Omron RS4 HEM-6181-E - Automatic Wrist Blood Pressure Monitor Manual

Table of Contents

Contents

1 Introduction
2 Important Safety Information
3 Know Your Monitor
4 Preparation
5 Using Your Monitor
- 5.1 Taking a Measurement
6 Using Memory Function
7 Other Settings
- 7.1 Disabling/Enabling Positioning Indicator
- 7.2 Deleting All Readings Stored in Memory
8 Error Messages and Troubleshooting
9 Maintenance
10 Specifications
11 Documents / Resources
- 11.1 References
- 11.2 Download manual

Introduction

This blood pressure monitor is to be worn on your wrist. This blood pressure monitor uses the oscillometric method of blood pressure measurement. When the cuff inflates, this monitor senses the pressure pulsations of the artery underneath the cuff. The pulses are called oscillometric pulses. The electronic pressure sensor displays a digital reading of blood pressure.

Safety Instructions
This instruction manual provides you with important information about the RS4 Automatic Wrist 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 OMRON retail outlet or distributor 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 adult patient population with wrist circumference ranging from 13.5 cm to 21.5 cm. This monitor detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. It is mainly designed for general household use.

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

Please read the Important Safety Information in this instruction manual before using this monitor.
Please follow this instruction manual thoroughly for your safety. Please keep for future reference. For specific information about your own blood pressure, CONSULT WITH YOUR PHYSICIAN.

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 wrist or a wrist under medical treatment.
DO NOT apply the wrist cuff on your wrist 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.
This product contains small parts that may cause a choking hazard if swallowed by infants, toddlers or children.

Battery Handling and Usage

Keep batteries out of the reach of infants, toddlers or children.

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 a wrist where intravascular access or therapy, or an arteriovenous (A-V) shunt, is present because of temporary interference to blood flow which 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 wrist cuff when it is applied on your wrist.
Remove the wrist 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 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 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.
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.
Ensure this monitor is not impairing blood circulation by observing the wrist while measurement is occurring.
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 of the monitor 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 wrist while taking a measurement.
Remain still and DO NOT talk while taking a measurement.
ONLY use this monitor on persons whose wrist 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 of operating and storage/transport temperature.
DO NOT crease the wrist cuff excessively.
Read and follow the "Correct Disposal of This Product" when disposing of the device and any used accessories or optional parts.
DO NOT use this monitor after the durable period has ended.

Battery Handling and Usage

DO NOT insert batteries with their polarities incorrectly aligned.
ONLY use 2 "AAA" alkaline 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.
ONLY use batteries specified for this monitor. Use of unsupported batteries may damage and/or may be hazardous to this monitor.

Know Your Monitor

Monitor, 2 "AAA" alkaline batteries, storage case, instruction manual

Monitor

Monitor Overview

Wrist cuff (Wrist circumference 13.5 cm to 21.5 cm)
Display
Battery compartment
[Memory] button
[Morning average] button
[START/STOP] button

Display and Symbols

A	Date and time display
B		Memory symbol Appears when viewing readings stored in the memory.
C	Systolic blood pressure reading
D	Diastolic blood pressure reading
E	Pulse display / Memory number Pulse rate appears after the measurement. When pressing the for approximately one second before the pulse rate appears on the display.button, the memory number appears
F		Deflation symbol Appears during cuff deflation.
G		Heartbeat symbol Flashes while taking a measurement.
H		Morning average symbol Appears when viewing the weekly average readings taken in the morning. Weekly averages for the measurement taken in the morning within 4 weeks appear on the display.
I		Average value symbol Appears when viewing the average readings of the latest 2 or 3 readings taken within 10 minutes span.
J		Battery symbol (low) Flashes when batteries are low.
J		Battery symbol (depleted) Appears when batteries are depleted.
K		Hypertension symbol Appears if your systolic blood pressure is 135 mmHg or above and/or the diastolic blood pressure is 85 mmHg or above.
		Morning hypertension symbol Appears when the morning weekly average is 135/85 mmHg or above.
L		Positioning indicator Your monitor has a built-in advanced positioning sensor that is used as an aid in determining if the monitor is at the correct height. The "" symbol appears when your monitor is at the correct position relative to your heart during a measurement. When your monitor is higher or lower position relative to your heart, the heart position locator bar will appear up above, or below the heart symbol to guide correct wrist positioning.
M		Irregular heartbeat symbol Appears along with readings when an irregular rhythm is detected 2 or more times during a measurement. An irregular heartbeat hythm is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while your monitor is measuring blood pressure. If it continues to appear, we recommend you to consult with and follow the directions of your physician.
N		Movement error symbol Appears along with readings when your body is moving during a measurement. If it appears, remove the wrist cuff, and wait for 2 to 3 minutes. Then, remain still and take another measurement.
O		Cuff wrap guide symbol (OK) Appears if the wrist cuff is wrapped around the wrist correctly while taking a measurement. It also appears when viewing past readings.
O		Cuff wrap guide symbol (loose) Appears if the wrist cuff is not wrapped around the wrist correctly while taking a measurement. It also appears when viewing past readings.

