OMRON M4 Connect AFib (HEM-7196T1-FLE)

1. Introduction

Thank you for purchasing the OMRON automatic upper arm blood pressure monitor. This upper arm monitor uses the oscillometric method of blood pressure measurement. This means that this monitor detects the movement of blood in the brachial artery and converts the movements into a digital result.

1.1 Safety Instructions

This user manual provides important information about the OMRON automatic upper arm blood pressure monitor. To ensure safe and correct use of this monitor, READ all instructions and UNDERSTAND them. If you do not understand these instructions or have any questions, contact your retailer or OMRON product distributor before attempting to use this monitor. For more information about your blood pressure, consult your doctor.

1.2 Intended Use

This device is a digital monitor intended for measuring blood pressure and pulse rate in adult patients. The device can detect an irregular pulse, which may signal atrial fibrillation (AFib). Please note that this device is not intended for diagnosing atrial fibrillation (AFib).

*Note: Atrial fibrillation can only be diagnosed by a doctor using an electrocardiogram (ECG). If the atrial fibrillation symbol appears, consult your doctor.

Intended Patients

Adult patients

Intended Users

Adult patients (may include self-users) who understand this user manual.

Clinical Benefit

A patient's blood pressure can be measured non-invasively and easily from the comfort of home. The possibility of atrial fibrillation is detected from the pulse wave obtained through blood pressure measurement and communicated to the user.

Method of Use

This monitor is intended for multiple use by multiple patients.

Limitation

The patient's arm circumference must be within the range of 22 – 42 cm.

Indication

This device is used by healthy individuals, patients with elevated blood pressure, and health-conscious individuals in a normal home environment for the following purposes:

• Measuring blood pressure and pulse
• Assessing the possibility of atrial fibrillation

1.3 Receipt and Check

Remove the monitor and other components from the packaging and check for damage. If the monitor or any component is damaged, DO NOT USE IT and contact your OMRON retailer or distributor.

2. Important Safety Information

Read the Important Safety Information in this user manual before using this monitor. For your safety, follow the instructions below precisely. Keep the manual for future reference. For more information about your blood pressure, consult your doctor.

2.1 Contraindications

• DO NOT use the monitor on an injured or treated arm.
• DO NOT apply the arm cuff to an arm with an IV infusion or during blood transfusion.
• DO NOT use this monitor to measure the blood pressure of infants, toddlers, children, or persons who cannot express themselves.

2.2 Side Effects

• Measuring more frequently than necessary may lead to bruising due to interference with blood flow.
• Inflating to a higher pressure than necessary may cause bruising of the arm at the cuff application site. NOTE: For more information, see 'If your systolic pressure is higher than 210 mmHg' at the end of User Manual 2.
• If skin irritation or discomfort occurs, stop using the monitor and consult your doctor.

2.3 Warning

▲ Indicates potentially hazardous situations that, if not avoided, could result in minor or moderate injury to the user or patient, or damage to the device or property.

• DO NOT adjust treatment (including changing medication or therapy) based on the measurement results from this blood pressure monitor. Take medications as prescribed by your doctor. ONLY a doctor is qualified to diagnose and treat high blood pressure and heart-related conditions.
• NEVER self-diagnose or self-treat based on measurement results. ALWAYS consult a doctor.
• The atrial fibrillation screening function assesses ONLY the possibility of atrial fibrillation. The function DOES NOT detect other potentially life-threatening arrhythmias or conditions, such as other heart arrhythmias or heart attack.
• If you experience symptoms or have concerns, consult your doctor.
• DO NOT DELAY/DISCONTINUE regular check-ups or doctor visits based on results from this monitor.
• The atrial fibrillation screening function is not intended for users who have already been diagnosed with atrial fibrillation.

2.4 Safety Precautions

• This monitor may not detect atrial fibrillation in individuals with pacemakers or defibrillators. Therefore, individuals with pacemakers or defibrillators should not use this monitor to detect the possibility of atrial fibrillation.
• DO NOT use the monitor in areas with high-frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, or computed tomography (CT) scanners. This could cause monitor malfunction and/or incorrect measurement.
• DO NOT use the monitor in oxygen-rich environments or near flammable gases.
• Consult your doctor before using the device if you have common arrhythmias, such as premature atrial or ventricular contractions, or atrial fibrillation, arteriosclerosis, poor perfusion, diabetes, pregnancy, pre-eclampsia, or kidney disease. NOTE that any of these conditions, movement, trembling, or shivering by the patient may affect the measurement result.
• To prevent strangulation, keep the air tubing and AC adapter cable out of the reach of infants, toddlers, and children.
• This product contains small parts that could cause choking if swallowed by an infant, toddler, or child.

