OMRON Automatic Blood Pressure Monitor

Introduction

Thank you for purchasing the OMRON Automatic Blood Pressure Monitor. This blood pressure monitor uses the oscillometric method of blood pressure measurement. This means this monitor detects your blood movement through your brachial artery and converts the movements into a digital reading.

Safety Instructions

This instruction manual provides important information about the OMRON Automatic Blood Pressure Monitor. To ensure safe and proper use, READ and UNDERSTAND all safety and operating instructions. For questions, contact your local OMRON representative before use. Consult your physician for specific information about your blood pressure.

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

• DO NOT use on infants, toddlers, children, or persons who cannot express themselves.
• DO NOT adjust medication based on readings. Take medication as prescribed by your physician. Only a physician is qualified to diagnose and treat high blood pressure and Afib.
• DO NOT use on an injured arm or an arm under medical treatment.
• DO NOT apply the arm cuff on your arm while on an intravenous drip or blood transfusion.
• DO NOT use in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, computerized tomography (CT) scanners. This may result in incorrect operation or inaccurate reading.
• DO NOT use in oxygen rich environments or near flammable gas.
• Consult your physician if you have common arrhythmias, arterial sclerosis, poor perfusion, diabetes, pregnancy, pre-eclampsia, or renal disease. Patient motion, trembling, or shivering may affect the measurement reading.
• NEVER diagnose or treat yourself based on your readings. ALWAYS consult your physician.
• Keep the air tube and AC adapter cable away from infants, toddlers, and children to avoid strangulation.
• This product contains small parts that may cause a choking hazard if swallowed by infants, toddlers, and children.

Data Transmission

This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use in locations where RF is restricted, such as on an aircraft or in hospitals. Turn off the Bluetooth® feature, remove batteries, and/or unplug the AC adapter when in RF restricted areas.

AC Adapter (optional accessory) Handling and Usage

• DO NOT use the AC adapter if this monitor or cable is damaged. Turn off the power and unplug the AC adapter immediately.
• Plug the AC adapter into the appropriate voltage outlet. DO NOT use in a multi-outlet plug.
• NEVER plug in or unplug the AC adapter from the electric outlet with wet hands.
• DO NOT disassemble or attempt to repair the AC adapter.

Battery Handling and Usage

• Keep batteries out of the reach of infants, toddlers, and children.
• DO NOT insert batteries with their polarities incorrectly aligned.
• ONLY use 4 "AA" alkaline or manganese batteries. DO NOT use other types of batteries. DO NOT use new and used batteries together. DO NOT use different brands of batteries together.
• Remove batteries if this monitor will not be used for a long period of time.
• If battery fluid gets in your eyes, immediately rinse with plenty of clean water and consult your physician.
• If battery fluid gets on your skin, wash your skin immediately with plenty of clean, lukewarm water. If irritation, injury, or pain persists, consult your physician.
• DO NOT use batteries after their expiration date.
• Periodically check batteries to ensure they are in good working condition.

