OMRON HEM-6181 Wrist Blood Pressure Monitor

Introduction

Thank you for purchasing the OMRON HEM-6181 Wrist Blood Pressure Monitor. This monitor is designed for use on the wrist and employs the oscillometric method for blood pressure measurement. It senses pressure pulsations from the artery beneath the cuff, which are then processed by an electronic pressure sensor to display digital readings.

Safety Instructions

This manual contains important information for the safe and proper use of the OMRON HEM-6181. Please read and understand all instructions. Consult your local OMRON representative with any questions. For specific health advice, consult your physician.

Intended Use

This digital monitor is intended for measuring blood pressure and pulse rate in adults with wrist circumferences from 13.5 cm to 21.5 cm. It alerts users to irregular heartbeats detected during measurement and is primarily for general household use.

Receiving and Inspection

Inspect the monitor for damage upon removal from packaging. Do not use if damaged; contact your local OMRON representative.

Important Safety Information

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

• DO NOT use on infants, toddlers, children, or persons unable to express themselves.
• DO NOT adjust medication based on readings; always follow physician's prescriptions.
• DO NOT use on an injured wrist or a wrist under medical treatment.
• DO NOT apply the cuff during an intravenous drip or blood transfusion.
• DO NOT use near high-frequency surgical equipment, MRI, or CT scanners, as this may cause incorrect operation or inaccurate readings.
• DO NOT use in oxygen-rich environments or near flammable gas.
• Consult a physician before use if you have common arrhythmias, arterial sclerosis, poor perfusion, diabetes, pregnancy, pre-eclampsia, or renal disease, as these conditions or patient motion can affect readings.
• NEVER self-diagnose or self-treat based on readings; always consult your physician.
• Keep the product away from infants and children as it contains small parts that may cause choking hazards.

Caution: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury or equipment damage.

• Stop use and consult a physician if skin irritation or discomfort occurs.
• Consult a physician before use on a wrist with intravascular access/therapy or an A-V shunt.
• Consult a physician before use if you have had a mastectomy.
• Consult a physician before use if you have severe blood flow problems or blood disorders, as cuff inflation may cause bruising.

Battery Handling and Usage

• Keep batteries out of reach of children.
• DO NOT take measurements more often than necessary to avoid bruising from blood flow interference.
• ONLY inflate the cuff when applied to the wrist.
• Remove the cuff if it does not start deflating during measurement.
• DO NOT use the monitor for purposes other than blood pressure measurement.
• Ensure no mobile devices or other electrical devices emitting electromagnetic fields are within 30 cm during measurement.
• DO NOT disassemble or attempt to repair the monitor.
• DO NOT use in wet locations or where splashing may occur.
• DO NOT use in a moving vehicle.
• DO NOT drop or subject the monitor to strong shocks or vibrations.
• DO NOT use in extreme humidity or temperature conditions (refer to Specifications).
• Ensure the monitor does not impair blood circulation by observing the wrist during measurement.
• DO NOT use in high-use environments like medical clinics or physician offices.
• DO NOT use simultaneously with other medical electrical (ME) equipment.
• Avoid bathing, drinking alcohol or caffeine, smoking, exercising, and eating for at least 30 minutes before measurement.
• Rest for at least 5 minutes before measurement.
• Remove tight clothing and accessories from the wrist.
• Remain still and DO NOT talk during measurement.
• ONLY use on persons with wrist circumferences within the specified range.
• Ensure the monitor acclimates to room temperature after extreme temperature changes (wait approx. 2 hours).
• DO NOT crease the wrist cuff excessively.
• Follow disposal instructions in Chapter 9.
• DO NOT use after the durable period has ended (refer to Specifications).
• DO NOT insert batteries with incorrect polarity.
• ONLY use 2 "AAA" alkaline batteries; do not mix types, brands, or new/used batteries.
• Remove batteries if the monitor will not be used for a long period.
• If battery fluid gets into eyes, rinse immediately with plenty of water and consult a physician.
• If battery fluid gets on skin, wash immediately with soap and water; consult a physician if irritation persists.
• DO NOT use expired batteries.
• Periodically check batteries.
• ONLY use specified batteries.