Data Transmission

• This product continuously emits radio frequency (RF) waves in the 2.4 GHz band. DO NOT use this product in places where RF is prohibited, such as on an aircraft or in hospitals. In locations where RF devices are prohibited, disable the Bluetooth® function on the monitor or remove the batteries and unplug the AC adapter.

AC Adapter (Optional Accessory) Handling and Use

• If the monitor or AC adapter cable is damaged, DO NOT use the AC adapter. If the monitor or cable is damaged, immediately turn off the power and unplug the AC adapter.
• Plug the AC adapter cord into an outlet with the specified voltage. DO NOT use in an outlet with an extension cord.
• NEVER plug or unplug the AC adapter from the power outlet with wet hands.
• NEVER disassemble or attempt to repair the AC adapter.

Battery Handling and Use

• Keep batteries out of the reach of infants, toddlers, and children.

General Notices

• To stop measurement, press the [START/STOP] button during measurement.
• When measuring on the right arm, the air tubing should be on the inside of the elbow. Ensure your arm is not resting on the air tubing.
• Blood pressure may differ between arms. Results may vary. Always measure on the same arm. If readings differ significantly between arms, ask your doctor which arm to use for measurement.
• Please note that OMRON will not be liable for loss of data and/or information in the app.
• The 'OMRON connect' app is the only app recommended for use with the monitor to ensure correct data transfer.
• When using the optional AC adapter, do not place the monitor where it is difficult to connect and disconnect the AC adapter.
• It is recommended to keep batteries in the monitor at all times, even if you choose to use the optional AC adapter. If only the AC adapter is used without batteries in the monitor, the date and time may need to be reset each time the AC adapter is disconnected and reconnected. Data will not be erased.

Battery Disposal

• Dispose of used batteries in accordance with local regulations.
• Supplied batteries may have a shorter lifespan than new batteries.
• Replacing batteries will not erase previous measurement results.

3. Operation Overview

The device is designed for measuring blood pressure and pulse rate. It also features AFib detection.

3.1 Preparing for Measurement

• Relax and rest for at least 5 minutes before measurement. Avoid bathing, drinking alcohol or caffeinated beverages, eating, smoking, or strenuous physical activity for at least 30 minutes prior.
• Ensure the monitor is acclimated to room temperature.

3.2 Taking a Measurement

1. Select your User ID (1 or 2).
2. Press the [START/STOP] button.
3. The cuff will inflate, and measurement will begin.
4. The display will show readings for SYS (Systolic), DIA (Diastolic), and Pulse.
5. The reading is saved automatically.

3.3 AFib Detection

The IntelliSense AFib technology can detect the possibility of atrial fibrillation even with a single measurement. If an irregular pulse is detected, the AFib symbol [AFib symbol] will appear on the display. This is a screening function and not a diagnosis. If the AFib symbol appears, consult your doctor.

3.4 Data Transfer

Measurement results can be transferred to a smart device via Bluetooth using the OMRON connect app. Ensure Bluetooth is enabled on your device and follow the app's instructions for pairing and data transfer.

3.5 Three-time Blood Pressure Mode

This mode automatically takes 3 consecutive readings at 30-second intervals and displays the average. To use this mode, refer to the device's detailed instructions.

3.6 Guest Mode

Allows a single measurement for another user without storing readings in memory.

4. Error Messages and Troubleshooting

If an error occurs, check the following:

Common Error Codes:

• E1: No cuff inflation or cuff does not inflate. Check cuff application, air plug connection, or for leaks.
• E2: Measurement cannot be completed. Ensure stillness during measurement; if persistent, manual inflation may be needed.
• E3/E4: Cuff over-inflated. Remain still during measurement.
• E5: Pulse rate not detected correctly. Remain still; consult doctor if irregular rhythm persists.
• Err: Monitor malfunction or connection issue. Restart the monitor or check app connection.

