OMRON Evolv Upper Arm Blood Pressure Monitor

Introduction

Thank you for purchasing the OMRON BP7000 Blood Pressure Monitor. Your new blood pressure monitor uses the oscillometric method of blood pressure measurement. This means the monitor detects your blood movement through your brachial artery and converts the movements into a digital reading. An oscillometric monitor does not need a stethoscope, making it simple to use. For symbol information, visit: OmronHealthcare.com/symbols-glossary

Intended Use

This device is a digital monitor intended for use in measuring blood pressure and pulse rate in the adult patient population with arm circumference ranging from 9 inches to 17 inches (22 cm to 42 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Important Safety Information

Please read the Important Safety Information in this instruction manual before using the unit. Please follow this instruction manual thoroughly for your safety. Please keep for future reference. For specific information about your own blood pressure, CONSULT YOUR PHYSICIAN.

Contraindications

• The device is contraindicated for use in ambulatory environments.
• The device is contraindicated for use on aircraft.

▲ 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 from this blood pressure monitor. Take medication as prescribed by your physician. Only a physician is qualified to diagnose and treat high blood pressure.
• DO NOT use this monitor on an injured arm or an arm under medical treatment.
• DO NOT wear the arm cuff on your arm while on 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 this monitor in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, computerized tomography (CT) scanners or in oxygen rich environments.
• DO NOT use this monitor on infants, toddlers, children or persons who cannot express themselves.
• Consult your physician before using this monitor if you have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation; arterial sclerosis; poor perfusion; diabetes; pregnancy; pre-eclampsia; or renal disease. Note that any of these conditions in addition to patient motion, trembling, or shivering may affect the measurement reading.
• Always consult your physician. Self-diagnosis of measurement results and self-treatment are dangerous.
• Contains small parts that may cause a choking hazard if swallowed by children, toddlers or infants.
• Keep the BATTERY out of the reach of children, toddlers and infants.

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

• This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product in locations where RF is restricted, such as on an aircraft or in hospitals. For further information on any potential restrictions refer to documentation on Bluetooth® usage by the FCC.
• Stop using this monitor and consult your physician if you experience skin irritation or discomfort.
• Consult your physician before using this monitor on an arm with an arterio-venous (A-V) shunt.
• Consult your physician before using this monitor if you have had a mastectomy.
• Consult your physician before using the monitor if you have severe blood flow problems or blood disorders as cuff inflation can cause bruising.
• Do not take measurements more often than necessary because bruising, due to blood flow interference, may occur.
• Remove the arm cuff if it does not start deflating during the measurement.
• Do not use this monitor for any purpose other than measuring blood pressure.
• Do not use a mobile phone or other electrical devices that emit electromagnetic fields near this monitor except when transferring your readings to your smart device. This may result in incorrect operation of this monitor.
• Do not disassemble or attempt to repair the monitor or components. This may cause an inaccurate reading.
• Do not use in a location where there is moisture or a risk of water splashing the monitor. This may damage the monitor.
• Do not use this monitor in a moving vehicle such as in a car.
• Do not drop, or subject this monitor to strong shocks or vibrations.
• Do not use this monitor in places with high or low humidity or high or low temperatures. See the “8. SPECIFICATIONS” section of the manual.
• Please check, by observation of the arm being used, that the monitor is not causing any impairment of patient blood circulation.
• Do not use this monitor in high-use environments such as medical clinics or physician offices.
• Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating for 30 minutes before taking a measurement.
• Rest for at least 5 minutes before taking the measurement.
• Remove tight-fitting or thick clothing from your arm while taking a measurement.
• Remain still and do not talk while taking a measurement.

Data Transmission

• Do not replace the battery while your reading is being transferred to your smart device. This may result in the incorrect operation of your monitor and failure to transfer your blood pressure data.
• Do not place integrated circuit cards, magnets, metal objects, or other devices that emit electromagnetic fields near this monitor while your reading is being transferred to your smart device. This may result in the incorrect operation of your monitor and failure to transfer your blood pressure data.

