OMRON EVOLV Automatic Arm Blood Pressure Monitor

Introduction

Thank you for purchasing the OMRON EVOLV Automatic Arm Blood Pressure Monitor. This device uses an oscillometric method to measure blood pressure and pulse. It is designed for ease of use and provides digital readings.

Intended Use

This digital blood pressure monitor is intended for measuring blood pressure and pulse in adult patients. It detects and indicates irregular heartbeats during measurement. The product is primarily for home use.

Important Safety Information

Warning: Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

• Do not change medication based on the measurement results. Consult your doctor for diagnosis and treatment.
• Do not use the device on an injured arm or an arm undergoing medical treatment.
• Do not apply the cuff to an arm with an intravenous drip or blood transfusion.
• Do not apply or inflate the cuff around any body part other than the arm.
• Do not use the device in areas with high-frequency surgical equipment, MRI equipment, CT scanners, or in oxygen-rich environments.
• Do not use this device on infants, small children, or persons unable to express themselves.
• Consult your doctor before using this device if you have frequent arrhythmias, aortic stenosis, peripheral arterial disease, diabetes, pregnancy, pre-eclampsia, or kidney disease.
• Small parts may pose a choking hazard to infants and children.
• Keep batteries out of reach of infants and children.
• The device emits radio frequency (RF) waves. Do not use in areas where RF-emitting devices are restricted, such as airplanes or hospitals.

Caution: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user/patient or damage to the device/other property.

• Discontinue use and consult your doctor if skin irritation or discomfort occurs.
• Consult your doctor before using this device on an arm with an arteriovenous fistula.
• Patient movement, trembling, or shivering may affect the measurement reading.
• Consult your doctor before use if you are a mastectomy patient.
• Consult your doctor before using the monitor if you have severe blood circulation problems or blood diseases, as cuff inflation may cause bruising.
• Do not take measurements more often than necessary, as this may cause bruising due to interruption of blood flow.
• If the cuff does not deflate during measurement, remove it.
• Do not use the monitor for any purpose other than measuring blood pressure.
• Ensure no mobile devices or other electrical devices emitting electromagnetic waves are within 30 cm of the monitor during measurement.
• Do not use the device simultaneously with other electrical medical equipment.
• Do not disassemble or attempt to repair the monitor or its parts.
• Do not use the monitor in damp locations or where it may get wet.
• Do not use the monitor in a moving vehicle.
• Do not drop the monitor or expose it to strong shocks or vibrations.
• Do not use the monitor in environments with extreme humidity or temperature.
• Observe the arm during measurement to ensure blood flow is not impaired.
• Do not use the monitor in environments requiring frequent use, such as medical facilities.
• Do not bathe, drink alcohol or caffeine, smoke, exercise, or eat for 30 minutes before measurement.
• Rest for at least 5 minutes before measurement.
• Remove tight clothing or thick fabric/wool from the arm.
• Do not move or talk during measurement.
• Refer to the "Electromagnetic Compatibility (EMC)" section in Chapter 6.
• Refer to the "Proper Disposal of this Product" section in Chapter 6 for disposal instructions.
• If the monitor is stored at extreme temperatures and moved to a 20°C environment, wait approximately 2 hours before use.

Data Transmission

• Do not replace batteries during data transmission to a smart device.
• Do not place IC cards, magnets, metal objects, or other devices generating electromagnetic fields near the monitor during data transmission.

Battery Handling

• Insert batteries with correct polarity.
• Use only four AAA alkaline batteries. Do not mix new and used batteries.
• Remove batteries if the monitor will be unused for an extended period.
• If electrolyte gets into eyes, rinse immediately with plenty of clean water and seek medical advice.
• If electrolyte gets on skin, rinse immediately with plenty of clean, lukewarm water. Seek medical advice if irritation persists.
• Do not use batteries beyond their expiration date.
• Periodically check batteries for damage.
• Use only batteries specified for this monitor.

1. Device Structure

Contents

Blood pressure monitor, battery set, instruction manual, setup guide, storage case.

