OMRON HEM-7124 Automatic Blood Pressure Monitor

Introduction

Thank you for purchasing the OMRON HEM-7124 Automatic Blood Pressure Monitor. The OMRON HEM-7124 is a compact, fully automatic blood pressure monitor, operating on the oscillometric principle. It measures your blood pressure and pulse rate simply and quickly. For comfortable controlled inflation without the need of pressure pre-setting or re-inflation, the monitor uses its advanced “IntelliSense” technology.

Intended Use: This product is designed to measure the blood pressure and pulse rate of people within the range of the designated arm cuff, following the instructions in this instruction manual. It is mainly designed for general household use.

Please follow this instruction manual thoroughly for your safety. Please keep for future reference. For specific information about your own blood pressure, CONSULT YOUR PHYSICIAN.

Contents: Monitor, arm cuff, instruction manual, battery set.

Diagram showing the monitor components: A. Display, B. START/STOP button, C. Battery compartment, D. Air jack, E. Arm cuff (Arm circumference 22 - 32 cm), F. Air plug, G. Air tube, H. Marker, I. Memory symbol, J. Systolic blood pressure, K. Diastolic blood pressure, L. Battery symbol (low/depleted), M. Heartbeat symbol (Flashes during measurement.), N. Pulse display, O. Deflation symbol.

Important Safety Information

General Usage Precautions:

• DO NOT adjust medication based on measurement results from this blood pressure monitor. Take medication as prescribed by your physician. Only a physician is qualified to diagnose and treat High Blood Pressure.
• Consult your physician before using this monitor for any of the following conditions: common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases. Note that PATIENT motion, trembling, shivering may affect the measurement reading.
• Do not use this monitor on the injured arm or the arm under medical treatment.
• Do not apply the arm cuff on the arm while being on an intravenous drip or blood transfusion.
• Consult your physician before using this monitor on the arm with an arterio-venous (A-V) shunt.
• Do not use this monitor with other medical electrical (ME) equipment simultaneously. This may result in incorrect operation of the monitor and/or cause an inaccurate reading.
• Do not use this monitor in the area where HF surgical equipment, MRI, or CT scanner exists, or in the oxygen rich environment. This may result in incorrect operation of the monitor and/or cause an inaccurate reading.
• The air tube may cause accidental strangulation in infants.
• Contains small parts that may cause a choking hazard if swallowed by infants.
• Stop using this monitor and consult your physician if you experience skin irritation or other troubles.

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

General Usage (Caution):

• Always consult your physician. Self-diagnosis of measurement results and self-treatment are dangerous.
• Consult your physician before using this monitor for any of the following conditions: If you have had a mastectomy. People with severe blood flow problems or blood disorders as cuff inflation can cause bruising.
• Do not take measurements more than necessary. It may cause bruising due to blood flow interference.
• If there are any abnormalities during the measurement, remove the arm cuff.
• Do not use this monitor on infants or persons who cannot express their intentions.
• Do not inflate the arm cuff more than necessary.
• Do not use this monitor for any purpose other than measuring blood pressure.
• Use only the approved arm cuff for this monitor. Use of other arm cuffs may result in incorrect measurement results.
• During measurement, make sure that no mobile phone or any other electrical devices that emit electromagnetic fields is within 30cm of this monitor. This may result in incorrect operation of the monitor and/or cause an inaccurate reading.
• Do not disassemble the monitor or arm cuff. This may cause an inaccurate reading.
• Do not use in a location with moisture, or a location where water may splash on this monitor. This may damage this monitor.
• Do not use this monitor in a moving vehicle (car, airplane).

Battery Usage:

• Do not insert the batteries with their polarities incorrectly aligned.
• Use only four “AA” alkaline or manganese batteries with this monitor. Do not use other types of batteries. Do not use new and used batteries together.
• Remove the batteries if this monitor will not be used for 3 months or more.
• Use the battery within the recommended period mentioned to it.