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

• 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 where intravascular access or therapy, or an arteriovenous (A-V) shunt, is present, due to temporary interference to blood flow and potential injury.
• Consult your physician before using this monitor if you have had a mastectomy.
• Consult your physician before using this 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 to prevent bruising due to blood flow interference.
• ONLY inflate the arm cuff when it is applied on your upper arm.
• Remove the arm cuff if it does not start deflating during a measurement.
• When the monitor malfunctions and gets hot, DO NOT touch the monitor.
• DO NOT use this monitor for any purpose other than measuring blood pressure and/or detecting the possibility of Afib.
• During measurement, ensure no mobile device or other electrical device emitting electromagnetic fields is within 30 cm of this monitor, as this may result in incorrect operation or inaccurate reading.
• DO NOT disassemble or attempt to repair this monitor or other components, as this may cause an inaccurate reading.
• DO NOT use in a location with moisture or risk of water splashing, as this may damage the monitor.
• DO NOT use this monitor in a moving vehicle such as a car or an aircraft.
• 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. Refer to section 5.
• During measurement, observe the arm to ensure the monitor is not causing prolonged impairment to blood circulation.
• DO NOT use this monitor in high-use environments such as medical clinics or physician offices.
• DO NOT use this monitor with other medical electrical (ME) equipment simultaneously, as this may result in incorrect operation and/or inaccurate reading.
• Avoid bathing, drinking alcohol or caffeine, smoking, exercising, and eating for at least 30 minutes before taking a measurement.
• Rest for at least 5 minutes before taking a measurement.
• Remove tight-fitting, thick clothing and any accessories from your arm while taking a measurement.
• Remain still and DO NOT talk while taking a measurement.
• ONLY use the arm cuff on persons whose arm circumference is within the specified range of the cuff.
• Ensure the monitor has acclimated to room temperature before taking a measurement. Taking a measurement after an extreme temperature change could lead to an inaccurate reading. OMRON recommends waiting approximately 2 hours for the monitor to warm up or cool down when used in an environment within the specified operating conditions after storage at the maximum or minimum storage temperature. Refer to section 5 for additional information on operating and storage/transport temperature.
• DO NOT use this monitor after the durable period has ended. Refer to section 5.
• DO NOT crease the arm cuff or the air tube excessively.
• DO NOT fold or kink the air tube while taking a measurement, as this may cause injury by interrupting blood flow.
• To unplug the air plug, pull on the plastic air plug at the base of the tube, not the tube itself.
• ONLY use the AC adapter, arm cuff, batteries, and accessories specified for this monitor. Use of unsupported items may damage or be hazardous to this monitor.
• ONLY use the approved arm cuff for this monitor. Use of other arm cuffs may result in incorrect readings.
• Inflating to a higher pressure than necessary may result in bruising of the arm where the cuff is applied. Refer to "If your systolic pressure is more than 210 mmHg" in section 13 of instruction manual 2 for additional information.
• Read and follow the "Correct Disposal of This Product" in section 6 when disposing of the device and any used accessories or optional parts.

Data Transmission

• DO NOT replace batteries or unplug the AC adapter while readings are being transferred to your smart device. This may result in incorrect operation and failure to transfer your blood pressure data.

AC Adapter (optional accessory) Handling and Usage

• Fully insert the AC adapter into the outlet.
• When unplugging the AC adapter, be sure to safely pull from the AC adapter, not the AC adapter cable.
• When handling the AC adapter cable: Do not damage, break, tamper with, pinch, forcibly bend or pull, twist, use if gathered in a bundle, or place under heavy objects.
• Wipe any dust off of the AC adapter.
• Unplug the AC adapter when not in use.
• Unplug the AC adapter before cleaning this monitor.

Battery Handling and Usage

• DO NOT insert batteries with their polarities incorrectly aligned.
• ONLY use 4 "AA" alkaline or manganese batteries. DO NOT use other types of batteries. DO NOT use new and used batteries together. DO NOT use different brands of batteries together.
• Remove batteries if this monitor will not be used for a long period of time.
• If battery fluid gets in your eyes, immediately rinse with plenty of clean water and consult your physician.
• If battery fluid gets on your skin, wash your skin immediately with plenty of clean, lukewarm water. If irritation, injury, or pain persists, consult your physician.
• DO NOT use batteries after their expiration date.
• Periodically check batteries to ensure they are in good working condition.

General Precautions

• When taking a measurement on the right arm, the air tube should be at the side of your elbow. Be careful not to rest your arm on the air tube.
• Blood pressure may differ between the right and left arm, and may result in a different measurement value. Always use the same arm for measurements. If values between both arms differ substantially, check with your physician on which arm to use.
• When using an optional AC adapter, make sure not to place your monitor where it is difficult to plug and unplug the AC adapter.
• To stop a measurement, press the [START/STOP] button while taking a measurement.

Battery Handling and Usage

• Disposal of used batteries should be carried out in accordance with local regulations.
• The supplied batteries may have a shorter life span than new batteries.

Error Messages and Troubleshooting

If problems occur during measurement, check that no other electrical device is within 30 cm. If the problem persists, refer to the table below.