Display Symbols

• Irregular Heartbeat Symbol ( ): Indicates an irregular heartbeat detected at least twice during measurement. Consult your doctor if this symbol appears.
• Movement Error Symbol ( ): Indicates movement during measurement. Remove the cuff, wait 2-3 minutes, and repeat the measurement without moving.
• Cuff Fit Error Indicator Symbol ( / ): Indicates if the cuff is too loose ( ) or fits correctly ( ).
• SYNC Symbol ( ): Indicates synchronization status with a smart device or data transmission. Data should be transmitted before clearing measurements. The internal memory holds up to 100 measurements.

ESH/ESC Guidelines for the Management of Arterial Hypertension 2013

Definitions of hypertension in clinical and home settings are statistical blood pressure values.

1.2 Before Measurement

For accurate readings, follow these guidelines:

1. Do not bathe, drink alcohol or caffeine, smoke, exercise, or eat for 30 minutes before measurement.
2. Rest for at least 5 minutes before measurement.
3. Avoid measuring blood pressure during stressful times.
4. Measure in a quiet place.
5. Remove tight clothing from the arm.
6. Record blood pressure and pulse readings and share them with your doctor. Consistent daily measurements at the same time are recommended.

2. Preparation

2.1 Inserting Batteries

1. Remove the battery cover.
2. Insert 4 AAA batteries according to the polarity indicated.
3. Replace the battery cover.

Notes:

• If the low battery symbol ( ) appears, replace all four batteries with new ones. Extended life alkaline batteries are recommended.
• Measurement values remain stored in memory even after battery replacement.
• Dispose of batteries according to national/local regulations.

2.2 Pairing the Monitor with a Smart Device

Date and time on the monitor will be set automatically after pairing with a smart device. Download and install the "OMRON connect" app for setup instructions.

1. Enable Bluetooth® on your smart device.
2. Download and install the free "OMRON connect" app.
3. Launch the app and follow the device setup and pairing instructions.
4. Check for a successful connection (display shows "OK"). If "Err" appears, refer to the troubleshooting section.

Notes:

• Using an app other than "OMRON connect" may prevent automatic date and time setting.
• OMRON is not responsible for data loss.
• If using the monitor without pairing, refer to section "3.3 Taking a Measurement".

3. Using the Device

3.1 Applying the Cuff

Remove tight clothing from the left arm. Do not place the cuff over thick clothing.

1. Apply the cuff to the left arm, 1 to 2 cm above the elbow. Ensure the display is positioned for easy reading.
2. Secure the cuff firmly with the hook-and-loop fastener.

Notes:

• Blood pressure may differ between the left and right arms. OMRON recommends measuring on the same arm consistently. Consult your doctor if readings differ significantly.
• Position the [START/STOP] button towards your body for easier operation.

3.2 Correct Posture

Sit comfortably at room temperature. Keep legs uncrossed, feet flat on the floor, and back supported. Ensure the cuff on the arm is at heart level.

3.3 Taking a Measurement

Notes:

• Press [START/STOP] once to stop measurement and deflate the cuff.
• Do not move or talk during measurement.
• The monitor can store 100 measurements. View all recorded measurements using the "OMRON connect" app.
• Do not use the monitor simultaneously with other electrical devices.

1. Press the [START/STOP] button. The cuff will inflate.
2. The cuff fit indicator will display during measurement ( : correctly fitted, : too loose or incorrectly applied).
3. Remove the cuff after measurement.
4. Transmit Readings: Ensure the monitor is within 5 m (16 ft) of your smart device and the "OMRON connect" app is active. Readings are automatically transmitted after measurement.

Later Transmission of Readings:

1. Launch the "OMRON connect" app and follow the instructions.
2. Press the connection button to transmit readings.

Notes:

• If the SYNC symbol ( ) appears, transmit data before clearing readings.
• If the connection loss symbol (OFF) ( ) appears, enable Bluetooth on the monitor (see section 3.4).
• Once readings are sent to the app, they cannot be resent.