2013 ESH/ESC* Guidelines for the management of arterial hypertension
Definitions of hypertension by office and home blood pressure levels

	Office	Home
Systolic Blood Pressure	≥ 140 mmHg	≥ 135 mmHg
Diastolic Blood Pressure	≥ 90 mmHg	≥ 85 mmHg

These ranges are from statistical values for blood pressure.
* European Society of Hypertension (ESH) and European Society of Cardiology (ESC).

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

Preparation

Installing Batteries

Push down the hook of the battery cover and pull downward.
Insert 2 "AAA" alkaline batteries as indicated in the battery compartment.
Close the battery cover.

Note

When the "" symbol flashes on the display, it is recommended you replace batteries.
To replace batteries, turn your monitor off and remove all batteries. Then replace with 2 new alkaline batteries at the same time.
As soon as batteries are correctly installed, the year flashes on the date and time display to set the date and time.
Replacing batteries will not delete previous readings.
The supplied batteries may have a shorter life than new batteries.
Disposal of used batteries should be carried out in accordance with local regulations.

Setting the Date and Time

Note

Set your monitor to the correct date and time before taking a measurement for the first time.
As soon as batteries are correctly installed, the year flashes on the display of your monitor.

Press the or button once to adjust the year.
Press and hold the button to quickly advance the years.
Press and hold the button to quickly go backwards through the years.
Press the [START/STOP] button to confirm the year and the month will flash. Repeat the same steps to adjust the month, day, hour, and minute.
Press the [START/STOP] button to store the setting. It automatically turns off after 3 seconds.

Note

If you need to reset the date and time, replace batteries or press and hold the button until the year flashes, and set the date and time as above steps.

Blood Pressure Measurement Tips

To help ensure an accurate reading, follow these directions:

Stress raises blood pressure. Avoid taking measurements during stressful times.
Measurements should be taken in a quiet place.
It is important to take measurements at same times each day. Taking measurements in the morning and in the evening is recommended.
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.

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.

Applying the Wrist Cuff

Note

Following steps are for applying the wrist cuff to your left wrist. When you take a measurement on your right wrist, apply the wrist cuff using the same steps as on your left wrist.
The blood pressure can differ between the right wrist and the left wrist, and the measured blood pressure values can be different. OMRON recommends to always use the same wrist for measurement. If the values between both wrists differ substantially, please check with your physician as to which wrist to use for your measurements.

Remove tight-fitting, thick clothing and any accessories from your wrist while taking a measurement.

Apply the wrist cuff to your left wrist. Roll up sleeve. Make sure your sleeve is not rolled up too tightly on your arm. This may constrict the flow of blood in your arm.
Put your wrist through the cuff loop. Your palm and monitor display should both face upward.
Position the wrist cuff leaving a clearance of 1 to 2 cm between the cuff and the bottom of your palm.
Wrap the wrist cuff firmly around your wrist. Do not apply over clothing.
Check to make sure that there is no gap between your wrist and the cuff.

Note

Make sure the wrist cuff does not cover the protruding part of the wrist bone on the outside of your wrist.

Sitting Correctly

To take a measurement, you need to be relaxed and comfortably seated in a room with a comfortable temperature. Place your elbow on the table to support your arm.
How correctly measure your pressure - Step 1

Sit in a chair with your legs uncrossed and your feet flat on the floor.
Sit with your back and arm being supported.
Your monitor must be approximately the same level as your heart. If the monitor is too high above your heart, your blood pressure will be artificially low. If the monitor is too low below your heart, your blood pressure will be artificially high.
Relax your wrist and hand. Do not bend your wrist back, clench your fist, or bend your wrist forward.

