OMRON M3 (HEM-7154-E) Automatic Upper Arm Blood Pressure Monitor

Introduction

Thank you for purchasing an OMRON Automatic Upper Arm Blood Pressure Monitor. This monitor uses the oscillometric method of blood pressure measurement. This means that the unit detects your blood's movement through your brachial artery and converts these movements into a digital reading. It is compact, easy to use and features an Intellisense™ technology for comfortable, controlled inflation. This monitor is intended for home use.

Safety Instructions

This instruction manual contains important information for the safe and proper use of your OMRON Automatic Upper Arm Blood Pressure Monitor. Please read this manual carefully before using the device. If you have any questions, contact your retailer or OMRON distributor. Consult your physician regarding your specific blood pressure values.

⚠️ Precaution! This symbol indicates a potentially hazardous situation which, if not avoided, may result in death or serious injury.

• Do not use this device for infants, small children, or persons who cannot express their consent.
• Do not self-medicate based on the measurement results. Always follow the prescription of your physician. Only a qualified physician can diagnose and treat hypertension.
• Do not use this device on an arm that has an injury or is undergoing medical treatment (e.g., IV drip, blood transfusion).
• Do not apply the cuff over clothing or if your sleeve is rolled down.
• Do not use this device near high-frequency (HF) surgical equipment, Magnetic Resonance Imaging (MRI) equipment, or Computed Tomography (CT) scanners. This may cause the monitor to malfunction or lead to inaccurate measurements.
• Do not use this device in an oxygen-enriched environment or near flammable gases.
• Consult your physician before using this device if you have frequent arrhythmias (e.g., atrial or ventricular premature beats, atrial fibrillation), arteriosclerosis, poor perfusion, diabetes, pregnancy, pre-eclampsia, or kidney disease. Be aware that any of these conditions, as well as patient movement, tremors, or shivering, may affect the measurement.
• Never self-diagnose or self-treat based on the results obtained. Always consult your physician.

⚠️ Warning! This symbol indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury, or damage to equipment or other property.

• Keep the air tube and AC adapter cord out of reach of infants and children to prevent suffocation.
• The product contains small parts that may present a choking hazard if swallowed by an infant or child.

Handling the AC Adapter (Optional Accessory) and its Use

• Do not use the AC adapter if the device or its cord is damaged. If damaged, unplug immediately and contact your OMRON distributor.
• Only plug the AC adapter into a socket with the correct voltage. Do not use a multi-outlet adapter.
• Never insert the AC adapter cord into a socket or remove it with wet hands.
• Never disassemble or attempt to repair the AC adapter.

Handling Batteries and Their Use

• Store batteries out of reach of children and infants.
• If you have serious circulatory problems or blood disorders, consult your physician before using the device, as inflating the cuff may cause bruising.
• Do not take measurements more often than necessary, as this may cause bruising due to impaired circulation.
• Inflate the cuff ONLY when it is wrapped around your arm.
• Remove the cuff if it does not start deflating during measurement.
• Do not use this device for any purpose other than measuring blood pressure.
• When measuring, ensure that no mobile devices or other electrical devices emitting electromagnetic fields are within 30 cm of the device. This may cause the monitor to malfunction or lead to inaccurate measurements.
• Do not disassemble this device or any of its components, and do not attempt to repair them. Doing so may result in inaccurate readings.
• Do not use in places with high humidity or where the device may be exposed to water splashes. This may damage the device.
• Do not use this device in a moving vehicle (e.g., car or airplane).
• Do not drop the device or subject it to strong shocks or vibrations.
• Do not use this device in environments with high or low humidity or at extreme temperatures. Refer to Section 6.
• During measurement, ensure that the cuff on the arm does not restrict blood flow for an extended period.
• Do not use this device in an environment with intensive use of equipment (e.g., clinic or doctor's office).
• Do not use this device simultaneously with other medical electrical equipment (ME equipment). This may cause malfunction or inaccurate results.
• Do not take a bath, drink alcohol or coffee, smoke, engage in strenuous exercise, or eat for at least 30 minutes before measurement.
• Rest for at least 5 minutes before taking a measurement.

