X7 Smart - Blood pressure monitor OMRON - Free user manual and instructions

USER MANUAL X7 Smart OMRON

Thank you for purchasing the OMRON Automatic Upper Arm 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.

1.1 Safety Instructions

This instruction manual provides you with important information about the OMRON Automatic Upper Arm Blood Pressure Monitor. To ensure the safe and proper use of this monitor, READ and UNDERSTAND all of the safety and operating instructions. If you do not understand these instructions or have any questions, contact your OMRON retail outlet or distributor before attempting to use this monitor. For specific information about your own blood pressure, consult with your physician.

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. It is mainly designed for general household use. The device can detect an irregular pulse suggestive of Atrial Fibrillation

(Afib). Please note that the device is not intended to diagnose Afib. A diagnosis of Afib can only be confirmed by Electrocardiogram (ECG). If the Afib symbol appears, consult your physician.

1.3 Receiving and Inspection

Remove this monitor and other components from the packaging and inspect for damage. If this monitor or any other components is damaged, DO NOT USE and consult with your OMRON retail outlet or distributor.

2. Important Safety Information

Read the Important Safety Information in this instruction manual before using this monitor. Follow this instruction manual thoroughly for your safety. Keep for future reference. For specific information about your own blood pressure, CONSULT WITH YOUR PHYSICIAN.

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

• DO NOT use this monitor on infants, toddlers, children or persons who cannot express themselves.

• DO NOT adjust medication based on readings from this blood pressure monitor. Take medication as prescribed by your physician. ONLY a physician is qualified to diagnose and treat high blood pressure and Afib.

• DO NOT use this monitor 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 this monitor in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, computerized tomography (CT) scanners. This may result in incorrect operation of the monitor and/or cause an inaccurate reading.

• DO NOT use this monitor in oxygen rich environments or near flammable gas.

• Consult with 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.

• NEVER diagnose or treat yourself based on your readings. ALWAYS consult with your physician.

• To help avoid strangulation, keep the air tube and AC adapter cable away from infants, toddlers and children.

• 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 this product in locations where RF is restricted, such as on an aircraft or in hospitals. Turn off the Bluetooth® feature in this monitor, 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 the AC adapter cable is damaged. If this monitor or the 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.

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 with your physician if you experience skin irritation or discomfort.

• Consult with your physician before using this monitor on an arm where intravascular access or therapy, or an arteriovenous (A-V) shunt, is present because of temporary interference to blood flow and could result in injury.

• Consult with your physician before using this monitor if you have had a mastectomy. ENEN2

• Consult with 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 because bruising, due to blood flow interference, may occur.

• 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.

• DO NOT use this monitor for any purpose other than measuring blood pressure and/or detecting the possibility of Afib.

• During measurement, make sure that no mobile device or any other electrical device that emit electromagnetic fields is within 30 cm of this monitor. This may result in incorrect operation of the monitor and/or cause an inaccurate reading.

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

• DO NOT use in a location where there is moisture or a risk of water splashing this monitor. This may damage this monitor.

• DO NOT use this monitor in a moving vehicle such as in a car or on 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 6.

• During measurement, observe the arm to ensure that 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. This may result in incorrect operation and/or cause an 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 that this 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 for approximately 2 hours for the monitor to warm up or cool down when the monitor is used in an environment within the temperature specified as operating conditions after it is stored either at the maximum or at the minimum storage temperature. For additional information on operating and storage / transport temperature, refer to section 6.

• DO NOT use this monitor after the durable period has ended. Refer to section 6.

• DO NOT crease the arm cuff or the air tube excessively.

• DO NOT fold or kink the air tube while taking a measurement. This may cause an 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 AC adapters, arm cuffs and batteries may damage and/or may 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. NOTE: refer to “If your systolic pressure is more than 210mmHg” in section 13 of instruction manual for additional information.

• Read and follow the “Correct Disposal of This Product” in section 7 when disposing of the device and any used accessories or optional parts. Data Transmission

• DO NOT replace batteries or unplug the AC adapter while your readings are being transferred to your smart device. This may result in incorrect operation of this monitor 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 from the outlet, be sure to safely pull from the AC adapter. DO NOT pull from the AC adapter cable.