After transmitting readings to the "OMRON connect" app, press [START/STOP] to turn off the monitor. The monitor turns off automatically after 2 minutes. Wait 2-3 minutes between measurements.

Multiple Smart Device Data Transmission: Data cannot be resent to the same or another smart device after transmission.

Multiple Users: The monitor is for personal use. Measurement data will be combined if used by multiple people.

Using the Monitor Without Pairing:

1. Apply the cuff (Section 3.1).
2. Press the [START/STOP] button (Steps 1-2 in Section 3.3).
3. Record SYS/DIA readings, pulse, date, and time on paper to keep a measurement history. Earlier readings stored in memory cannot be viewed on the monitor without a smart device.

3.4 Turning Off Bluetooth®

Turn off Bluetooth® in locations where wireless devices are prohibited.

1. Turn off the monitor if it is on.
2. Press and hold the connection button for over 10 seconds.
3. Release the connection button when the symbol ( ) appears on the display.
4. Press [START/STOP] to turn off the monitor.

Turning On Bluetooth®: Press and hold the connection button for over 2 seconds while the power is off. Release the button when the symbol ( ) appears.

3.5 Restoring Monitor to Default Settings

To erase all stored information:

1. With the monitor off, press and hold the connection button. The connection symbol ( ) and "P" will appear. Then press and hold the [START/STOP] button for over 5 seconds.
2. Release both buttons when the "Clr" symbol appears.
3. Press [START/STOP] to turn off the monitor.

Notes:

• Restoring default settings does not erase information in the app.
• If reusing the monitor, remove its registration from the app and re-pair.

4. Error Messages and Troubleshooting

4.1 Error Messages

4.2 Troubleshooting

5. Maintenance and Storage

5.1 Maintenance

• Store the device and its parts in a clean, safe place.
• Do not use abrasive or volatile cleaning agents.
• Do not wash the cuff or immerse it in water.
• Clean the monitor and cuff with a soft, dry cloth or a soft cloth dampened with a neutral soap solution, then wipe dry.
• Unauthorized modifications void the warranty. Do not disassemble or attempt repairs.

Calibration and Servicing

The accuracy of this monitor has been carefully tested. For continued accuracy, it is recommended to have the device inspected every 2 years. Contact your point of sale or OMRON distributor.

5.2 Storage

Do not store the device in the following conditions:

• When the device is wet.
• In locations exposed to extreme temperatures, humidity, direct sunlight, dust, or fumes (e.g., bleach).
• In locations subject to vibration and shock. Avoid tilting the device.

6. Technical Specifications

Notes:

• Specifications are subject to change without notice.
• The monitor is designed according to European standard EN1060 and complies with Directive 2014/53/EU.
• The pressure sensor, a critical component, is manufactured in Japan.
• Report any serious incident to the manufacturer and the competent authority of the member state.
• Use the monitor only in EU member states or its country of purchase.

7. Trademarks

Bluetooth® word marks and logos are registered trademarks owned by Bluetooth SIG, Inc. Use of such marks by OMRON HEALTHCARE Co., Ltd. is under license. Other trademarks and trade names are those of their respective owners.

Apple names and logos are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Android, Google Play logos are trademarks of Google Inc.

8. Limited Warranty

This product is covered by a 5-year OMRON warranty from the date of purchase. OMRON warrants the proper design, workmanship, and materials of this product. During this warranty period, OMRON will, free of charge for parts or labor, repair or replace any defective product or part.

The warranty does not cover:

• Transportation costs and risks associated with transport.
• Costs of repairs and/or defects resulting from repairs carried out by unauthorized persons.
• Periodic checks and maintenance.
• Failure or wear of optional parts or accessories other than the main unit, unless specified otherwise.
• Costs resulting from the rejection of a warranty claim (a fee will be charged for this).
• Damages of any other kind, including personal injury, caused by accident or misuse.
• Calibration service.

For warranty claims, contact the seller or an authorized OMRON distributor. Warranty repairs or replacements do not extend or renew the warranty period. The warranty is valid only when the complete product is returned with the original sales receipt.

9. Useful Information About Blood Pressure

What is Blood Pressure?