General Precautions

• Before measurement, remove tight-fitting clothing or roll up your sleeve tightly.
• Do not move or talk during measurement.
• Use the cuff ONLY for patients whose arm circumference falls within the specified range for the cuff.
• Ensure the device is at room temperature before measurement. Measuring after a sudden temperature change may result in inaccurate readings. If the device has been stored at extreme temperatures, allow it to acclimate to room temperature for approximately 2 hours before use. Refer to Section 6 for operating and storage/transport temperature conditions.
• Do not use this device beyond its service life. Refer to Section 6.
• Do not excessively bend the cuff and air tube.
• When measuring, do not kink or twist the air tube. This may cause injury due to restricted blood flow.
• When disconnecting the air plug, pull the plastic air plug at the base of the tube, not the tube itself.
• Use ONLY the AC adapter, cuff, batteries, and accessories specified for this device. Using other AC adapters, cuffs, or batteries may cause damage and/or malfunction of the device.
• Use ONLY the cuff designed for this device. Using other cuffs may result in inaccurate readings.
• Inflating the cuff with excessive pressure may cause bruising on the upper arm at the cuff site. NOTE: For more information, see "If your systolic pressure is higher than 210 mmHg" in Section 11 of the Instruction Manual (2).
• Read the "Proper Disposal of the Device (Waste Electrical and Electronic Equipment)" recommendations in Section 7 and follow them for disposal of the device and its accessories or spare parts.

Handling the AC Adapter (Optional Accessory) and its Use

• Insert the AC adapter plug fully into the socket.
• When disconnecting the AC adapter from the socket, pull only the adapter. Do not pull the cord.
• Regarding the AC adapter cord: Do not damage it, bend it, or twist it. Do not pinch it. Do not place heavy objects on it.
• Remove dust from the AC adapter.
• If the AC adapter is not in use, unplug it from the socket.
• Unplug the AC adapter from the socket before cleaning the device.

Handling Batteries and Their Use

• Always observe the correct polarity when inserting batteries.
• Use only four AA alkaline or manganese batteries for this device. Do not use batteries of other types. Do not mix new and old batteries. Do not mix batteries of different brands.
• Remove batteries if the device is not expected to be used for an extended period.
• If battery electrolyte gets into your eyes, rinse immediately with plenty of clean water. Seek immediate medical attention.
• If battery electrolyte gets onto your skin, rinse the affected area with plenty of lukewarm water. If irritation, injury, or pain persists, seek medical attention.
• Do not use batteries after their expiration date.
• Periodically check the batteries to ensure they are functioning.

Troubleshooting

If you encounter problems during measurement as indicated below, ensure no other electrical devices are within 30 cm of the device. If the problem persists, refer to the table below.

Limited Warranty

Thank you for purchasing an OMRON product. This device is manufactured with high-quality materials and is built to last with proper care. It is designed to meet your needs when operated and maintained according to the instruction manual.

OMRON provides a 5-year limited warranty on this product from the date of purchase. OMRON warrants the product against defects in construction, materials, and workmanship. During the warranty period, OMRON will, at its option, repair or replace any defective unit or part free of charge for labor or parts.

The warranty does not cover:

• A. Costs and risks associated with transportation.
• B. Costs of repair and/or defects related to repairs performed by unauthorized personnel.
• C. Routine checks and maintenance.
• D. Defects or wear of spare parts or accessories other than the main unit, unless expressly stated in the warranty.
• E. Costs associated with claim rejection (charges will apply).
• F. Compensation for any damages, including personal damages, resulting from misuse of the product.
• G. Warranty does not cover calibration services.
• H. Warranty on accessories is one (1) year from the date of purchase. Accessories include the cuff and tubing.

