OMRON EVOLV Automatic Upper Arm Blood Pressure Monitor

Important Safety Information

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

• Do not adjust medication based on measurement results. Consult your physician for diagnosis and treatment.
• Do not use on an injured arm or an arm under medical treatment.
• Do not wear the arm cuff during an intravenous drip or blood transfusion.
• Do not apply or inflate the arm cuff around any body parts other than your upper arm.
• Do not use in areas with high frequency (HF) surgical equipment, MRI, CT scanners, or in oxygen-rich environments.
• Do not use on infants, toddlers, children, or persons who cannot express themselves.
• Consult your physician if you have common arrhythmias, arterial sclerosis, poor perfusion, diabetes, pregnancy, pre-eclampsia, or renal disease.
• Self-diagnosis and self-treatment are dangerous. Always consult your physician.
• Contains small parts that may cause a choking hazard if swallowed by children.
• Keep batteries out of the reach of children.
• Do not use this product in locations where RF is restricted, such as on an aircraft or in hospitals.

Caution: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury or damage to equipment.

• Stop using and consult your physician if you experience skin irritation or discomfort.
• Consult your physician before using on an arm with an arterio-venous (A-V) shunt.
• Patient motion, trembling, or shivering may affect the measurement reading.
• Consult your physician before using if you have had a mastectomy.
• Consult your physician before using if you have severe blood flow problems or blood disorders, as cuff inflation can cause bruising.
• Do not take measurements more often than necessary to avoid bruising.
• Remove the arm cuff if it does not start deflating during measurement.
• Do not use for any purpose other than measuring blood pressure.
• Ensure no mobile or other electrical devices emitting electromagnetic fields are within 30 cm during measurement.
• Do not use with other medical electrical (ME) equipment simultaneously.
• Do not disassemble or attempt to repair the monitor.
• Do not use in wet areas or where splashing may occur.
• Do not use in a moving vehicle.
• Do not drop, or subject to strong shocks or vibrations.
• Do not use in places with extreme humidity or temperatures.
• Check the arm for any impairment of blood circulation.
• Do not use in high-use environments like medical clinics or physician offices.
• Avoid bathing, drinking alcohol or caffeine, smoking, exercising, and eating for 30 minutes before measurement.
• Rest for at least 5 minutes before measurement.
• Remove tight-fitting or thick clothing from your arm.
• Remain still and do not talk during measurement.
• Read and follow the “Important information regarding Electromagnetic Compatibility (EMC)” in section 6.
• Read and follow the “Correct Disposal of This Product” in section 6 when disposing of the device.
• If the monitor is stored at extreme temperatures and moved to 20°C, wait approximately 2 hours before use.

Data Transmission: Do not replace batteries during data transfer. Keep integrated circuit cards, magnets, or metal objects away from the monitor during data transfer.

Battery Handling: Use only 4 “AAA” alkaline batteries. Do not mix new and used batteries. Remove batteries if the monitor will not be used for a long period. If battery fluid gets in eyes, rinse immediately with plenty of water and consult a physician. If it gets on skin, wash with water and consult a physician if irritation persists. Do not use expired batteries. Periodically check batteries.

1. Know Your Device

Contents: Monitor, battery set, instruction manual, setup instructions, soft case.

Monitor Components:

• Display symbols:
• Irregular Heartbeat Symbol ( appears when an irregular rhythm is detected two or more times during measurement. Consult your physician if this symbol appears. )
• Movement Error Symbol ( displayed if you move during measurement. Remove cuff, wait 2-3 minutes, and re-measure. )
• Cuff Wrap Guide Symbol ( appears if the cuff is wrapped too loosely. )
• SYNC Symbol ( appears when the monitor needs to pair with a smart device or transfer data. Transfer data before measurements are deleted. Maximum internal memory is 100 measurements. )

Definitions of hypertension (2013 ESH/ESC Guidelines):

Device Diagram:

• A. START/STOP button
• B. Connection button
• C. Display
• D. Arm cuff
• E. Battery compartment
• F. Systolic blood pressure display
• G. Diastolic blood pressure display
• H. Pulse display

Display Information:

• Irregular Heartbeat
• Normal Heartbeat
• Pulse
• Blood pressure (Systolic/Diastolic)
• SYNC symbol: Ensure connection button is pressed to pair or transfer data when SYNC symbol appears.

Important Reminders:

• Do not adjust medication based on measurement results. Consult your physician.
• Always consult your physician. Self-diagnosis is dangerous.