Other Issues:

• Irregular Rhythm Symbol: Indicates a potential irregular heartbeat. Consult your doctor.
• Bluetooth Symbol: Indicates pairing or connection status.
• Battery Indicator: Low battery requires replacement. Ensure correct polarity.
• No Display: Check batteries.
• High/Low Readings: Ensure correct cuff placement, stillness, and refer to manual for factors affecting readings.
• Other Problems: Refer to the OMRON connect app's help section or contact OMRON customer support.

5. Maintenance and Warranty

5.1 Maintenance

Keep the monitor clean and dry. Do not use abrasive cleaners. Clean the exterior with a soft, damp cloth. Do not immerse the monitor or cuff in water.

5.2 Storage

Store the monitor and accessories in their original packaging in a clean, safe, and dry place, away from extreme temperatures and direct sunlight.

5.3 Limited Warranty

OMRON provides a 5-year warranty from the date of purchase for this product. The warranty covers defects in workmanship and materials. It does not cover damage from misuse, accidents, or unauthorized repairs. Refer to the full warranty terms provided with the product.

6. Specifications

• Model: M4 Connect AFib (HEM-7196T1-FLE)
• Type: Automatic Upper Arm Blood Pressure Monitor
• Display: Digital LCD
• Measurement Range: Blood Pressure: 0-299 mmHg (SYS: 60-260, DIA: 40-215); Pulse Rate: 40-180 bpm
• Accuracy: Pressure: ±3 mmHg; Pulse: ±5% of reading
• Measurement Method: Oscillometric
• Connectivity: Bluetooth® Low Energy (2.4 GHz)
• Power: 4x AA Batteries or Optional AC Adapter
• Battery Life: Approx. 900 measurements
• Lifespan: Monitor: 5 years or 30,000 uses; Cuff: 5 years or 10,000 uses
• Operating Conditions: +10°C to +40°C, 15-90% RH
• Storage Conditions: -20°C to +60°C, 10-90% RH
• Arm Circumference: 22-42 cm
• Memory: Stores up to 60 readings per user
• Protection: Class II equipment, IP21 (Monitor)

7. Symbols Description

Key symbols found on the device and packaging:

• [CE Mark]: Conforms to European health, safety, and environmental protection standards.
• [UKCA Mark]: Conforms to UK conformity assessment requirements.
• [IP21]: Protection against solid objects >12.5mm and vertically falling water drops.
• [Bluetooth Symbol]: Indicates Bluetooth connectivity.
• [AFib Symbol]: Indicates potential detection of atrial fibrillation.
• [Medical Device Symbol]: Indicates the product is a medical device.
• [Type BF Applied Part Symbol]: Indicates a type BF applied part for electrical shock protection.
• [Serial Number]: Unique identifier for the device.
• [LOT Number]: Batch or lot number for traceability.
• [Recycle Symbol]: Indicates the product should be recycled.
• [Consult Manual Symbol]: Indicates the user should consult the instruction manual.
• [Latex Free Symbol]: Indicates the product does not contain natural rubber latex.

8. Legal and Compliance Information

8.1 Electromagnetic Compatibility (EMC)

This device complies with EN 60601-1-2:2015+A1:2021 for electromagnetic compatibility. Further documentation is available at: healthcare.omron.com/electro-magnetic-compatibility

8.2 Manufacturer and Declarations

OMRON HEALTHCARE Co., Ltd. declares that this device complies with Directive 2014/53/EU. The full EU declaration of conformity is available at: www.omron-healthcare.com. The AFib algorithm was developed using datasets from PhysioNet.

8.3 Trademarks

Bluetooth® word mark and logos are registered trademarks of Bluetooth SIG, Inc. Apple and the Apple logo are trademarks of Apple Inc. App Store is a service mark of Apple Inc. Google Play and the Google Play logo are trademarks of Google LLC. All other trademarks and trade names are the property of their respective owners.

8.4 Disposal

This product is marked with the WEEE symbol, indicating it should not be disposed of with household waste. Please recycle it responsibly.

9. Additional Information

What is Blood Pressure?

Blood pressure is the force of circulating blood against the walls of blood vessels. It changes throughout the cardiac cycle. Systolic blood pressure is the highest pressure, and diastolic blood pressure is the lowest. Both are important for assessing cardiovascular health.