For warranty service, please contact the retailer where you purchased the product or an authorized OMRON distributor. The address is indicated on the product packaging or documentation, or can be obtained from your local retailer. If you have difficulty locating an OMRON customer service center, please contact us at: www.omron-healthcare.com

Warranty repair or replacement of the product does not extend or renew the warranty period.

The warranty is valid only upon return of the product in its complete packaging along with the original invoice/receipt issued by the retail seller.

Technical Service

5.1 Maintenance

Follow these instructions to protect the device from damage. Any modification or alteration to the device not approved by the manufacturer will void the warranty.

⚠️ Warning! Do not disassemble this device or any of its components, and do not attempt to repair them. Doing so may result in inaccurate readings.

5.2 Storage

• When the device is not in use, store it in its case.
• 1. Detach the cuff from the device.

⚠️ Warning! When disconnecting the air plug, pull the plastic air plug at the base of the tube, not the tube itself.

• 2. Carefully fold the air tube inside the cuff. Note: Do not kink or crush the air tube excessively.
• 3. Place the device and its components in the storage case.
• Store the device and its components in a clean and safe place.
• Do not store the device and its components under the following conditions:
• If the device and its components are wet.
• If the storage location is exposed to high temperatures, humidity, direct sunlight, dust, or corrosive vapors (e.g., disinfectant solution).
• In locations subject to vibration or shock.

5.3 Cleaning

• Do not use abrasive or volatile cleaning agents.
• Clean the device and cuff with a soft, dry cloth or a soft cloth dampened with a mild (neutral) detergent, then wipe dry.
• Do not wet the device, cuff, or other components, and do not immerse them in water.
• Do not use gasoline, thinners, or similar solvents to clean the device, cuff, or other components.

5.4 Calibration and Maintenance

The accuracy of this blood pressure monitor has been carefully checked and is designed to remain accurate over a long period. It is recommended to check the measurement accuracy and proper functioning of the device every two years. Please contact an authorized OMRON representative or the OMRON Customer Service Center at the address indicated on the packaging or in the accompanying documentation.

6. Technical Specifications

Note: Technical specifications are subject to change without prior notice. This device has undergone clinical testing in accordance with EN ISO 81060-2:2014 and meets EN ISO 81060-2:2014 and EN ISO 81060-2:2019 + A1:2020. The K5 clinical validation study for diastolic blood pressure was performed on 85 subjects. The enclosure protection class classification conforms to IEC 60529. This device and the AC adapter are protected against ingress of solid foreign objects 12.5 mm in diameter or larger (e.g., finger). The AC adapter HHP-CM01 is protected against vertically falling water drops that could cause malfunctions during normal operation. The AC adapter HHP-BFH01 is protected against obliquely falling water drops that could cause malfunctions during normal operation.

7. Proper Disposal of the Device (Waste Electrical and Electronic Equipment)

This symbol on the product or its description indicates that the device should not be disposed of with other household waste at the end of its service life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate this item from other types of waste and recycle it responsibly to promote the sustainable reuse of material resources.

Household users should contact the retailer where they purchased this product or their local government office for details on 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 device should not be mixed with commercial waste for disposal.

8. Electromagnetic Compatibility (EMC) Information

The HEM-7154-E complies with the EMC standard EN60601-1-2:2015. Additional documentation regarding EMC compliance is available at www.omron-healthcare.com. See the EMC information for the HEM-7154-E on the website.

9. Manufacturer's Statements

• This blood pressure monitor is designed in accordance with the European standard EN1060 for non-invasive sphygmomanometers, Part 1: General Requirements and Part 3: Supplementary Requirements for Electromechanical Blood Pressure Measuring Systems.
• This OMRON product is manufactured under a strict quality control system by OMRON HEALTHCARE Co., Ltd., Japan. The pressure sensor, a key component of OMRON blood pressure monitors, is manufactured in Japan.
• Report any serious incidents that occur with this device to the manufacturer and the competent authority of the Member State in which you are located.