General Precautions:

• Do not forcibly bend the arm cuff or bend the air tube excessively.
• Do not fold or kink the air tube while taking a measurement. This may cause harmful injury by interrupting blood flow.
• To unplug the air plug, pull on the air plug at the connection with the monitor, not the tube itself.
• Do not apply strong shocks and vibrations to or drop the monitor and arm cuff.
• Do not inflate the arm cuff when it is not wrapped around your arm.
• Read and follow the “Important information regarding Electro Magnetic Compatibility (EMC)” in the “6. Specifications”.
• Read and follow the “Correct Disposal of This Product” in the Technical Data Section when disposing of this monitor and any used accessories or optional parts.
• Do not use this monitor outside the specified environment. It may cause an inaccurate reading.
• Dispose of this monitor, components and optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution.
• Please check (for example, by observation of the limb concerned) if this monitor is not causing a prolonged impairment of PATIENT blood circulation.
• If this monitor is stored at the maximum or minimum storage and transport temperature and is moved to an environment with a temperature of 20°C, we recommend waiting for approx. 2 hours before using the monitor.

1. Know Your Monitor

The monitor is a device that measures blood pressure and pulse rate. It is designed for general household use.

2. Preparation

2.1 Battery Installation

1. Remove the battery cover.
2. Insert 4 “AA” batteries as indicated in the battery compartment.
3. Replace the battery cover.

Notes:

• When the depleted battery symbol ( ⚠ ) appears on the display, turn the monitor off and remove all the batteries. Replace with 4 new batteries at the same time. Long life alkaline batteries are recommended.
• The measurement values continue to be stored in memory even after the batteries are replaced.
• The supplied batteries may have a shorter life.
• Disposal of used batteries should be carried out in accordance with the national/local regulations for the disposal of batteries.

3. Using the Monitor

Before Taking a Measurement:

1. Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating for 30 minutes before taking a measurement.
2. Rest for at least 5 minutes before taking the measurement.
3. Stress raises blood pressure. Avoid taking measurements during stressful times.
4. Measurements should be taken in a quiet place.
5. Remove tight-fitting clothing from your arm.

3.1 Applying the Arm Cuff

Remove tight-fitting clothing or tight rolled up sleeve from your left upper arm. Do not place the arm cuff over thick clothes.

1. Insert the air plug into the air jack securely. ✔
2. Wrap the arm cuff firmly in place around your left upper arm. The bottom edge of the arm cuff should be 1 to 2 cm above the elbow. The air tube is on the inside of your arm and aligned with your middle finger.
3. Secure closed with the fabric fastener.

Notes:

• When you take a measurement on the right arm, the air tube will be at the side of your elbow. Be careful not to rest your arm on the air tube.
• The blood pressure can differ between the right arm and the left arm, also the measured blood pressure values can be different. OMRON recommends to always use the same arm for measurement. If the values between both arms differ substantially, please check with your physician which arm to use for your measurements.

3.2 How to Sit Correctly

To take a measurement, you need to be relaxed and comfortably seated at a comfortable room temperature.

• Sit on a chair with your legs uncrossed and your feet flat on the floor.
• Sit with your back and arm being supported.
• The arm cuff should be placed on your arm at the same level as your heart.

3.3 Taking a Measurement

If your systolic pressure is more than 210 mmHg: After the arm cuff starts to inflate, press and hold the START/STOP button until the monitor inflates 30 to 40 mmHg higher than your expected systolic pressure.

1. Press the START/STOP button. The arm cuff will start to inflate automatically.
2. Remove the arm cuff.
3. Press the START/STOP button to turn the monitor off. The monitor automatically stores the measurement result in its memory. It will automatically turn off after 2 minutes.

Notes:

• To stop a measurement, press the START/STOP button once to release the air in the arm cuff.
• Remain still and do not talk while taking a measurement.
• Wait 2-3 minutes before taking another measurement. Waiting between measurements allows the arteries to return to the condition prior to taking a measurement.