Battery Handling and Usage

• Do not insert the batteries with their polarities incorrectly aligned.
• Use only 4 “AAA” alkaline batteries with this monitor. Do not use other types of batteries. Do not use new and used batteries together.
• Remove the batteries if the monitor will not be used for a long period of time.
• If battery fluid should get in your eyes, immediately rinse with plenty of clean water. Consult a physician immediately.
• If battery fluid should get on your skin, wash your skin immediately with plenty of clean, lukewarm water. If irritation, injury or pain persists, consult a physician.
• Do not use batteries after their expiration date.
• Periodically check your batteries to ensure they are in good working condition.
• Only use batteries specified for this monitor. Use of unsupported batteries may damage and/or may be hazardous to the monitor.

1. Know Your Monitor

Contents: Monitor, 4 “AAA” batteries, instruction manual, quick start guide

Monitor Components

The monitor includes the following parts:

• A. START/STOP button: Used to start and stop measurements.
• B. Connection button: Used for Bluetooth connectivity.
• C. Display: Shows measurement results and status indicators.
• D. Arm cuff: The inflatable cuff that wraps around the upper arm.
• E. Battery compartment: Houses the batteries for the monitor.

Display Indicators:

• F. Systolic blood pressure: The higher number in a blood pressure reading.
• G. Diastolic blood pressure: The lower number in a blood pressure reading.
• H. Pulse display: Shows the pulse rate per minute.

Display Symbols

• Connection symbol (): Appears when transferring data or pairing with a smart device.
• Connection OFF symbol (): Appears when Bluetooth is off.
• Connection ON symbol (): Appears when Bluetooth is on.
• Movement error symbol (): Displays when the body is moving during measurement. If this symbol appears, remove the monitor, wait 2-3 minutes, and take another measurement while remaining still.
• SYNC symbol (): Indicates data synchronization. Ensure the monitor is paired with the smart device or transfer data. Data is stored internally for up to 100 measurements; older data is deleted when new data is added.
• Irregular heartbeat symbol (): Appears when the monitor detects an irregular rhythm two or more times during measurement. An irregular rhythm is defined as a rhythm that is 25% less or 25% more than the average rhythm. If this symbol appears, consult your physician.
• Battery symbol (low) (): Appears when batteries are low.
• Battery symbol (depleted) (): Appears when batteries are depleted.
• Deflation symbol (): Flashes while the arm cuff is deflating.
• Heartbeat symbol (): Flashes while taking a measurement.

Classification of BP (Blood Pressure)

According to ACC/AHA 2017 Hypertension guidelines:

* Individuals with Systolic BP and Diastolic BP in 2 categories should be designated to the higher BP category. BP indicates blood pressure based on an average of ≥2 careful readings obtained on ≥2 occasions.

Source: ACC/AHA 2017 High Blood Pressure Clinical Practice Guideline

Before Taking a Measurement

To help ensure an accurate reading, follow these directions:

• Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating for 30 minutes before taking a measurement.
• Rest for at least 5 minutes before taking the measurement.
• Stress raises blood pressure. Avoid taking measurements during stressful times.
• Measurements should be taken in a quiet place.
• Keep a record of your blood pressure and pulse readings for your physician. A single measurement does not provide an accurate indication of your true blood pressure. You need to take and record several readings over a period of time. Try to measure your blood pressure at the same time each day for consistency.

2. Preparation

2.1 Battery Installation

1. Remove the battery cover: Insert your fingernail into the slot of the battery cover and push downwards to remove the cover.
2. Insert battery: Slide the battery over so it is secured inside the circular battery positioner. Then insert the second battery. Ensure correct polarity (+/-).
3. Replace the battery cover.

When batteries are securely placed, the monitor may display "Hello!" followed by "Please use App to manage your data.".

Notes on Batteries:

• When the depleted battery symbol () appears, replace all 4 batteries with new ones. Long-life alkaline batteries are recommended.
• Measurement values are stored in memory even after battery replacement.
• Supplied batteries may have a shorter life than new ones.
• Dispose of used batteries according to national/local regulations.
• After replacing batteries, the display may show "Please pair this device." or "Pairing not completed. No data transfer.". Press the [] button to pair or transfer data.

2.2 Applying the Arm Cuff

Remove tight-fitting or thick clothing from your arm while taking a measurement.