Measurement Status Indicators:

• START INFLATING
• DEFLATING
• COMPLETED

Compatibility: Review compatible smart devices at omronconnect.com/devices. For details, visit omronconnect.com.

Cuff Placement: The bottom edge of the arm cuff should be 1 to 2 cm above the elbow.

2. Preparation

2.1 Battery Installation

1. Remove the battery cover by gently slipping into the gap of the hook and pulling downward.
2. Insert 4 “AAA” batteries as indicated into the battery compartment.
3. Replace the battery cover.

Notes:

• When the depleted battery symbol () appears, replace all 4 batteries with new ones simultaneously. Long-life alkaline batteries are recommended.
• Measurement values are stored in memory even after battery replacement.
• Disposal of used batteries must comply with national/local regulations.

2.2 Pairing Your Monitor with a Smart Device

The date and time on your monitor will automatically set upon pairing with your smart device.

1. Turn on the Bluetooth® feature of your smart device.
2. Download and install the free “OMRON connect” app on your smart device. (For first-time use, visit omronconnect.com/setup for initial setup instructions.)
3. Open the app and follow the set-up and pairing instructions.
4. Confirm the monitor is connected successfully. “OK” will appear on the display if connected. “Err” indicates a connection failure (refer to section 4.2).

Notes:

• Using other apps may prevent automatic date/time setting. Use the “OMRON connect” app for pairing or data transfer to set date/time.
• Date/time is set for future measurements after the transferred one.
• OMRON is not responsible for data loss.
• For use without pairing, refer to section 3.3.

3. Using the Device

3.1 Applying the Arm Cuff

• Remove tight-fitting clothing from your left upper arm. Do not place the cuff over thick clothes.
• Apply the arm cuff to your left upper arm. The bottom edge should be 1 to 2 cm above the elbow. Position the display for easy viewing.
• Securely close with the fabric fastener.

Notes:

• Blood pressure can differ between arms. Use the same arm for measurements. Consult your physician if values differ substantially.
• Position the monitor with the [START/STOP] button towards your body for easier use.

3.2 How to Sit Correctly

• Sit in a chair with legs uncrossed and feet flat on the floor.
• Sit with your back and arm supported.
• The arm cuff should be at the same level as your heart.

3.3 Taking a Measurement

• Press the [START/STOP] button. The arm cuff will inflate.
• The cuff wrap guide result ( or ) appears during measurement.
• If error symbols appear, remove the cuff, wait 2-3 minutes, and re-measure, remaining still.
• Remove the arm cuff after measurement.
• Transfer your readings: Ensure the monitor is within 5 m (16 ft.) of your smart device and the “OMRON connect” app is active. Readings transfer automatically. To transfer later, open the app and follow instructions. “OK” flashes if successful; “Err” indicates failure (see section 4.2).

Notes:

• Transfer data immediately when the SYNC symbol () appears.
• If the Connection OFF symbol () appears, turn on Bluetooth on your monitor (section 3.4).
• Once sent, readings cannot be resent.
• Wait 2-3 minutes between measurements for arteries to recover.
• Using other apps may cause incorrect data display after sending.

Data Transfer With Multiple Smart Devices: Data transferred once cannot be transferred again to the same or another device.

About Multiple Users: This monitor is recommended for personal use. Combined data will be displayed if used by multiple people.

Using your Monitor without Pairing:

1. Apply the arm cuff (section 3.1).
2. Press [START/STOP] button (steps 1-2 in section 3.3).
3. Write down SYS/DIA and Pulse readings, date, and time on paper.

Note: Prior readings stored in memory are not viewable on the monitor without a smart device.

3.4 Turning “OFF” Bluetooth®

Turn off Bluetooth in prohibited areas (aircraft, hospitals, abroad).

1. Turn monitor power off.
2. Press and hold the connection button for over 10 seconds until “” appears.
3. Release the button.
4. Press [START/STOP] to turn off the monitor.

How to turn “ON” Bluetooth®: With the power off, press and hold the connection button for over 2 seconds until “” appears. Release the button.

3.5 Restoring Your Monitor to the Default Settings

To delete all stored information:

1. With the monitor off, hold the connection button down, then press the [START/STOP] button for over 5 seconds.
2. When “Clr” appears, release both buttons.
3. Press [START/STOP] to turn off the monitor.

Notes:

• Restoring settings does not delete data in the app.
• When reusing, delete the monitor registration in the app first, then pair again.