Troubleshooting for Afib indicator function:

• What is different between the Afib indicator function and ECG?
  The Afib indicator function and ECG use completely different technologies. An ECG measures the electrical activity of the heart and can be used to diagnose Afib. The Afib indicator function detects irregular heartbeat and can suggest the possibility of Afib with a sensitivity of 95.5% and specificity of 93.8%. Refer to section 10 for details.
• If the [Afib symbol] symbol does not appear, it means there is no possibility of Afib?
  Even if the [Afib symbol] symbol does not appear, there is still a possibility of Afib.
• Should I consult with my physician if the [Afib symbol] symbol appears?
  We recommend you to consult with your physician because there is a possibility of Afib. However, the [Afib symbol] symbol may be displayed for other reasons, such as other heart arrhythmias.
• What is different between Afib indicator function and irregular heartbeat function?
  The irregular heartbeat function detects irregularities in the pulse waves in one measurement. The Afib indicator function suggests the possibility of Afib when blood pressure is measured 3 consecutive times.
• What should I do if the [Afib symbol] symbol sometimes appears?
  Afib does not always have symptoms. We recommend you to consult with and follow the directions of your physician.
• I have been diagnosed with Afib by the physician, but the [Afib symbol] symbol does not appear.
  Afib may not occur at the time of specific blood pressure measurements. We recommend you to consult with your physician regularly.
• Is the blood pressure reading reliable when the [Afib symbol] symbol appears?
  Afib or an irregular heartbeat can influence your blood pressure measurements and make it difficult to get an accurate reading. Repeated measurements may be required to overcome variabilities. In Afib mode, the blood pressure measurement is taken 3 times, and the average is displayed. The monitor will indicate an error message (E5/E6) if the influence of the irregular heartbeat is too severe to give a measurement result. If this occurs repeatedly, we recommend that you consult with your physician.

Maintenance

Maintenance

To protect your monitor from damage, follow the directions below:

Changes or modifications not approved by the manufacturer will void the user warranty.

Caution: DO NOT disassemble or attempt to repair this monitor or other components. This may cause an inaccurate reading.

Storage

• Keep your monitor in the storage case when not in use.
• 1. Remove the arm cuff from the monitor.
• Caution: To unplug the air plug, pull on the plastic air plug at the base of the tube, not the tube itself.
• 2. Gently fold the air tube into the arm cuff. Note: Do not bend or crease the air tube excessively.
• 3. Place your monitor and other components in the storage case.
• Store your monitor and other components in a clean, safe location.
• Do not store your monitor and other components:
  • If they are wet.
  • In locations exposed to extreme temperatures, humidity, direct sunlight, dust, or corrosive vapors such as bleach.
  • In locations exposed to vibrations or shocks.

Cleaning

• Do not use any abrasive or volatile cleaners.
• Use a soft dry cloth or a soft cloth moistened with mild (neutral) detergent to clean your monitor and arm cuff, and then wipe them with a dry cloth.
• Do not wash or immerse your monitor and arm cuff or other components in water.
• Do not use gasoline, thinners, or similar solvents to clean your monitor and arm cuff or other components.

Calibration and Service

The accuracy of this blood pressure monitor has been carefully tested and is designed for a long service life. It is generally recommended to have the unit inspected every two years to ensure correct functioning and accuracy. Please consult your authorized OMRON dealer or the OMRON Customer Service at the address given on the packaging or attached literature.

Specifications

Note

• These specifications are subject to change without notice.
• This monitor is clinically investigated according to the requirements of EN ISO 81060-2:2014 and complies with EN ISO 81060-2:2014 and EN ISO 81060-2:2019+A1:2020. In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood pressure.
• IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This monitor and optional AC adapter are protected against solid foreign objects of 12.5 mm diameter and greater such as a finger. The optional AC adapter (other than HHP-OH01 and HHP-BFH01) is protected against vertically falling water drops which may cause issues during a normal operation. HHP-OH01 and HHP-BFH01 are protected against oblique falling water drops which may cause issues during a normal operation.

About a wireless communication interference

This product operates in an unlicensed ISM band at 2.4 GHz. In the event this product is used near other wireless devices such as microwave and wireless LAN, which operate on the same frequency band as this product, there is a possibility that interference may occur. If interference occurs, stop the operation of the other devices or relocate this product away from other wireless devices before attempting to use it.