Symbols Description

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

Class II equipment. Protection against electric shock

IP XX Ingress protection degree provided by IEC 60529

CE Marking

Product Identification

UKCA marking

Serial number

LOT number

Unique device identifier

Medical device

Environmental Limitations

Temperature limitation

Humidity limitation

Atmospheric pressure limitation

Indication of connector polarity

Usage and Environmental Information

For indoor use only

OMRON's trademarked technology for blood pressure measurement

Identifier of cuffs compatible for the device

Cuff positioning indicator for the left arm

Marker on the cuff to be positioned above the artery

Range pointer and brachial artery alignment position

Range indicator of arm circumferences to help selection of the correct cuff size

Manufacturer's quality control mark

Material and Safety Information

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

Manufacturing and Prohibited Actions

Date of manufacture

Prohibited action

Document Information

Issue Date: 2022-05-25

Model Number: IM1-HEM-7154-E-05-01/2022

Document Code: 2870428-8D

Quick Start Guide (Instruction Manual 2)

Preparing for a Measurement

30 minutes before: Avoid eating, drinking alcohol, smoking, strenuous exercise, and bathing. Rest.

5 minutes before: Relax and rest.

Package Contents

Monitor, Cuff, 4 AA Batteries, Storage Case, Instruction Manuals (1 & 2).

Installing Batteries

1. Open the battery cover.
2. Insert 4 AA batteries, observing polarity.
3. Close the battery cover.

Setting Date and Time

Press [START/STOP] to turn on the device. Use the YEAR, MONTH, DAY, HOUR, and MINUTE buttons to set the date and time. Press [START/STOP] to confirm.

Applying the Cuff on the Left Arm

1. Ensure the air tube is on the inside of your arm.
2. Wrap the cuff snugly around your upper arm, about 1-2 cm above the inner elbow. The cuff tube should be on the inside of your arm.
3. Secure the cuff so it is snug but not too tight.

Sitting Correctly

Sit comfortably with your back and arm supported. Keep your feet flat on the floor, legs uncrossed. Remain still and do not talk during measurement.

Selecting User ID

Press the User ID button (1 or 2) to select the user. This allows saving readings for two people.

Taking a Measurement

Press the [START/STOP] button. The cuff will inflate automatically. Remain still and do not talk during measurement. The measurement will be taken and saved automatically.

Checking Readings

High Blood Pressure Indicator: Appears if "SYS" is 135 mmHg or above and/or "DIA" is 85 mmHg* or above.

Irregular Heartbeat Indicator: Appears if an irregular rhythm is detected during measurement. If it appears repeatedly, consult your physician.

Body Movement Indicator: Appears if your body moves during measurement. Remove the cuff, wait 2-3 minutes, and try again.

Cuff Tightness: Ensure the cuff is applied correctly and is snug enough.

Using Memory Functions

Up to 60 readings can be stored for each user. Before using memory functions, select your user ID.

Viewing Readings: Access stored readings.

Average of Latest Readings: Displays the average of the last 2 or 3 readings taken within a 10-minute span.

Deleting All Readings: Clears all stored readings.

Other Settings

Restoring to Default Settings: Resets all settings to factory defaults.

High Systolic Pressure Procedure

If your systolic pressure is over 210 mmHg, after the cuff starts inflating, press and hold [START/STOP] until the monitor inflates 30-40 mmHg higher than your expected systolic pressure.

Optional Medical Accessories

Arm Cuff (HEM-RML31, HEM-CS24), AC Adapter (HHP-CM01, HHP-BFH01).

Note: Do not discard the air plug; it can be used with optional cuffs.

Manufacturer Information

Manufacturer: OMRON HEALTHCARE Co., Ltd., Japan

EU Representative: OMRON HEALTHCARE EUROPE B.V., The Netherlands

Production Facility: OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.

UK Importer and Responsible Person: OMRON HEALTHCARE UK LTD.

Website: www.omron-healthcare.com