Note: If your systolic or diastolic pressure is outside the standard range (above 134/84 mmHg) the Heartbeat symbol ( ♥ ) will blink. Please refer to Section 3.3.

3.4 Using the Memory Function

The monitor automatically stores the last measurement values (blood pressure and pulse rate).

To View the Measurement Values Stored in Memory:

1. Press and hold the START/STOP button for more than 5 seconds. The last measurement value is displayed along with the memory symbol.
2. Press the START/STOP button to turn the monitor off. It will automatically turn off after 2 minutes.

To Delete the Values Stored in Memory: Press and hold the START/STOP button for more than 15 seconds.

Notes:

• If your systolic or diastolic pressure is outside the standard range, the heartbeat symbol will blink when the measurement result is displayed.
• If there are no measurements results stored in the memory, the screen to the right is displayed.

4. Error Messages and Troubleshooting

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

Error Display:

5. Maintenance and Storage

5.1 Maintenance

To protect your monitor from damage, please observe the following:

• Store the monitor and the components in a clean, safe location.
• Do not use any abrasive or volatile cleaners.
• Do not wash the monitor and any components or immerse them in water.
• Do not use petrol, thinners or similar solvents to clean the monitor.
• Use a soft and dry cloth, or a soft and moistened cloth and neutral soap to clean on the monitor and the arm cuff.
• Changes or modifications not approved by the manufacturer will void the user warranty. Do not disassemble or attempt to repair the monitor or components. Consult your local OMRON representative.

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 device inspected every 2 years to ensure correct functioning and accuracy. Please consult your local OMRON representative.

5.2 Storage

1. Unplug the air plug from the air jack.
2. Gently fold the air tube into the arm cuff.

Note: Do not bend or crease the air tube excessively.

Do not store your monitor in the following situations:

• If your monitor and other components are wet.
• Locations exposed to extreme temperatures, humidity, direct sunlight, dust or corrosive vapours such as bleach.
• Locations exposed to vibrations, shocks or where it will be at an angle.

5.3 Optional Parts

Arm Cuff:

• Medium Cuff: HEM-CR24 (Arm circumference 22 - 32 cm)
• Wide Range Soft Cuff: HEM-RML31 (Arm circumference 22 - 42 cm)

6. Specifications

Notes:

• These specifications are subject to change without notice.
• In the clinical validation study, the 5th phase was used on 85 subjects for determination of diastolic blood pressure.
• This monitor is clinically investigated according to the requirements of ISO 81060-2:2013.
• This monitor has not been validated for use on pregnant patients.
• IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This monitor is protected against solid foreign objects of 12.5 mm diameter and greater such as a finger.

Important information regarding Electro Magnetic Compatibility (EMC):

HEM-7124 manufactured by OMRON HEALTHCARE Co., Ltd. conforms to EN60601-1-2:2015 Electro Magnetic Compatibility (EMC) standard. Further documentation in accordance with this EMC standard is available at http://www.omronhealthcare-ap.com/emc-information. Refer to the EMC information for HEM-7124 on the website.

Symbols description:

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.

Manufacturer Information

OMRON HEALTHCARE Co., Ltd.
53, Kunotsubo, Terado-cho, Muko, KYOTO, 617-0002 JAPAN

OMRON HEALTHCARE EUROPE B.V.
Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS
www.omron-healthcare.com

OMRON HEALTHCARE SINGAPORE PTE LTD.
438A Alexandra Road, #05-05/08 Alexandra Technopark, Singapore 119967
www.omronhealthcare-ap.com

OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.
Binh Duong Province, VIETNAM

This device fulfils the provisions of EC directive 93/42/EEC (Medical Device Directive).

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 Core component for OMRON blood pressure monitors, which is the Pressure Sensor, is produced in Japan.