Using Your Monitor

Taking a Measurement

Note

To stop the measurement, press the [START/STOP] button once to deflate the wrist cuff.

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.
Remain still and DO NOT talk while taking a measurement.

Press the [START/STOP] button. All symbols appear on the display before starting the measurement.

Check the positioning indicator.
Your monitor has a built-in advanced positioning sensor that is used as an aid in determining if the monitor is at the correct height. It has been designed to work with most people so that when your wrist is at the correct position relative to your heart, the "

" symbol will appear. When your wrist is higher or lower position relative to your heart, a locator bar will appear according to the wrist position. Due to difference in individual size and physique, this feature may not be helpful in all cases and you may wish to disable this feature. If you feel the position of the wrist according to positioning indicator's guidance does NOT match your heart level, disable this feature and follow your judgement.
Taking a Measurement - Step 1

	Monitor height	Positioning indicator
	Wrist is too high	Any locator bar (-) above the " " symbol appears.
	Proper position	The " " symbol appears.
	Wrist is too low	Any locator bar (-) below the " " symbol appears.

Note

After 5 seconds from pressing the [START/STOP] button, even if your monitor is not positioned properly, your monitor will start the measurement and the wrist cuff will start to inflate.

Remain still and do not move or talk until the entire measurement process is completed.
As the cuff inflates, your monitor automatically determines your ideal inflation level. This monitor detects your blood pressure and pulse rate during inflation. The "" symbol flashes at every heartbeat.
Note

The "" symbol appears if the wrist cuff is wrapped around the wrist correctly.
When the "" symbol is displayed, the wrist cuff is not applied correctly. Press the [START/STOP] button to turn your monitor off, then apply the cuff correctly.
After your monitor has detected your blood pressure and pulse rate, the cuff automatically deflates. Your blood pressure and pulse rate are displayed. If either the systolic or the diastolic reading is high, the "" symbol appears.

Press the [START/STOP] button to turn your monitor off.
Note

Your monitor will automatically turn off after 2 minutes.
Wait 2-3 minutes between measurements. The wait time allows the arteries to decompress and return to their premeasurement form. You may need to increase the wait time depending on your individual physiological characteristics.

Using Memory Function

Your monitor automatically stores up to 60 readings.

Viewing the Readings Stored in Memory

Press the button.

The Memory number appears for one second before the pulse rate is displayed. The most recent reading set is numbered "1".
Note

If the positioning indicator is enabled, the positioning indicator is displayed with the readings.
If the reading is high, the "" symbol appears.
If there are no readings stored in the memory, the screen to the right is displayed.
If the memory is full, the monitor will delete the oldest readings.

Press the button repeatedly to scroll through the previous readings stored in the memory.

Viewing the Average Reading

Your monitor can calculate an average reading based on the latest 2 or 3 readings taken within 10 minutes span.

When your monitor is off, press and hold the button for more than 2 seconds.
Note

If there are only 2 readings in the memory for that period, the average will be based on these 2 readings.
If the average reading is high, the "" symbol appears.

Viewing Morning Weekly Averages

Your monitor calculates and displays weekly averages for the measurements taken in the morning for 4 weeks.

Press the button once.
The morning weekly average for the current week "THIS WEEK" appears on the display. If the morning weekly average is high, the "" symbol appears.
Press the button repeatedly to display the average for the previous weeks. Your monitor displays "-1 WEEK" for the previous week's average, to "-3 WEEK" for the oldest set of averages.
Press the [START/STOP] button to turn off your monitor.

Morning Weekly Average Calculation
This is the average for the measurements taken during the morning (4:00 - 9:59) between Sunday and Saturday. Only the first 3 measurements taken in the morning between 4:00 - 9:59 will be used to calculate the morning average for each day.

Other Settings

Disabling/Enabling Positioning Indicator

The positioning indicator is enabled as default.

When your monitor is off, press and hold the for more than 10 seconds.

Note

Your monitor will automatically turn off after 3 seconds from the completion.
To enable the positioning indicator, follow the same steps as above.

Deleting All Readings Stored in Memory

Press the button, then the "" symbol appears.
While holding the button down, press and hold the [START/ STOP] button for more than 2 seconds.

