Omron Hem-7361t Automatic Blood Pressure Monitor Instruction Manual

Automatic Blood Pressure Monitor
Instruction Manual

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 you with important information about the OMRON Automatic 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 local OMRON  representative before attempting to use this monitor. For specific information about your own blood pressure, consult with your physician.

Intended Use
This device is a digital monitor intended for use in measuring blood pressure and pulse rate in the adult patient population. The device detects the appearance of irregular heartbeats during measurement and indicates this via a symbol with the measurement result. 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.

Receiving and Inspection
Remove this monitor and other components from the packaging and inspect for damage. If this monitor or any other component is damaged, DO NOT USE and consult with your local OMRON representative.

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.

Warning
Indicates a potentially hazardous situation that, 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.

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 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.
• 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.
• When the monitor malfunctions, it may get hot. DO NOT touch the monitor if it occurs.
• 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 emits 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 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 5.
• 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 another 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 measurements.
• Remain still and DO NOT talk while taking 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 5.
• 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 measurements. 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 maybe 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 210 mmHg”  in section 13 of the instruction manual 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 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.
• 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.

General Precautions

• 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.
• To stop a measurement, press the [START/STOP] button while taking the 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 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. The air plug is not completely plugged into the monitor. The arm cuff is not applied correctly. Air is leaking from the arm cuff.	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. Insert the air plug securely. Apply the arm cuff correctly, then take another measurement. Refer to section 7 of instruction m annual 2. Replace the arm cuff with the new one. Refer to section 14 of instruction manual 2.
appears or measurement cannot be completed after the arm cuff inflates.	You move or talk during measurement and the arm cuff does not inflate sufficiently. Due to the systolic pressure is above 210 mmHg, a measurement cannot be taken.	Remain still and do not talk during measurement. If “E2” appears repeatedly, inflate the arm cuff manually until the systolic pressure is 30 to  40 mmHg above your previous readings. Refer to section 13 of instruction manual 2.
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 measurements. If inflating the arm cuff manually, refer to section 13 of  the instruction manual .
appears	You move or talk during measurement. Vibrations disrupt a measurement.	Remain still and do not talk during measurement.
appears	The pulse rate is not detected correctly.	Apply the arm cuff correctly, then take another measurement. Refer to section 7 of the 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 measurement
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 the instruction manual. Remain still and sit correctly during a measurement. Refer to section 8 of the instruction manual 2.
appears	The monitor has malfunctioned.	Press the [START/STOP] button again. If “Er” still appears, contact your local OMRON representative.
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 local OMRON representative.
flashes	The monitor is waiting for pairing with the smart device.	Refer to section 5 of instruction manual 2 for pairing your monitor with your smart device, or press the [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. The date and time is not set.	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.
appears	100 readings are not transferred.
flashes	Batteries are low.	Replacing all 4 batteries with new ones is recommended. Refer to section 4 of the instruction manual 2.
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 the instruction manual 2.
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 the 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 2.
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 local OMRON representative.
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 local OMRON representative.
Troubleshooting for Afib indicator function:
What is the difference 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 “  ” 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 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 the difference between the Afib indicator function and the 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 ”  ” Does 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 Measurement

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 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.

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 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 ISO 81060-2:2013. In the clinical validation study, K5 was used on 85 subjects for the 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 suppliers 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.

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 a 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 An automated blood pressure monitor can detect atrial fibrillation with high sensitivity and specificity in  general cardiac patients, ESC Congress 2018

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
	Serial number
	LOT number
	Medical device
	Indicates the manufacturer’s catalog number
	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
	Marker on the cuff to be positioned above the artery
LATEX-FREE	Not made with natural rubber latex
	Arm circumference
	Necessity 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
	Efficiency level of power supply
	SMPS (Switch mode power supply unit)
	SMPS incorporating a short-circuit-proof safety isolating transformer (inherently or non-inherently)
	KC mark
	BIS mark
	RCM compliance mark, which indicates compliance with electrical safety, EMC, EME & telecommunications requirements in Australia and New Zealand, as applicable to the product.
	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 includes RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment.

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 logo are trademarks of Google LLC.

2020-09-16
2895915-4D