• When handling the AC adapter cable: Do not damage it. / Do not break it. / Do not tamper with it. / DO NOT pinch it. / Do not forcibly bend or pull it. / Do not twist it. / DO NOT use it if it is gathered in a bundle. / DO NOT place it 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 with this monitor. 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 should get in your eyes, immediately rinse with plenty of clean water. Consult with your physician immediately.EN3

• 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 with your physician.

• DO NOT use batteries after their expiration date.

• Periodically check batteries to ensure they are in good working condition.

2.3 General Precautions

• To stop a measurement, press the [START/STOP] button while taking a measurement.

• When you take 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 the values between both arms differ substantially, check with your physician on which arm to use for your measurements.

• When using an optional AC adapter, make sure not to place your monitor in a location where it is difficult to plug and unplug the AC adapter. 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.EN4

If any of the below problems occur during measurement, check to make sure that no other electrical device is within 30 cm. If the problem persists, please refer to the table below. Display/Problem Possible Cause Solution appears or the arm cuff does not inflate. The [START/STOP] button was pressed while the arm cuff is not applied. Press the [START/STOP] button again to turn the monitor off. After inserting the air plug securely and applying the arm cuff correctly, press the [START/STOP] button. Air plug is not completely plugged into the monitor. Insert the air plug securely. The arm cuff is not applied correctly. Apply the arm cuff correctly, then take another measurement. Refer to section 7 of instruction manual

Air is leaking from the arm cuff. Replace the arm cuff to the new one. Refer to section 14 of instruction manual

appears or a measurement cannot be completed after the arm cuff inflates. You move or talk during a measurement and the arm cuff does not inflate sufficiently. Remain still and do not talk during a measurement. If “E2” appears repeatedly, inflate the arm cuff manually until the systolic pressure is 30 to 40mmHg above your previous readings. Refer to section 13 of instruction manual

Due to the systolic pressure is above 210mmHg, a measurement cannot be taken. appears The arm cuff is inflated exceeding the maximum allowable pressure. Do not touch the arm cuff and/or bend the air tube while taking a measurement. If inflating the arm cuff manually, refer to section 13 of instruction manual

appears You move or talk during a measurement. Vibrations disrupt a measurement. Remain still and do not talk during a measurement. appears The pulse rate is not detected correctly. Apply the arm cuff correctly, then take another measurement. Refer to section 7 of instruction manual . Remain still and sit correctly during a measurement. If the “ ” symbol continues to appear, we recommend you to consult with your physician.

appears does not flash during a measurementEN5 Display/Problem Possible Cause Solution appears Blood pressure measurements were not taken correctly in an Afib mode measurement. Apply the arm cuff correctly, then take another measurement. Refer to section 7 of instruction manual . Remain still and sit correctly during a measurement. Refer to section 8 of instruction manual

appears The monitor has malfunctioned. Press the [START/STOP] button again. If “Er” still appears, contact your OMRON retail outlet or distributor. appears The monitor cannot connect to a smart device or transmit data correctly. Follow the instructions shown in the “OMRON connect” app. If the “Err” symbol still appears after checking the app, contact your OMRON retail outlet or distributor. flashes The monitor is waiting for pairing with the smart device. Refer to section 5 of instruction manual for pairing your monitor with your smart device, or press [START/STOP] button to cancel pairing and turn your monitor off. flashes The monitor is ready to transfer your readings to the smart device. Open the “OMRON connect” app to transfer your readings. flashes More than 80 readings are not transferred. Pair or transfer your readings to the “OMRON connect” app so you can keep them in memory in the app, and this error symbol disappears. The date and time is not set. appears 100 readings are not transferred. flashes Batteries are low. Replacing all 4 batteries with new ones is recommended. Refer to section 4 of instruction manual

appears or the monitor is turned off unexpectedly during a measurement Batteries are depleted. Immediately replace all 4 batteries with new ones. Refer to

section 4 of instruction manual

Nothing appears on the display of the monitor. Battery polarities are not properly aligned. Check the battery installation for proper placement. Refer to

section 4 of instruction manual

Readings appear too high or too low. Blood pressure varies constantly. Many factors including stress, time of day, and/or how you apply the arm cuff, may affect your blood pressure. Review section 2 of instruction manual

Any other communication issue occurs. Follow the instructions shown in the smart device, or visit the “Help” section in the “OMRON connect” app for further help. If the problem still persists, contact your OMRON retail outlet or distributor.EN6