1. Apply the arm cuff to your left upper arm. The bottom edge of the arm cuff should be 1/2 inch (1 to 2 cm) above the elbow. The display should be in clear view and easy to read, positioned slightly on the inside of your arm.
2. Securely close with the fabric fastener.

Notes on Arm Cuff:

• Blood pressure can differ between the right and left arm. Omron recommends using the same arm for measurements. If values differ substantially, consult your physician.
• Positioning the monitor with the [START/STOP] button toward the body makes it easier to use.

2.3 How to Sit Correctly

To take a measurement, you need to be relaxed and comfortably seated at a comfortable room temperature.

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

3. Using the Monitor Without a Smart Device

You can use this blood pressure monitor without pairing to a smart device.

3.1 Taking a Measurement

Notes:

• To stop the measurement, press the [START/STOP] button once to deflate the arm cuff.
• Remain still and do not talk while taking a measurement.
• When using without a smart device, you cannot view prior readings stored in memory.
• Do not use the monitor with any other electrical device simultaneously, as this may result in incorrect operation.

1. Press the [START/STOP] button. The arm cuff will start to inflate.

Measurement Process:

• START (0 mmHg) → INFLATING () → DEFLATING → COMPLETED (SYS [Systolic BP], DIA [Diastolic BP], PULSE [Pulse Rate])

Incorrect Measurement Symbols:

If "Please remeasure" and any of the following symbols (, ) are displayed, please take another measurement and try again.

1. Remove the arm cuff.
2. Write down your SYS/DIA and Pulse readings, along with the date and time of your measurement on a piece of paper to keep a record of your history.

▲ DO NOT adjust medication based on measurement results from this blood pressure monitor. Take medication as prescribed by your physician. Only a physician is qualified to diagnose and treat high blood pressure.

▲ Always consult your physician. Self-diagnosis of measurement results and self-treatment are dangerous.

4. Using the Monitor With a Smart Device

4.1 Pairing Your Monitor with a Smart Device

The date and time on your monitor will automatically be set when you pair it with your smart device.

Review the list of compatible smart devices at: OmronHealthcare.com

1. Enable Bluetooth on your smart device.
2. Scan the QR code or visit OmronHealthcare.com/app to find the OMRON compatible app for this product.
3. Download and install the compatible OMRON app onto your smart device. If you already have the app and an account, open the app and add your new monitor.
4. Open the app and follow the pairing instructions shown on your smart device.
5. Confirm that your monitor is connected successfully. If the monitor is connected successfully, "OK" () will appear on the display. If "Error" () appears, refer to section 5.1 for more detail.

Notes on Pairing:

• If you do not pair this monitor to set the date and time, blood pressure readings will not be transferred.
• The date/time will only be set for future measurements taken after the measurement that was transferred. It will not be saved to the measurement that was just transferred.
• OMRON is not responsible for the loss of data and/or information.

4.2 Taking a Measurement

Notes:

• To stop the measurement, press the [START/STOP] button once to deflate the arm cuff.
• Remain still and do not talk while taking a measurement.
• This monitor stores 100 measurements. Stored measurements cannot be viewed on the monitor's display; use the app to view them.
• Do not use mobile phones or other devices emitting electromagnetic fields near this monitor, except when transferring readings to your smart device, as this may result in incorrect operation.

1. Press the [START/STOP] button. The arm cuff will start to inflate.

Measurement Process:

• START (0 mmHg) → INFLATING () → DEFLATING → COMPLETED (SYS [Systolic BP], DIA [Diastolic BP], PULSE [Pulse Rate])

Incorrect Measurement Symbols:

If "Please remeasure" and any of the following symbols (, ) are displayed, please take another measurement and try again.

1. Remove the arm cuff.
2. Transfer your readings: Make sure your monitor is within 16 ft. (5 m) of your smart device. Open the app on your smart device to transfer readings.

Transferring your readings later:

1. Open the app on your smart device and follow the instructions.
2. Press the [] button to transfer your readings.

If readings are successfully transferred, "OK" () will flash on the display. If "Error" () appears, refer to section 5.1.