Note

All readings will be deleted. You cannot partially delete the readings stored in the memory.

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.

Display/ Problem	Possible Cause	Solution
appears or the wrist cuff does not inflate.	The wrist cuff is not applied correctly.	Apply the wrist cuff correctly, then take another measurement.
appears or the wrist cuff does not inflate.	Air is leaking from the wrist cuff.	Contact your OMRON retail outlet or distributor.
appears	The wrist cuff is overinflated exceeding 300 mmHg.	Do not touch the wrist cuff while taking a measurement.
appears	You move or talk during a measurement. Vibrations disrupt a measurement.	Remain still and do not talk during a measurement.
appears	The pulse rate is not detected correctly.	Apply the wrist cuff correctly, then take another measurement. Remain still and sit correctly during a measurement. If the "" symbol continues to appear, we recommend you to consult with your physician.
appears
appears
appears	Your wrist is moved up and down during a measurement.	Do not move your wrist, then take another measurement.
appears	The monitor is malfunctioned.	Press the [START/ STOP] button again. If "Er" still appears, contact your OMRON retail outlet or distributor.
The heart symbol in the positioning indicator does not appear and a locator bar does not appear.	The positioning indicator is disabled.	Enable the positioning indicator.
flashes	Batteries are low.	Replacing all batteries with 2 new alkaline batteries is recommended.
appears or the monitor is turned off unexpectedly during a measurement	Batteries are depleted.	Immediately replace all batteries with 2 new alkaline batteries.
No power. Nothing appears on the display of the monitor.	Batteries are completely depleted.
No power. Nothing appears on the display of the monitor.	Battery polarities are not properly aligned.	Check the battery installation for proper placement.
Readings appear too high or too low.	Blood pressure varies constantly. Many factors including stress, time of day, and/or how you apply the wrist cuff, may affect your blood pressure.
Any other problems occur.	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 reinstall batteries. If the problem still persists, contact your OMRON retail outlet or distributor.

Maintenance

To protect your monitor from damage, please follow the directions below:

Changes or modifications not approved by the manufacturer will void the user warranty.

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.

Store your monitor in a clean, safe location.

Do not store your monitor:

If your monitor is 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 neutral soap to clean your monitor and wrist cuff, and then wipe them with a dry cloth.
Do not wash or immerse your monitor and wrist cuff in water.
Do not use gasoline, thinners or similar solvents to clean your monitor and wrist cuff.

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 unit inspected every two years to ensure correct functioning and accuracy. Please consult your authorised OMRON dealer or the OMRON Customer Service at the address given on the packaging or attached literature.

Specifications

Product category	Electronic Sphygmomanometers
Product description	Automatic Wrist Blood Pressure Monitor
Model (Code)	RS4 (HEM-6181-E)
Display	LCD digital display
Cuff pressure range	0 to 299 mmHg
Blood pressure measurement range	SYS: 60 to 260 mmHg DIA: 40 to 215 mmHg
Pulse measurement range	40 to 180 beats / min.
Accuracy	Pressure: ±3 mmHg Pulse: ±5% of display reading
Inflation	Automatic by electric pump
Deflation	Automatic rapid deflation
Measurement method	Oscillometric method
Operation mode	Continuous operation
IP classification	IP 22
Rating	DC3 V 3.0 W
Power source	2 "AAA" alkaline batteries 1.5V
Battery life	Approximately 300 measurements (using new alkaline batteries)
Durable period (Service life)	5 years
Operating conditions	+10°C to +40°C / 15 to 90% RH (noncondensing) / 800 to 1060 hPa
Storage / Transport conditions	-20°C to +60°C / 10 to 90% RH (noncondensing)
Weight	Approximately 86 g not including batteries
Dimensions	Approximately 93 mm (w) × 62 mm (h) × 20 mm (l) (not including the wrist cuff)
Measurable wrist circumference	13.5 to 21.5 cm
Memory	Stores up to 60 readings
Contents	Monitor, storage case, 2 "AAA" alkaline batteries, instruction manual
Protection against electric shock	Internally powered ME equipment
Applied part	Type BF (wrist cuff)
Maximum temperature of the applied part	Lower than +48°C

Note

These specifications are subject to change without notice.
In the clinical validation study, K5 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.
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, and against oblique falling water drops which may cause issues during a normal operation.
This device has not been validated for use on pregnant patients.