Display/Problem Possible Cause Solution Any other problem occurs. Press the [START/STOP] button to turn the monitor off, then press it again to take a measurement. If the problem continues, remove all batteries and wait for 30 seconds. Then re-install batteries. If the problem still persists, contact your OMRON retail outlet or distributor. 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 11 for details. If the “ ” symbol does not appear, it means there is no possibility of Afib? Even if the “ ” symbol does not appear, there is still a possibility of Afib. Should I consult with my physician if the “ ” symbol appears? We recommend you to consult with your physician because there is a possibility of Afib. However, the “

symbol may be displayed for other reasons, such as other heart arrhythmias. What is different between Afib indicator function and irregular heart beat 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 “

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

” 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 “

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.

• Prof. Roland Asmar et al. European Society of Hypertension Recommendations for Conventional, Ambulatory and Home Blood Pressure MeasurementEN7

Thank you for buying an OMRON product. This product is constructed of high quality materials and great care has been taken in its manufacturing. It is designed to give you every satisfaction, provided that it is properly operated and maintained as described in the instruction manual. This product is warranted by OMRON for a period of 3 years after the date of purchase. The proper construction, workmanship and materials of this product is warranted by OMRON. During this period of warranty OMRON will, without charge for labour or parts, repair or replace the defect product or any defective parts. The warranty does not cover any of the following: A. Transport costs and risks of transport. B. Costs for repairs and / or defects resulting from repairs done by unauthorised persons. C. Periodic check-ups and maintenance. D. Failure or wear of optional parts or other attachments other than the main device itself, unless explicitly warranted above. E. Costs arising due to non-acceptance of a claim (those will be charged for). F. Damages of any kind including personal caused accidentally or from misuse. G. Calibration service is not included within the warranty. H. Optional parts have a one (1) year warranty from date of purchase. Optional parts include, but are not limited to the following items: cuff and cuff tube. Should warranty service be required please apply to the dealer whom the product was purchased from or an authorised OMRON distributor. For the address refer to the product packaging / literature or to your specialised retailer. If you have difficulties in finding OMRON customer services, contact us for information: www.omron-healthcare.com Repair or replacement under the warranty does not give rise to any extension or renewal of the warranty period. The warranty will be granted only if the complete product is returned together with the original invoice / cash ticket issued to the consumer by the retailer.

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.

• 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 your monitor and other components 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.

• To protect your monitor during storage, an optional LCD cover is available as accessory. Refer to section 15 of Instruction Manual

• 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.

5.4 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 authorised OMRON dealer or the OMRON Customer Service at the address given on the packaging or attached literature.EN8

Product Category Electronic Sphygmomanometers Product description Automatic Upper Arm Blood Pressure Monitor Model (Code) M7 Intelli IT (HEM-7361T-EBK) / X7 Smart (HEM-7361T-ESL) Display LCD digital display Cuff pressure range 0 to 299mmHg Blood pressure measurement range SYS: 60 to 260mmHg DIA: 40 to 215mmHg Pulse measurement range 40 to 180 beats / min. Accuracy Pressure: ±3mmHg Pulse: ±5% of display reading Inflation Automatic by electric pump Deflation Automatic pressure release valve Measurement method Oscillometric method Transmission method Bluetooth

Low Energy Wireless communication Frequency range: 2.4GHz (2400 - 2483.5 MHz) / Modulation: GFSK Effective radiated power: <20dBm Operation mode Continuous operation IP classification Monitor: IP20 Optional AC adapter: IP21 (HHP-CM01) or IP22 (HHP-BFH01) Rating DC6V 4.0W Power source 4 “AA” batteries 1.5 V or optional AC adapter (INPUT AC 100 - 240V 50/60Hz 0.12 - 0.065A) Battery life Approximately 1000 measurements (using new alkaline batteries) The number of times may decrease when using Afib mode because one Afib indication consists of 3 regular measurements. Durable period (Service life) Monitor: 5 years / Cuff: 5 years / Optional AC adapter: 5 years Operating conditions +10 to +40°C / 15 to 90% RH (non-condensing) / 800 to 1060hPa Storage / Transport conditions -20 to +60°C / 10 to 90% RH (non-condensing) Weight Monitor: approximately 460g (notincluding batteries) Arm cuff: approximately 163g Dimensions (approximately value) Monitor: 191mm (W) × 85mm (H) × 120mm (L) / Arm cuff:145mm × 532mm (air tube: 750mm) Cuff circumference applicable to the monitor 220 to420 mm Memory Stores up to 100 readings per user Contents Monitor, arm cuff (HEM-FL31), 4 “AA” batteries, Instruction Manual and , setup instructions, storage case Protection against electric shock Internally powered ME equipment (When using only batteries) Class II ME equipment (Optional AC adapter) Applied part Type BF (arm cuff) Note

• These specifications are subject to change without notice.