4. Error Messages and Troubleshooting

4.1 Error Messages

4.2 Troubleshooting

5. Maintenance and Storage

5.1 Maintenance

• Store the device and components in a clean, safe location.
• Do not use abrasive or volatile cleaners.
• Do not wash or immerse the device or components in water.
• Do not use gasoline, thinners, or similar solvents for cleaning.
• Clean the monitor and arm cuff with a soft dry cloth, or a soft cloth moistened with neutral soap, then wipe dry.
• Modifications not approved by the manufacturer void the warranty. Do not disassemble or attempt repairs.

Calibration and Service:

The device is designed for a long service life. Inspection every 2 years is recommended. Consult your OMRON retailer or distributor.

5.2 Storage

• Do not store if the device is wet.
• Avoid locations exposed to extreme temperatures, humidity, direct sunlight, dust, or corrosive vapors.
• Avoid locations exposed to vibrations, shocks, or at an angle.

6. Specifications

Symbols Description:

• Applied part - Type BF
• Degree of protection against electric shock (leakage current)
• Class II equipment. Protection against electric shock
• Ingress protection degree provided by IEC 60529
• CE Marking
• Metrology symbol
• Symbol of Eurasian Conformity
• Serial number
• LOT number
• Medical device
• Temperature limitation
• Humidity limitation
• Atmospheric pressure limitation
• Indication of connector polarity
• For indoor use only
• OMRON’s trademarked technology for blood pressure measurement
• Identifier of cuffs compatible for the device
• Cuff positioning indicator for the left arm
• Marker on the cuff to be positioned above the artery
• Range pointer and brachial artery alignment position
• Manufacturer's quality control mark
• Not made with natural rubber latex
• Range indicator of arm circumferences to help selection of the correct cuff size.
• Need for the user to consult this instruction manual.
• Need for the user to follow this instruction manual thoroughly for your safety.
• Direct current
• Alternating current
• Date of manufacture
• Technology by OMRON Healthcare in Japan
• Indicates potentially hazardous levels of non-ionizing radiation, or equipment with RF transmitters.
• Arm circumference
• Wrist circumference
• OMRON connect - App for uploading measurement data to smart device.

Electromagnetic Compatibility (EMC):

This product conforms to EN60601-1-2:2015 EMC standard. Refer to OMRON HEALTHCARE EUROPE or www.omron-healthcare.com for further documentation.

Wireless Communication Interference:

This product operates in the 2.4GHz band. Interference may occur with other wireless devices operating on the same frequency. Stop operation of other devices or relocate this product if interference occurs.

Correct Disposal of This Product:

This marking indicates that the product should not be disposed of with household waste. Separate it from other wastes and recycle responsibly to promote sustainable reuse of material resources. Contact the retailer or local government office for details on environmentally safe recycling.

7. Trademarks

Bluetooth® word mark and logos are registered trademarks of Bluetooth SIG, Inc. used under license by OMRON HEALTHCARE Co., Ltd. Apple and the Apple logo are trademarks of Apple Inc. App Store is a service mark of Apple Inc. Android and the Google Play logo are trademarks of Google Inc.

8. Limited Warranty

This product is guaranteed by OMRON for 3 years from the date of purchase. OMRON will repair or replace defective products or parts free of charge for labor and parts during this period.

The guarantee does not cover:

• Transport costs and risks.
• Repairs by unauthorized persons.
• Periodic check-ups and maintenance.
• Failure or wear of optional parts.
• Costs arising due to non-acceptance of a claim.
• Accidental or misuse damages.
• Calibration service.

Contact the dealer or an authorized OMRON distributor for guarantee service. Repair or replacement does not extend the guarantee period. The complete product must be returned with the original invoice/cash ticket.

9. Some Useful Information about Blood Pressure

What is Blood Pressure?

Blood pressure measures the force of blood against artery walls. Systolic pressure is the highest, and Diastolic pressure is the lowest during the heart's cycle. Both are needed for physician evaluation.

What is Arrhythmia?

Arrhythmia is an abnormal heartbeat rhythm due to flaws in the heart's electrical system. Symptoms include skipped heartbeats, premature contractions, or abnormally fast/slow pulse.

Why Measure Blood Pressure at Home?

Factors like physical activity, anxiety, and time of day influence blood pressure. A single measurement may not be sufficient for accurate diagnosis. Measuring at the same time daily provides an accurate indication of changes. Blood pressure is typically lower in the morning and higher in the evening, and lower in summer than winter.

How is Hypertension related to Stroke?

Hypertension (high blood pressure) is a key risk factor for stroke. Effective treatment can prevent strokes. Home blood pressure monitoring is endorsed to help manage hypertension effectively.

References to medical claims are available upon request.