1. Know Your Monitor

1.1 Contents

• Monitor
• 2 "AAA" alkaline batteries
• Storage case
• Instruction manual

1.2 Monitor Components

The monitor includes:

• a. Wrist cuff: For wrist circumferences 13.5 cm to 21.5 cm.
• b. Display: LCD digital display.
• c. Battery compartment: Houses the batteries.
• d. [Memory] button: For accessing stored readings.
• e. [Morning average] button: For viewing morning averages.
• f. [START/STOP] button: To start or stop measurements.

1.3 Display and Symbols

The display shows various information and symbols:

• A. Date and time display: Shows current date and time.
• B. Memory symbol: Appears when viewing stored readings.
• C. Systolic blood pressure reading: Displays the systolic value.
• D. Diastolic blood pressure reading: Displays the diastolic value.
• E. Pulse display / Memory number: Shows pulse rate and memory number.
• F. Deflation symbol: Appears during cuff deflation.
• G. Heartbeat symbol: Flashes during measurement.
• H. Morning average symbol: Appears when viewing morning weekly averages.
• I. Average value symbol: Appears when viewing average of last 2-3 readings.
• J. Battery symbol (low/depleted): Indicates low or depleted batteries.
• K. Hypertension symbol: Appears if systolic BP is ≥ 135 mmHg or diastolic BP is ≥ 85 mmHg.
• L. Positioning indicator: A sensor aids in correct wrist height relative to the heart. The [heart symbol] appears when correctly positioned. Locator bars indicate if the wrist is too high or too low.
• M. Irregular heartbeat symbol: Appears with readings if an irregular rhythm (25% more or less than average) is detected multiple times. Consult physician if it persists.
• N. Movement error symbol: Appears if body movement occurs during measurement.
• O. Cuff wrap guide symbol (OK/loose): Indicates if the cuff is wrapped correctly ([cuff OK]) or loosely ([cuff loose]).

Hypertension Definitions (2013 ESH/ESC Guidelines)

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

2. Preparation

2.1 Installing Batteries

1. Push down the hook of the battery cover and pull downward.
2. Insert 2 "AAA" alkaline batteries, observing polarity.
3. Close the battery cover.

Note: Replace batteries when the [low battery symbol] flashes. Replacing batteries does not delete readings. The year will flash upon battery installation for date/time setting.

2.2 Setting the Date and Time

Set the correct date and time before the first measurement.

1. Upon battery installation, the year flashes. Press the [button] to adjust the year. Hold the [button] to advance or go backwards quickly.
2. Press [START/STOP] to confirm the year; the month will flash. Repeat for month, day, hour, and minute.
3. Press [START/STOP] to store settings. The monitor turns off after 3 seconds.

Note: To reset, replace batteries or press and hold the [button] until the year flashes.

2.3 Blood Pressure Measurement Tips

• Avoid stressful times; take measurements in a quiet place.
• Take measurements at the same times each day (morning and evening recommended).
• Record readings for your physician; a single measurement is not indicative of true blood pressure.

Caution: Avoid bathing, alcohol, caffeine, smoking, exercising, and eating for 30 minutes prior. Rest for 5 minutes before measurement.

2.4 Applying the Wrist Cuff

Follow these steps for the left wrist (similar for the right, but use the same wrist consistently).

1. Apply the cuff to your left wrist. Roll up your sleeve, ensuring it doesn't constrict blood flow.
2. Put your wrist through the cuff loop so the palm and monitor display face upward.
3. Position the cuff 1 to 2 cm from the bottom of your palm.
4. Wrap the cuff firmly around the wrist, not over clothing. Ensure no gap between wrist and cuff. Do not cover the wrist bone.

2.5 Sitting Correctly

Sit relaxed in a comfortable room temperature. Support your arm on a table.

• Sit with legs uncrossed and feet flat on the floor.
• Ensure your back and arm are supported.
• Position the monitor at heart level. Too high lowers BP readings; too low raises them.
• Relax your wrist and hand; do not bend it.

3. Using Your Monitor

3.1 Taking a Measurement

1. Press the [START/STOP] button. All symbols appear briefly.
2. Check the positioning indicator: The [heart symbol] appears when the wrist is at the correct height. Locator bars guide positioning. If the indicator guidance doesn't match your heart level, you can disable it (Section 5.1).
3. Remain still and silent during measurement. The cuff inflates, and the monitor detects BP and pulse. The [heartbeat symbol] flashes. The [cuff OK] cuff wrap symbol may appear if wrapped correctly.
4. After measurement, the cuff deflates automatically. Readings are displayed. The [hypertension symbol] appears if readings are high.
5. Press [START/STOP] to turn off the monitor. It auto-turns off after 2 minutes.