• This monitor is clinically investigated according to the requirements of ISO81060-2:2013. In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood pressure.EN9

• This device has been validated for use on pregnant and pre-eclampsia patients according to the Modified European Society of Hypertension Protocol*.

• This device has been validated for use on diabetic (TypeII) population**.

• IP classification is degrees of protection provided by enclosures in accordance with IEC60529. This monitor and optional AC adapter are protected against solid foreign objects of 12.5mm diameter and greater such as a finger. The optional AC adapter HHP-CM01 is protected against vertically falling water drops which may cause issues during a normal operation. The optional AC adapter HHP-BFH01 is protected against oblique falling water drops which may cause issues during a normal operation.

• Topouchian J et al. Vascular Health and Risk Management 2018:14 189–197 ** Chahine M.N. et al. Medical Devices: Evidence and Research 2018:11 11–20 About a wireless communication interference This product operates in an unlicensed ISM band at 2.4GHz. 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.

7. 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.

8. Important Information regarding

Electromagnetic Compatibility (EMC) HEM-7361T-EBK/ESL conforms to the EN60601-1-2:2015 Electromagnetic Compatibility (EMC) standard. Further documentation in accordance with this EMC standard is available at OMRON HEALTHCARE EUROPE at the address mentioned in this instruction manual or at: www.omron-healthcare.com.

9. Guidance and Manufacturer’s Declaration

• This blood pressure monitor is designed according to the European Standard EN1060, 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 equipments type HEM-7361T-EBK/ESL is in compliance with Directive 2014/53/EU.

• The full text of the EU declaration of conformity is available at the following internet address: www.omron-healthcare.com

• 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.

10. 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 10minute 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 10minute timeframe in the evening between 19:00 - 1:59 will be used to calculate the evening average for each day. Within 10 min. Measurements in the morning Measurements in the evening Within 10 min.EN10

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 a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart- related complications. 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. 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 2018FR1

• Prof. Roland Asmar et al. European Society of Hypertension Recommendations for Conventional, Ambulatory and Home Blood Pressure MeasurementIT7

• Prof. Roland Asmar et al. European Society of Hypertension Recommendations for Conventional, Ambulatory and Home Blood Pressure MeasurementES7

• Prof. Roland Asmar et al. European Society of Hypertension Recommendations for Conventional, Ambulatory and Home Blood Pressure MeasurementNL7

Applied part - Type BF Degree of protection against electric shock (leakage current)

Δϳ΋ΎΑέϬϛϟ΍ΕΎϣΩλϟ΍SD2 Indicates the manufacturer’s catalogue number

Manufacturer’s quality control mark

Kol çevres Necessity for the user to consult this instruction manual

Δόϧλϣϟ΍ΔϛέηϟΎΑSD4 Need for the user to follow this instruction manual thoroughly for your safety.

ϊϳϧλΗϟ΍ΦϳέΎΗ ARSD5 To indicate generally elevated, potentially hazardous, levels of non-ionizing radiation, or to indicate equipment or systems. e.g. in the medical electrical area that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment.

ϰϠϋΔϳϭΗΣϣϟ΍ϥϛΎϣϷ΍ϲϓΓΩϭΟϭϣϟ΍ϝΛϣˬΔϣυϧϷ΍ϭ΃ΓίϬΟϷ΍ϰϟ·ΓέΎηϺϟϭ΃ˬΓέρΧ ϡΗϳΙϳΣϭ΃ΔϳϛϠγϻΕ΍ΩΩέΗΎϬϧϣΙόΑϧΗϝΎγέ·ΓίϬΟ΃ϰϠϋϝϣΗηΗΔϳΑρΔϳ΋ΎΑέϬϛΓίϬΟ΃ ιϳΧηΗϟ΍ν΍έϏϷΩϣϋϥϋΔϳϛϠγϼϟ΍Ε΍ΩΩέΗϟ΍Ε΍ΫΔϳγϳρΎϧϐϣϭέϬϛϟ΍ΔϗΎρϟ΍ϡ΍ΩΧΗγ΍ Νϼόϟ΍ϭ΃SD6 The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by OMRON HEALTHCARE Co., Ltd. is under license. Other trademarks and trade names are those of their respective owners. App Store is a service mark of Apple Inc., registered in the U.S and other countries. Google Play and the Google Play logo are trademarks of Google LLC..