What is Arrhythmia?

Arrhythmia, or irregular heartbeat, is an abnormal heart rhythm caused by errors in the heart's electrical impulses. It can manifest as skipped beats, rapid heart rate (tachycardia), slow heart rate (bradycardia), or an irregular rhythm.

What is Atrial Fibrillation (AFib)?

Atrial Fibrillation (AFib) is a type of arrhythmia where the heart rhythm is irregular and often very fast. During an AFib episode, the upper chambers of the heart (atria) beat chaotically and irregularly. AFib can lead to blood clots in the heart, increasing the risk of serious health problems like stroke, transient ischemic attacks (TIA), heart failure, and other cardiac complications.

AFib Detection

The OMRON IntelliSense AFib technology alerts you to the possibility of AFib, even after a single measurement. It detects irregularities in the pulse intervals. This is a screening function and does not provide a diagnosis. It does not continuously monitor your heart and may not detect all forms of AFib. If the irregular rhythm is too slight, it may not be detected. Consult your doctor if the AFib symbol appears or if you have concerns.

AFib Symbol vs. EKG

The AFib symbol indicates a potential finding, while an EKG is a diagnostic tool used by doctors to measure the heart's electrical activity.

Reading Reliability with AFib Symbol

Atrial fibrillation or irregular heart rhythm can affect blood pressure readings. If the irregular rhythm is too severe, an error message (E5) may appear. Repeated errors suggest consulting a doctor.

10. Contact and Support

For support, service, or warranty claims, please contact your retailer or visit the OMRON Healthcare website: www.omron-healthcare.com

Device Components

The monitor includes:

• Display: Digital LCD screen.
• [Memory/Connection Button]: For accessing memory and connection features.
• [User ID Buttons]: To select User 1 or User 2.
• [START/STOP Button]: To start and stop measurements.
• Air Jack: Connection point for the air tubing.
• AC Adapter Jack: For connecting an optional AC adapter.
• Battery Compartment: Houses the AA batteries.
• Air Plug: Connects the air tubing to the cuff.
• Air Tube: Connects the cuff to the monitor.

Operational Instructions Summary

Before Use: Read both manuals. Relax for 5 minutes. Avoid stimulants and strenuous activity for 30 minutes.

Setup: Insert batteries, download the OMRON connect app, pair the device via Bluetooth.

Measurement:

1. Select User ID.
2. Apply cuff correctly (1-2 cm above elbow crease, tube on inside of arm, snug fit).
3. Sit correctly (supported back/arm, cuff at heart level, feet flat, legs uncrossed).
4. Press [START/STOP]. Remain still and do not talk during measurement.
5. Readings are saved automatically. Transfer to app via Bluetooth.

AFib Detection: The AFib symbol [AFib symbol] may appear if atrial fibrillation is suspected. Consult your doctor.

Three-time Mode: Takes 3 readings with 30-second intervals for an average.

Guest Mode: For single measurements without saving data.

Checking Readings: Look for indicators for high blood pressure, irregular rhythm, body movement, cuff tightness, or AFib possibility.

Maintenance and Warranty Summary

Maintenance: Keep clean and dry. Store in a safe place. Clean with a soft, damp cloth.

Warranty: OMRON offers a 5-year warranty. Refer to product documentation for details.

Specifications Summary

• Model: M4 Connect AFib (HEM-7196T1-FLE)
• Type: Automatic Upper Arm Blood Pressure Monitor
• Connectivity: Bluetooth® Low Energy
• Power: 4x AA Batteries or AC Adapter
• Arm Circumference: 22-42 cm
• Memory: 60 readings per user

Key Symbols

• CE Mark: European conformity.
• UKCA Mark: UK conformity.
• [AFib Symbol]: Potential AFib detection.
• [Bluetooth Symbol]: Bluetooth enabled.
• [Consult Manual Symbol]: Refer to instructions.
• [Latex Free Symbol]: Contains no natural rubber latex.

Legal and Compliance

EMC: Complies with EN 60601-1-2. Manufacturer: OMRON HEALTHCARE Co., Ltd. Trademarks: Bluetooth®, Apple, Google Play are registered trademarks. Disposal: Recycle according to WEEE guidelines.

Document Information

Issue Date: 2024-12-03