OMRON M2 Basic (HEM-7121J-E) Instruction Manual

Introduction

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.

Safety Instructions

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 these 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.

1.2 Intended Use

This 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.

1.3 Receiving and Inspection

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

Important Safety Information

2.1 Warning

⚠️ 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.
• 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.

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.

2.2 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.
• DO NOT use this monitor for any purpose other than measuring blood pressure.
• 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 or thick clothing 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 210 mmHg" in section 6 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.

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 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.

2.3 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.

Battery Handling and Usage (Disposal)

• 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.

Remember to have a record of your blood pressure and pulse readings for your physician. A single measurement does not provide an accurate indication of your true blood pressure. Please use the Blood Pressure Diary to keep records of several readings over a certain period of time. To download PDF files of the diary, visit www.omron-healthcare.com.

Overview of Parts

The following parts are identified in the overview diagrams:

• A: Display - Shows measurement results and status.
• B: [START/STOP] button - Used to start and stop measurements.
• C: Battery compartment - Houses the batteries for the monitor.
• D: AC adapter jack - Port for connecting an optional AC adapter.
• E: Air jack - Connects the arm cuff to the monitor via the air tube.
• F: Arm cuff - The inflatable cuff that wraps around the upper arm.
• G: Air plug - The connector at the end of the air tube that plugs into the monitor.
• H: Air tube - Connects the arm cuff to the monitor.
• I: Marker - Indicates a specific part or feature.

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.

Limited Warranty

OMRON warrants this product for a period of 3 years from the date of purchase. OMRON will, without charge for labor or parts, repair or replace the defective product or any defective parts during this warranty period. The warranty does not cover transport costs, repairs by unauthorized persons, periodic maintenance, wear of optional parts, costs due to non-acceptance of a claim, accidental damages, or calibration service. Optional parts have a one (1) year warranty. For warranty service, contact the dealer or an authorized OMRON distributor. Visit www.omron-healthcare.com for customer service information. Warranty is granted only if the complete product is returned with the original invoice/cash ticket.

Maintenance

5.1 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.

5.2 Storage

• 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.
  • In locations exposed to vibrations or shocks.

5.3 Cleaning

• Do not use 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.

5.4 Calibration and Service

The accuracy of this blood pressure monitor has been carefully tested. 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 OMRON Customer Service.

Specifications

Note: These specifications are subject to change without notice. This monitor is clinically investigated according to the requirements of ISO 81060-2:2013. IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. Operating mode is classification in accordance with IEC 60601-1.

Correct Disposal of This Product

This marking indicates that the product should not be disposed of with other household wastes at the end of its working life. To prevent harm to the environment or human health, separate this product from other wastes and recycle it responsibly. Household users should contact their retailer or local government office for recycling details. Business users should contact their supplier.

Important Information Regarding Electromagnetic Compatibility (EMC)

HEM-7121J-E conforms to EN60601-1-2:2015 Electromagnetic Compatibility (EMC) standard. Further documentation is available at www.omron-healthcare.com.

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.
• This OMRON product is produced under the strict quality system of OMRON HEALTHCARE Co., Ltd., Japan. The Pressure Sensor is produced in Japan.
• Please report to the manufacturer and the competent authority of the Member State about any serious incident that has occurred in relation to this device.

Classification of BP (Blood Pressure)

2018 ESH/ESC* Guidelines for the management of arterial hypertension

Definitions of hypertension by office and home blood pressure levels:

* European Society of Hypertension (ESH) and European Society of Cardiology (ESC).

These ranges are from statistical values for blood pressure.

⚠️ Warning: NEVER diagnose or treat yourself based on your readings. ALWAYS consult with your physician.