Read Instruction manual and before use.

Downloading the "OMRON connect" App.....5

Setting Date and Time Manually....................8

Optional Medical Accessories........................29

Preparing for a Measurement

5 minutes before: Relax and rest.

Downloading the "OMRON connect" App

Follow the instructions.

The date and time will automatically be set when your monitor is paired with the app.

Setting Date and Time Manually

If your monitor is paired with your smart device, date and time is set automatically. When you need to set them manually, set year > month > day > hour > minute.

Applying the Cuff on the Left Arm

Tube side of the cuff should be 1 - 2cm above the inside elbow.

Make sure that air tube is on the inside of your arm and wrap the cuff securely so it can no longer slip round.

If taking measurements on the right arm, refer to:

Sit comfortably with your back and arm supported.

Place the arm cuff at the same level as your heart.

Keep feet flat, legs uncrossed, remain still and do not talk.

Selecting User ID (1 or 2)

Switching user ID enables you to save readings for 2 people.

Taking a Measurement

When the [START/STOP] button is pressed, the measurement is taken and saved automatically. Open the app to transfer the reading.

In the Afib mode, your monitor automatically takes 3 consecutive readings at 30-second intervals and displays the average. If there is a possibility of atrial fibrillation (Afib), “Afib indicator symbol” ( ) will appear. This is not a diagnosis, it is only a potential finding for Afib. You should contact your physician to discuss the findings. If you are experiencing any symptoms, contact a medical professional.

Instruction Manual P.1817 Taking a measurement in guest mode

The guest mode can be used to take a single measurement for another user. No readings are stored in the memory, and the Afib mode is not available when the guest mode is selected.

Checking Readings in Comparison Mode

Appears if a possibility of Afib* was detected during the Afib mode measurement. If it continues to appear, we recommend you to consult with and follow the directions of your physician.

Appears if "SYS" is 135mmHg or above and/or "DIA" is 85mmHg** or above.

Cuff is tight enough.

Appears when your body moves during a measurement. Remove the arm cuff, wait 2-3minutes and try again. (The body movement function is disabled when the possibility of Afib or irregular heartbeat is detected during a Afib mode measurement.)

Appears when an irregular rhythm* is detected during a measurement. If it continues to appear, it is recommended to consult your physician. (It does not appear during a Afib mode measurement)

• Afib and an irregular heartbeat rhythm are defined as a rhythm that is 25% less or 25% more than the average rhythm detected while your monitor is measuring blood pressure. The difference between the Afib indicator function and irregular heartbeat function is: Afib indicator function: detects Afib possibility in 3-times measurement. Irregular heartbeat function: detects irregular heartbeat including Afib in 1 measurement.

** The high blood pressure definition is based on the 2018 ESH/ESC Guidelines.

Before using memory functions, select your user ID.

12.1 Readings Stored in Memory

Stores up to 100 readings.

Appears if "SYS" is 135mmHg or above and/or "DIA" is 85mmHg or above in the morning weekly average. wk ago wks ago wks ago wks ago

To know how to calculate weekly averages, refer to section10 of the Instruction Manual .

12.3 Average of the Latest 2 or 3 Readings Taken within a

12.4 Deleting All Readings for 1 User

10 sec+ 3 sec+ Bluetooth is enabled by default.

13.2 Restoring to the Default Settings

Δϳο΍έΗϓϻ΍Ε΍Ω΍ΩϋϹ΍ΓΩΎόΗγ΍28 If your systolic pressure is more than 210mmHg: After the arm cuff starts to inflate, press and hold the [START/STOP] button until the monitor inflates 30 to 40mmHg higher than your expected systolic pressure.

Optional Medical Accessories

Do not throw the air plug away. The air plug can be applicable to the optional cuff.

IM2-HEM-7361T-E-04-01/2020