Notes on Data Transfer:

• When the SYNC symbol () appears, transfer data immediately before readings are deleted.
• When the Connection OFF symbol () appears, turn on the Bluetooth® feature of your monitor (Refer to section 4.3).
• Once readings are sent to the app, they cannot be sent again.

1. After transferring readings, press the [START/STOP] button to turn the monitor off.

Notes on Monitor Power Off:

• The monitor will automatically turn off after 2 minutes.
• Wait 2-3 minutes before taking another measurement to allow arteries to return to their previous condition.
• Only compatible OMRON apps should be used to ensure correct data transfer.

▲ DO NOT adjust medication based on measurement results from this blood pressure monitor. Take medication as prescribed by your physician. Only a physician is qualified to diagnose and treat high blood pressure.

▲ Always consult your physician. Self-diagnosis of measurement results and self-treatment are dangerous.

Data Transfer With Multiple Smart Devices

Once data is transferred to a smart device, it cannot be transferred again to the same or another smart device.

About Multiple Users

To share your blood pressure monitor with other people, please refer to the "Help" section in the app.

4.3 Turning "OFF" Bluetooth®

Turn off the Bluetooth® in your monitor in areas where wireless equipment is prohibited, such as on aircraft, in hospitals, or while abroad. Your monitor comes with Bluetooth® already turned on.

1. Turn your monitor power off by pressing the [START/STOP] button.
2. Press and hold the [] button for more than 10 seconds. Release the [] button when "" appears on the display. When the "" is blinking, Bluetooth® is now off.
3. Press the [START/STOP] button to turn the monitor off.

Note: The monitor will automatically turn off after 2 minutes.

How to turn "ON" Bluetooth®

Perform the following step when the power has been off:

Press and hold the [] button for more than 2 seconds and then release the [] button when "" appears on the display. The "" will blink to show that Bluetooth® is now turned on.

4.4 Restoring Your Monitor to the Default Settings

To delete all stored information, follow these instructions. Ensure the monitor is turned off (screen is not showing numbers or symbols).

1. While holding the [] button down, the Connection symbol "" and "P" appear on the display. Then press the [START/STOP] button for more than 5 seconds.
2. When the "Clear" symbol appears on the display, release the [] button and [START/STOP] button. The "Clear" message indicates that monitor settings have reverted to their original state.
3. Press the [START/STOP] button to turn the monitor off.

Notes on Restoring Settings:

• The monitor will automatically turn off after 2 minutes.
• Reverting to initial settings will not delete information in the app.
• When using the monitor again, first delete its registration in the app and then pair your monitor.

5. Error Messages and Troubleshooting

5.1 Error Messages

5.2 Troubleshooting

6. Maintenance, Storage and Cleaning

6.1 Maintenance

To protect your monitor from damage:

• Store the monitor and components in a clean, safe location.
• Do not wash the monitor or components or immerse them in water.
• Do not use gasoline, thinners, or similar solvents to clean the monitor.
• Changes or modifications not approved by the manufacturer will void the user warranty.
• Do not disassemble or attempt to repair the monitor or components.

6.2 Storage

Do not store the monitor in the following situations:

• If the monitor is wet.
• Locations exposed to extreme temperatures, humidity, direct sunlight, dust, or corrosive vapors (e.g., bleach).
• Locations exposed to vibrations, shocks, or where it will be at an angle.

6.3 Cleaning

• Do not use abrasive or volatile cleaners.
• Use a soft dry cloth, or a soft cloth moistened with neutral soap to clean the monitor and arm cuff, then wipe with a dry cloth.

7. Disposal

Dispose of the monitor and components according to applicable local regulations. Unlawful disposal may cause environmental pollution.

8. Specifications

Notes:

• These specifications are subject to change without notice.
• In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood pressure.
• This monitor is clinically investigated according to the requirements of ISO 81060-2:2013.
• This monitor has not been validated for use on pregnant patients.
• IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This device is protected against solid foreign objects of 12 mm diameter and greater such as a finger, and against oblique falling water drops which may cause issues during a normal operation.

About a wireless communication interference

This Product operates in the unlicensed ISM band at 2.4GHz. If used around other wireless devices (microwave, wireless LAN) operating on the same frequency band, interference may occur. If such interference occurs, stop the operation of other devices, relocate this Product, or do not use this Product around other wireless devices.

