42 cm) covers both normal and larger adult arm sizes.
Cuff Wrap Guide function helps confirm that the cuff is correctly applied around the arm.
Intellisense technology automatically inflates the cuff to the optimal level for each user, improving comfort and measurement reliability.
Detects irregular heartbeat and displays a symbol when it occurs during measurement.
Body Movement Detection warns the user if movement may have affected the reading.
Easy High Blood Pressure Indicator highlights readings that are above recommended levels.
Memory for 2 users with up to 60 measurements each, enabling tracking of trends over time.
Includes a storage case and batteries, making it ready to use out of the box.
Compact, lightweight design (approx. 0.31 kg) suitable for home use and easy storage.
Indications
Non-invasive measurement of systolic and diastolic blood pressure and pulse rate at the upper arm in adult patients.
Home monitoring of hypertension and blood pressure trends between medical appointments.
Monitoring the effectiveness of antihypertensive treatment as part of a clinician-directed care plan.
Screening and self-checking for high blood pressure in adults at cardiovascular risk when used according to medical advice.
Manufactured under OMRON Healthcare quality management systems in line with applicable medical device regulations.
Automatic Upper Arm Blood Pressure Monitor
Composition
Electronic main unit: automatic oscillometric upper arm blood pressure monitor with integrated air pump, pressure sensor, control electronics and LCD display.
Easy Cuff (22–42 cm): pre-formed upper arm cuff with internal inflatable bladder and outer fabric shell designed for comfortable, correct placement.
Air tube and connector between cuff and main unit.
Power supply: 4 x 1.5 V AA alkaline or equivalent batteries (included).
Optional accessories (not included in all packs): approved OMRON AC mains adapter; alternative cuff sizes where available.
Formulation
Non-invasive, oscillometric automatic upper arm blood pressure and pulse rate monitor with Intellisense-controlled inflation, automatic deflation and digital display of measured values, irregular heartbeat detection, body movement detection, and dual-user memory storage.
Packaging
Retail box containing: OMRON M3 blood pressure monitor (HEM-7154-E), Easy Cuff (22–42 cm), 4 AA batteries, user manual 1, user manual 2/quick guide, and storage case.
Distributor reference code (example from France-Health): 7211180.
Usage
Install the 4 AA batteries in the battery compartment, observing correct polarity, or connect the optional approved OMRON AC adapter if used.
Connect the Easy Cuff firmly to the cuff connector on the monitor.
Wrap the Easy Cuff around the bare upper arm (left arm recommended), 1–2 cm above the elbow, with the tube aligned with the centre of the inner arm; ensure the cuff marker aligns as indicated and the cuff is at heart level.
Sit comfortably with back supported, feet flat on the floor and legs uncrossed. Rest quietly for at least 5 minutes before taking a measurement and avoid caffeine, alcohol, smoking, exercise and large meals for 30 minutes beforehand.
Select the appropriate user (User 1 or User 2) if tracking readings for two different individuals, following the instructions in the manual.
Press the START/STOP button. The cuff will automatically inflate and then deflate while the device measures blood pressure and pulse.
Remain still, do not talk, and keep the cuffed arm relaxed and supported during the measurement.
When the measurement is complete, read the systolic and diastolic blood pressure and pulse rate on the display along with any high blood pressure indicator or irregular heartbeat symbol.
To review stored measurements, use the memory button to scroll through previous readings for each user.
After use, press START/STOP to turn off the monitor or allow it to switch off automatically. Store the device, cuff and accessories in the supplied storage case.
Use only OMRON-approved cuffs and accessories specified for the HEM-7154-E and follow all safety and maintenance recommendations in the official instruction manual.
Contraindications
Do not use on infants or young children; the device and cuff are intended for adults whose arm circumference fits within the 22–42 cm range.
Do not use on an arm with an intravenous infusion line, blood transfusion, arteriovenous shunt or other vascular access device.
Do not use on an arm with severe skin damage, open wounds, or where recent surgery has occurred at or near the cuff site.
Use with caution and under medical supervision in patients with significant arrhythmias (e.g., atrial fibrillation), arterial sclerosis, diabetes, pregnancy or renal disease, as such conditions may influence measurement accuracy.
Not intended for use in environments with strong electromagnetic interference, such as during MRI or CT examinations, or in oxygen-rich/flammable atmospheres.
Adverse Effects
Temporary discomfort or pressure in the upper arm during cuff inflation.
Occasional minor bruising, redness or skin irritation under the cuff, particularly with repeated measurements or in individuals with fragile skin or bleeding disorders.
If pain, numbness, tingling or discolouration of the arm or hand occurs during measurement, the cuff should be removed immediately and use discontinued until advice is sought from a healthcare professional.
Storage Conditions
Store the monitor, cuff and accessories in the supplied storage case in a clean, dry location.
Protect from moisture, dust, direct sunlight and strong vibrations.
Avoid extreme temperatures and humidity; keep within the operating and storage ranges specified in the instruction manual.
Do not bend or twist the cuff or air tube sharply when storing the device.
Remove the batteries if the monitor will not be used for an extended period to prevent battery leakage.
Keep out of reach of infants and young children.
Duration
Used intermittently for single blood pressure measurements or regular monitoring sessions as advised by a healthcare professional; there is no fixed treatment duration for device use.
Onset
Immediate \u2014 each measurement cycle typically completes within seconds, with results displayed as soon as cuff deflation finishes.