Correct Disposal of This Product (Waste Electrical & Electronic Equipment)

This marking shown on the product or its literature indicates that it should not be disposed of with other household wastes at the end of its working life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate this product from other types of wastes and recycle it responsibly to promote the sustainable reuse of material resources. Household users should contact either the retailer where they purchased this product, or their local government office, for details of where and how they can return this item for environmentally safe recycling. Business users should contact their supplier and check the terms and conditions of the purchase contract. This product should not be mixed with other commercial waste for disposal.

Important Information regarding Electromagnetic Compatibility (EMC)

This device conforms to the EN 60601-1-2:2015 Electromagnetic Compatibility (EMC) standard. Further documentation in accordance with this EMC standard is available at Asia Pacific: https://www.omronhealthcare-ap.com/emc-information Korea: https://www.omron-healthcare.co.kr/product/HEM-7361T Taiwan: https://www.omronhealthcare.com.tw/EMC

Guidance and Manufacturer's Declaration

This blood pressure monitor is designed according to the European Standard EN 1060, Non-invasive sphygmomanometers Part 1: General Requirements and Part 3: Supplementary requirements for electromechanical blood pressure measuring systems.

Hereby, OMRON HEALTHCARE Co., Ltd., declares that the radio equipment type HEM-7361T is in compliance with Directive 2014/53/EU. This OMRON product is produced under the strict quality system of OMRON HEALTHCARE Co., Ltd., Japan. The Core component for OMRON blood pressure monitors, which is the Pressure Sensor, is produced in Japan. Please report to the manufacturer and the competent authority of the Member State in which you are established about any serious incident that has occurred in relation to this device.

How to Calculate Weekly Averages

Morning Weekly Average Calculation

This is the average for the measurements taken during the morning (4:00 - 9:59) between Sunday and Saturday. The 2 or 3 readings taken within the first 10 minute timeframe in the morning between 4:00 - 9:59 will be used to calculate the morning average for each day.

Evening Weekly Average Calculation

This is the average for the measurements taken during the evening (19:00 - 1:59) between Sunday and Saturday. The 2 or 3 readings taken within the last 10 minute timeframe in the evening between 19:00 - 1:59 will be used to calculate the evening average for each day.

Morning Measurements: Within 10 min. (4:00 - 9:59)

Evening Measurements: Within 10 min. (19:00 - 1:59)

Useful Information

What is Blood Pressure?

Blood pressure is a measure of the force of blood flowing against the walls of the arteries. Arterial blood pressure is constantly changing during the course of the heart's cycle. The highest pressure in the cycle is called the Systolic Blood Pressure; the lowest is the Diastolic Blood Pressure. Both pressures, the Systolic and Diastolic, are necessary to enable a physician to evaluate the status of a patient's blood pressure.

What is Arrhythmia?

Arrhythmia is a condition where the heartbeat rhythm is abnormal due to flaws in the bio-electrical system that drives the heartbeat. Typical symptoms are skipped heartbeats, premature contraction, an abnormally rapid (tachycardia) or slow (bradycardia) pulse.

What is Afib?

Atrial fibrillation (also called Afib or AF) is an irregular pulse (arrhythmia) that can lead to stroke and heart failure. During atrial fibrillation, the heart's two upper chambers (the atria) beat chaotically and irregularly – out of coordination with the two lower chambers (the ventricles) of the heart. Episodes of atrial fibrillation can come and go, or you may develop atrial fibrillation that doesn't go away and may require treatment.

This device detects the possibility of Afib, so you can consult your physician for early diagnosis and treatment, which may prevent stroke or heart failure. Afib indicator function detects the possibility of Afib with an accuracy of 94.2% (with sensitivity of 95.5% and specificity of 93.8%) as demonstrated in the study* with Single-lead ECG as reference measurement.

*M. Ishizawa, T. Noma, T. Minamino et al., Multiple measurements with automated blood pressure monitor can detect atrial fibrillation with high sensitivity and specificity in general cardiac patients, ESC Congress 2018

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