Pictogram on the Product

The following pictograms ( or ) are used to indicate the correct positioning of the artery for the upper arm.

9. FCC Statement

FCC CAUTION

Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines. This equipment has very low levels of RF energy that are deemed to comply without testing of specific absorption ratio (SAR).

10. Limited Warranty

Your BP7000 Upper Arm Blood Pressure Monitor, excluding batteries, is warranted to be free from defects in materials and workmanship appearing within 5 years from the date of purchase, when used in accordance with the instructions provided with the monitor. The warranty extends only to the original retail purchaser and only to products purchased from an Omron authorized seller. Omron will, at its option, replace without charge any monitor covered by the warranty. Replacement is Omron's sole responsibility and your only remedy.

To obtain warranty service, contact Customer Service by calling 1-800-634-4350 for the address of the inspection center and return shipping and handling fee information. Enclose the original printed receipt. Include a letter with your name, address, phone number, and a description of the specific problem. Pack the product carefully to prevent damage in transit. Because of possible loss in transit, we recommend insuring the product with return receipt requested.

The foregoing is the sole warranty provided by OMRON in connection with this product. OMRON disclaims any other warranties, express or implied, including implied warranties of merchantability and fitness for a particular purpose. Implied warranties and other terms imposed by law, if any, are limited in duration to the period of the express warranty.

OMRON shall not be liable for loss of use or any other special, incidental, consequential or indirect costs, expenses or damages.

This warranty provides you with specific legal rights, and you may have other rights that vary by jurisdiction. Because of special local requirements, some of the above limitations and exclusions may not apply to you.

For Customer Service:

Visit our web site at: OmronHealthcare.com

Call toll free: 1-800-634-4350

11. Guidance and Manufacturer's Declaration

OMRON Blood Pressure Monitor (BPM)

Information for accompanying documents in the scope of IEC60601-1-2:2007

Important information regarding Electromagnetic Compatibility (EMC)

With the increased number of electronic devices such as PCs and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation. Medical devices should also not interfere with other devices.

In order to regulate the requirements for EMC (Electromagnetic Compatibility) with the aim to prevent unsafe product situations, the IEC60601-1-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices. Medical devices manufactured by OMRON Healthcare conform to this IEC60601-1-2:2007 standard for both immunity and emissions.

Nevertheless, special precautions need to be observed:

• The use of accessories and cables other than those specified by OMRON, with the exception of cables sold by OMRON as replacement parts for internal components, may result in increased emission or decreased immunity of the device.
• The medical devices should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the medical device should be observed to verify normal operation in the configuration in which it will be used.
• Refer to further guidance below regarding the EMC environment in which the device should be used.
• The MEDICAL ELECTRICAL EQUIPMENT BPM needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this documentations.
• The Essential Performance of the BPM is to measure a blood pressure and a pulse rate and using the memory function.

The BPM may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSION requirements.

Guidance and manufacturer's declaration - electromagnetic emissions

OMRON battery-operated BPM is intended for use in the electromagnetic environment specified below. The customer or the user of this OMRON battery-operated BPM should assure that it is used in such environment.

Guidance and manufacturer's declaration - electromagnetic immunity

OMRON battery-operated BPM is intended for use in the electromagnetic environment specified below. The customer or the user of this OMRON battery-operated BPM should assure that it is used in such environment.

Note: UT is the A.C. mains voltage prior to application of the test level.

Guidance and manufacturer's declaration - electromagnetic immunity

OMRON battery-operated BPM is intended for use in the electromagnetic environment specified below. The customer or the user of this OMRON battery-operated BPM should assure that it is used in such environment.

Note1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

^a Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the OMRON battery-operated BPM is used exceeds the applicable RF compliance level above, the OMRON battery-operated BPM should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the OMRON battery-operated BPM.

^b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 6 V/m.

Recommended separation distance between portable and mobile RF communications equipment and the OMRON battery-operated BPM

OMRON battery-operated BPM is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this OMRON battery-operated BPM can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the OMRON battery-operated BPM as recommended below, according to the maximum output power of the communications equipment.

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.