Blood pressure is the force exerted by circulating blood on the walls of arteries. Arterial blood pressure constantly changes during the cardiac cycle. The highest pressure is systolic blood pressure; the lowest is diastolic blood pressure. Both readings are essential for assessing a patient's blood pressure status.

What is Arrhythmia?

Arrhythmia is a condition in which the heart rhythm is irregular due to defects in the bio-electrical system that governs heartbeats. Symptoms include skipped beats, premature contractions, or unusually fast (tachycardia) or slow (bradycardia) pulse rates.

What are the Benefits of Measuring Blood Pressure at Home?

Blood pressure can be affected by various factors such as physical activity, nervousness, or time of day. A single measurement may not be sufficient for diagnosis. Measuring daily at the same time provides a more accurate indication of blood pressure changes. Blood pressure is typically lower in the morning and rises from afternoon to evening. It is lower in summer and higher in winter.

How is Hypertension Related to Stroke?

Hypertension (high blood pressure) is the main risk factor for stroke. Effective treatment for patients with hypertension can prevent approximately one in four strokes caused by hypertension. Guidelines recommend using home blood pressure monitors in addition to clinic measurements for effective hypertension management.

Symbols Description

• Type BF applied part
• Degree of protection against electric shock (leakage current)
• Class II Equipment. Protection against electric shock
• Protection degree according to IEC 60529
• CE Marking
• UKCA Marking
• Metrology Symbol
• EC Symbol
• Serial Number
• Batch Number
• Unique Device Identifier
• Medical Device
• Temperature Limitations
• Humidity Limitations
• Atmospheric Pressure Limitations
• Connector Polarity
• Indoor Use Only
• OMRON's trademarked blood pressure measurement technology
• Method for identifying cuffs compatible with the device
• Cuff placement indicator for the left arm
• Mark on the cuff indicating position over the artery
• Range indicator and position adjustment for the brachial artery
• Manufacturer Quality Control Mark
• Manufactured without the use of natural rubber latex
• Arm circumference indicator to help select the correct cuff size.
• User must read this instruction manual.
• For safety, the user must strictly follow this instruction manual.
• Direct Current
• Alternating Current
• Date of Manufacture
• OMRON Healthcare Japan Technology
• Symbol for generally elevated exposure levels of non-ionizing radiation or designation of devices or systems, e.g., medical electrical equipment, that include radio frequency transmitters or intentionally use electromagnetic energy for diagnosis or therapy.
• Arm Circumference
• Wrist Circumference
• OMRON connect - an application for transferring measurement data to a smart device.

Important Information Regarding Electromagnetic Compatibility (EMC)

The HEM-7600T-E device complies with the electromagnetic compatibility (EMC) requirements of EN60601-1-2:2015. Further EMC compliance documentation is available from OMRON HEALTHCARE EUROPE or at www.omron-healthcare.com.

Information on Wireless Communication Interference: The product operates in the 2.4 GHz ISM band. If used near other wireless devices operating in the same frequency band (e.g., microwave ovens, wireless LAN), interference may occur. If interference occurs, discontinue use of other devices, move the product, or use it away from wireless devices.

Proper Disposal of this Product (Waste Electrical and Electronic Equipment)

This marking indicates that the product should not be disposed of with household waste at the end of its life. To prevent environmental pollution or harm to human health, separate this product from other waste types and recycle it responsibly to promote the reuse of material resources.

For household users: Contact the retailer or local government for details on environmental recycling.

For business users: Contact the supplier and check the terms of the purchase agreement. Do not mix this product with other commercial waste for disposal.

Manufacturer Information

Manufacturer: OMRON HEALTHCARE Co., Ltd., 53, Kunotsubo, Terado-cho, Muko, KYOTO, 617-0002 JAPAN

EU Representative: OMRON HEALTHCARE EUROPE B.V., Scorpius 33, 2132 LR Hoofddorp, NETHERLANDS

UK Importer and Responsible Person: OMRON HEALTHCARE UK LTD., Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, UK

Made in Japan