Automatic upper arm digital blood pressure monitor
Certifications
CE Marked medical device, typically classified as Class IIa under EU Medical Device Regulation (EU) 2017/745 / previously Medical Device Directive 93/42/EEC for non Invasive blood pressure monitors.
Manufactured under a certified quality management system for medical devices (such as ISO 13485), as stated in Omron Healthcare’s regulatory documentation.
Conforms to EN 60601 1 (basic safety and essential performance of medical electrical equipment) and EN 60601 1 2:2015 (electromagnetic compatibility) as referenced in the instruction manual.
CE Marked medical device, typically classified as Class IIa under EU Medical Device Regulation (EU) 2017/745 / previously Medical Device Directive 93/42/EEC for non Invasive blood pressure monitors.
Manufactured under a certified quality management system for medical devices (such as ISO 13485), as stated in Omron Healthcare’s regulatory documentation.
Conforms to EN 60601 1 (basic safety and essential performance of medical electrical equipment) and EN 60601 1 2:2015 (electromagnetic compatibility) as referenced in the instruction manual.
Complies with applicable standards for non Invasive sphygmomanometers and Bluetooth Low Energy wireless communication in the 2.4 GHz band.
Description
The OMRON M7 Intelli IT is a clinically validated, automatic upper arm blood pressure monitor with Bluetooth connectivity that can indicate the possible presence of atrial fibrillation (AFib). Using OMRON’s Intelli Wrap cuff (arm circumference 22–42 cm) and Intellisense technology, it delivers accurate and comfortable measurements in almost any cuff position around the upper arm. The device supports two users with extensive memory, averages multiple consecutive readings for greater reliability, and connects to the OMRON connect app so users can track and share their blood pressure readings at home. It is recommended for adult home blood pressure monitoring and is part of OMRON’s range of CE-marked, Class IIa medical devices.
Bnefits
Clinically validated automatic upper arm blood pressure monitor designed for adult home use.
AFib indicator function that can signal the possibility of atrial fibrillation during measurement, helping to identify a common, often undetected arrhythmia associated with increased stroke risk.
Intelli Wrap cuff (22–42 cm) provides accurate readings in virtually any position around the upper arm, reducing errors from incorrect cuff placement.
Bluetooth-enabled and compatible with the OMRON connect app for automatic transfer, storage and review of blood pressure readings on a smartphone.
Can take three consecutive measurements at 30-second intervals and display the average, providing a more reliable estimate of a user’s blood pressure.
Dual-user memory (2 users × 100 readings) plus guest mode, enabling monitoring for two individuals while keeping their measurement histories separate.
Cuff Wrap Guide and body movement detection functions help users obtain correct measurements and avoid invalid readings.
Irregular heartbeat and high blood pressure indicators support easy interpretation of results and highlight when readings may be outside the normal range.
Large, easy-to-read display and compact design with included storage case make the device convenient for everyday home monitoring.
Backed by OMRON’s multi-year warranty (typically up to 5 years in many European markets) and reputation as a leading cardiologist-recommended brand for home blood pressure monitors in Europe.
Complies with applicable standards for non Invasive sphygmomanometers and Bluetooth Low Energy wireless communication in the 2.4 GHz band.
OMRON connect compatibility and associated data security and privacy standards for connected health devices in relevant jurisdictions.
OMRON connect compatibility and associated data security and privacy standards for connected health devices in relevant jurisdictions.
Automatic upper arm digital blood pressure monitor
Non-invasive measurement and monitoring of systolic blood pressure, diastolic blood pressure and pulse rate in adults via the upper arm.
Home blood pressure monitoring for people with diagnosed or suspected hypertension, under the guidance of a healthcare professional.
Screening for a possible presence of atrial fibrillation (AFib) in adults when using the AFib measurement mode, as part of broader cardiovascular risk assessment.
Monitoring blood pressure trends over time, including morning and evening readings, to support clinical decision-making and therapy adjustments.
Use in specific validated populations such as patients with type II diabetes and in pregnancy (including pre-eclampsia), in accordance with published validation data and local labelling.
Composition
Electronic oscillometric sphygmomanometer main unit (M7 Intelli IT, model code HEM-7361T-EBK) with digital LCD display.
Intelli Wrap upper arm cuff (HEM-FL31) suitable for arm circumference 22–42 cm, including bladder, outer cuff material and connecting tubing.
Built-in electric pump, pressure sensor and automatic pressure release valve enabling automatic inflation and deflation.
Four 1.5 V AA (LR6) alkaline batteries as standard power supply, with optional AC adapter (HHP-CM01 or HHP-BFH01, depending on market).
Integrated Bluetooth Low Energy module for wireless communication with compatible smartphones and the OMRON connect app.
Plastic housing, electronic circuit boards and other internal components designed for non-invasive, reusable home blood pressure measurement.
Formulation
Automatic upper arm electronic blood pressure monitor operating on the oscillometric measurement principle.
Measures systolic blood pressure, diastolic blood pressure and pulse rate, with AFib detection function in specific measurement mode.
Intellisense technology ensures automatic inflation to an optimal level and controlled deflation tailored to the user, improving measurement comfort and accuracy.