Note: Wait 2-3 minutes between measurements.

4. Using Memory Function

The monitor stores up to 60 readings.

4.1 Viewing Readings Stored in Memory

1. Press the [button]. The memory number appears, followed by the pulse rate. The most recent reading is "1".
2. Press the [button] repeatedly to scroll through previous readings.

Note: The [positioning indicator] may display with readings. The [hypertension symbol] appears for high readings. If memory is full, oldest readings are deleted.

4.2 Viewing the Average Reading

Calculate an average of the latest 2 or 3 readings taken within 10 minutes.

1. When the monitor is off, press and hold the [button] for over 2 seconds.

Note: If only 2 readings are available, the average is based on those. The [hypertension symbol] appears for high averages.

4.3 Viewing Morning Weekly Averages

The monitor calculates weekly averages for morning measurements (4:00 AM - 9:59 AM) over 4 weeks.

1. Press the [button] once to see the current week's morning average ("THIS WEEK"). The [hypertension symbol] appears for high averages.
2. Press the [button] repeatedly to view averages for previous weeks (-1 WEEK to -3 WEEK).
3. Press [START/STOP] to turn off the monitor.

Morning Weekly Average Calculation: Uses the first 3 morning measurements (4:00 AM - 9:59 AM) from Sunday to Saturday.

5. Other Settings

5.1 Disabling/Enabling Positioning Indicator

The positioning indicator is enabled by default.

1. When the monitor is off, press and hold the [button] for over 10 seconds to disable or enable it.

6. Error Messages and Troubleshooting

Check for nearby electrical devices (within 30 cm). If problems persist, consult the table below.

7. Maintenance

7.1 Maintenance

• Do not make unauthorized modifications to avoid voiding warranty.
• DO NOT disassemble or attempt to repair the monitor.

7.2 Storage

Store the monitor in its case in a clean, safe location. Avoid moisture, extreme temperatures, direct sunlight, dust, corrosive vapors, vibrations, or shocks.

7.3 Cleaning

• Do not use abrasive or volatile cleaners.
• Clean the monitor and cuff with a soft dry cloth or a soft cloth moistened with mild soap, then wipe dry.
• Do not wash or immerse in water.
• Do not use solvents like gasoline or thinners.

7.4 Calibration and Service

The monitor is designed for long service life. It is recommended to have it inspected every two years for accuracy. Consult your OMRON dealer or representative.

8. Specifications

Note: Specifications are subject to change without notice. This device is clinically investigated according to ISO 81060-2:2013. IP classification details are provided.

9. Guidance and Manufacturer's Declaration

This device complies with EC directive 93/42/EEC (Medical Device Directive) and European Standard EN1060.

Symbols Description

• Applied part - Type BF: Indicates the type of protection against electric shock.
• IP XX: Ingress Protection degree as per IEC 60529.
• CE Marking: Conforms to EU regulations.
• Serial number: Unique product identifier.
• Temperature limitation: Indicates operating/storage temperature range.
• Humidity limitation: Indicates operating/storage humidity range.
• Atmospheric pressure limitation: Indicates operating/storage pressure range.
• [Instruction Manual Symbol]: Indicates the need to consult the instruction manual.
• [Positioning Symbol]: Indicates correct positioning for the monitor on the wrist.
• Measurable wrist circumference: Specifies the range the cuff fits.
• Battery: Indicates battery power.
• Direct current: Indicates DC power source.

Important Information Regarding Electro Magnetic Compatibility (EMC)

The HEM-6181 conforms to EN60601-1-2:2015 EMC standard. Further information is available at http://www.omronhealthcare-ap.com/emc-information.

Correct Disposal of This Product (Waste Electrical & Electronic Equipment)

This marking indicates the product should not be disposed of with household waste. Please separate it for responsible recycling to promote sustainable resource reuse. Contact retailers or local government for environmentally safe recycling options.

Manufacturer Information

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

EU-representative: OMRON HEALTHCARE EUROPE B.V., Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS (www.omron-healthcare.com)

Asia Pacific HQ: OMRON HEALTHCARE SINGAPORE PTE LTD., 438A Alexandra Road, #05-05/08 Alexandra Technopark, Singapore 119967 (www.omronhealthcare-ap.com)

Production Facility: OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD., Binh Duong Province, Vietnam