Typical accuracy (from the instruction manual): pressure ±3 mmHg; pulse ±5% of the displayed value under specified test conditions.
Wireless communication via Bluetooth Low Energy in the 2.4 GHz band for connection with the OMRON connect mobile app.
Device classification IP20 for the main unit, with optional AC adapter classified IP21 or IP22 depending on model, as per the technical specifications.
Packaging
Retail box containing: 1 × OMRON M7 Intelli IT blood pressure monitor (HEM-7361T-EBK) and 1 × Intelli Wrap upper arm cuff (22–42 cm).
Includes Instruction Manual 1 and Instruction Manual 2 (multilingual), setup/installation guide and, in many markets, a blood pressure record card.
Supplied with 4 × AA alkaline batteries for immediate use and a rigid or semi-rigid storage case for the monitor and cuff.
Outer packaging printed with product name, model code HEM-7361T-EBK, EAN code (e.g. 401567211172), technical specifications, regulatory symbols and CE marking.
Device and packaging include Bluetooth and other regulatory marks, as well as references to compatibility with the OMRON connect app.
Usage
Before first use, read Instruction Manual 1 and Instruction Manual 2 carefully and keep them accessible for future reference.
Insert the supplied AA batteries into the battery compartment, ensuring correct polarity, or connect an approved OMRON AC adapter if used.
Connect the Intelli Wrap cuff to the monitor and place the cuff on the bare upper arm, 1–2 cm above the elbow, with the cuff mark aligned over the brachial artery.
Wrap the cuff snugly but not too tight around the arm within the specified circumference range (22–42 cm), ensuring there is no clothing under the cuff.
Sit comfortably with your back supported, feet flat on the floor and the arm with the cuff resting at heart level; relax and remain still and silent for several minutes before measurement.
Press the Start/Stop button to begin a standard blood pressure measurement; for AFib screening, activate the dedicated AFib mode as described in the manual so that three consecutive measurements are taken and averaged.
Remain still and do not talk while the cuff inflates and deflates automatically. The device will display systolic pressure, diastolic pressure, pulse rate and any relevant icons (e.g. AFib indicator, irregular heartbeat, cuff wrap guide, body movement).
Review the measurement on the display; use the memory functions to store and recall readings for each user profile. Pair the monitor with a compatible smartphone and use the OMRON connect app to sync, store, and review readings if desired.
Take measurements at times and frequencies recommended by your healthcare professional (often morning and evening); avoid repeated measurements in quick succession on the same arm unless specifically required.
After use, switch off the device, remove the cuff, and store the monitor and cuff in the provided case in a cool, dry place. Do not share a user memory profile between different individuals; use separate user profiles or guest mode.
Contraindications
Not intended for use in infants or children, or in individuals whose arm circumference is outside the specified cuff range (22–42 cm), unless explicitly authorised by the manufacturer and a healthcare professional.
Do not place the cuff on an arm being used for intravenous infusion, blood transfusion, or with an arteriovenous (A–V) shunt (e.g. dialysis fistula) unless specifically instructed by a clinician.
Use with particular caution, and under medical supervision, in patients with severe arrhythmias, advanced arterial sclerosis, poor peripheral circulation, diabetes complications, or in pregnancy with hypertension, as these conditions may affect accuracy.
Do not use the device in environments with strong electromagnetic interference (e.g. HF surgical equipment, MRI, CT, or oxygen-rich environments) as this may cause malfunction or inaccurate readings.
Home measurements must not be used as the sole basis for initiating or changing prescription medication; changes to treatment should only be made in consultation with a healthcare professional.
Adverse Effects
Temporary discomfort, tightness, tingling or numbness in the arm or hand due to cuff inflation pressure, particularly with repeated measurements.
Possible transient skin irritation or redness at the cuff application site, especially in individuals with sensitive skin or with prolonged, frequent use.
Rare bruising at the cuff site in patients with fragile skin, bleeding disorders or on anticoagulant therapy.
Potential for misleading or inaccurate readings if instructions are not followed (e.g. talking, moving, incorrect cuff placement), which could lead to inappropriate self-assessment of blood pressure status.
In individuals with certain arrhythmias or severe circulatory problems, the device may have reduced accuracy, which could delay appropriate medical evaluation if relied upon without professional guidance.
Storage Conditions
Store the monitor and cuff in a cool, dry place away from direct sunlight, extreme temperatures, dust, and moisture.
Typical operating conditions (from the instruction manual): temperature +10°C to +40°C, relative humidity 15–90% (non-condensing).
Typical storage and transport conditions: temperature −20°C to +60°C, relative humidity 10–90% (non-condensing).
Do not store the device or cuff when wet, do not expose them to strong vibrations or shocks, and do not place heavy objects on top of the monitor or cuff.
Remove the batteries if the monitor will not be used for an extended period to avoid battery leakage.
Duration
Not applicable; the device is intended for long-term, intermittent home blood pressure monitoring according to medical advice rather than a fixed treatment course.
Onset
Blood pressure and pulse measurements are typically obtained within approximately 30\u201360 seconds from the start of a measurement cycle.
