Omron RS3 Intelli IT - User Manual

Introduction
Important Safety Information
1. Know Your Monitor
2. Preparation
3. Using Your Monitor
4. Other Settings
5. Error Messages and Troubleshooting
6. Maintenance
7. Specifications
8. Limited Warranty
9. Guidance and Manufacturer’s Declaration
Thank you for purchasing the RS3 Intelli IT Automatic Wrist Blood
Pressure Monitor. 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 RS3 Intelli IT 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.
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.
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 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.
Data Transmission
• This product emits radio frequencies (RF) in the 2.4 GHz
band. DO NOT use this product in locations where RF is
restricted, such as on an aircraft or in hospitals. Turn off the
Bluetooth feature in this monitor and remove batteries when
in RF restricted areas.
Battery Handling and Usage
• Keep batteries out of the reach of infants, toddlers or
children.
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.
Automatic Wrist Blood
Pressure Monitor
RS3 Intelli IT (HEM-6161T-E)
Instruction Manual
IM-HEM-6161T-E-EN-01-09/2018
4602352-2A
Table of Contents
Introduction
Important Safety Information
• Consult with your physician before using this monitor on a
wrist where intravascular access or therapy, or an arterio-
venous (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. Refer to chapter 7.
• 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, refer to chapter 7.
• DO NOT crease the wrist cuff excessively.
• Read and follow the “Correct Disposal of This Product” in
chapter 9 when disposing of the device and any used
accessories or optional parts.
• DO NOT use this monitor after the durable period has ended.
Refer to chapter 7.
Data Transmission
• DO NOT replace batteries while your reading is being
transferred to your smart device. This may result in the
incorrect operation of this monitor and failure to transfer your
blood pressure data.
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.
1.1 Contents
Monitor, 2 “AAA” alkaline batteries, storage case, instruction manual,
setup instructions
1.2 Monitor
a. Wrist cuff
(Wrist circumference 13.5 cm to 21.5 cm)
b. Display
c. Battery compartment
d. [Connection] button
e. [START/STOP] button
1. Know Your Monitor
a
c
b
d
e
1.3 Display and Symbols
2013 ESH/ESC* Guidelines for the management of
arterial hypertension
Definitions of hypertension by office and home blood pressure levels
These ranges are from statistical values for blood pressure.
Warning
• NEVER diagnose or treat yourself based on your readings.
ALWAYS consult with your physician.
2.1 Installing Batteries
1. Push down the hook of the battery
cover and pull downward.
2. Insert 2 “AAA” alkaline batteries as
indicated in the battery compartment.
A
Systolic blood pressure reading
B
Diastolic blood pressure reading
C
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.
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.
D
Heartbeat symbol
Flashes while taking a measurement.
Appears if your systolic blood pressure is 135
mmHg or above and/or the diastolic blood pressure
is 85 mmHg or above.
E
Deflation symbol
Appears during cuff deflation.
F
Bluetooth ON symbol
Appears when Bluetooth is enabled.
Bluetooth OFF symbol
Appears when Bluetooth is disabled.
G
Sync symbol
Flashes/appears when your data needs to be
transferred because the stored memory is either
almost, or completely full. Once you pair your
monitor with a smart device, transfer your readings
immediately before the monitor deletes the oldest
readings. Up to 30 readings can be stored in the
internal memory.
H
Battery symbol (low)
Flashes when batteries are low.
Battery symbol (depleted)
Appears when batteries are depleted.
I
Irregular heartbeat symbol
Appears along
with readings
when an irregular
rhythm is detected
2 or more times
during a
measurement.
An irregular
heartbeat rhythm
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.
J
Pulse display / Memory number
Pulse rate appears after the measurement.
Office Home
Systolic Blood
Pressure
≥ 140 mmHg ≥ 135 mmHg
Diastolic Blood
Pressure
≥ 90 mmHg ≥ 85 mmHg
off
B
A
C
E
D
H
F
G
I
J
Irregular Heartbeat
Normal Heartbeat
Pulse
Blood pressure
Blood pressure
Short
Long
Pulse
* European Society of Hypertension (ESH) and European Society
of Cardiology (ESC).
2. Preparation
3. 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.
• 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.
• As soon as batteries are correctly installed, “P” flashes on the
display to start pairing. To pair your monitor, refer to section 2.2. If
your monitor has already been paired with your smart device when
batteries are installed, "O" will flash. If it flashes, transfer your
readings.
2.2 Pairing Your Monitor with a Smart Device
Review the list of compatible smart devices at
www.omronconnect.com/devices/
1. Enable Bluetooth on your smart device.
2. Download and install the free “OMRON connect” app
onto your smart device.
If you already have the “OMRON connect” app, open the app
and add your new monitor.
3. Open the app on your smart device and follow the
instructions.
4. Confirm that your monitor is
connected successfully.
When your monitor is connected
successfully to your smart device, the
“OK” symbol appears.
Note
• If the “Err” symbol appears, follow the
instructions in the “OMRON connect”
app.
• Your monitor automatically turns off
after 10 seconds without any
operations.
• Any readings currently saved in the memory of your monitor
are automatically transferred to the app after successful
completion of the pairing process.
• Please be aware that OMRON will not be responsible for the
loss of data and/or information in the app.
• “OMRON connect” is the only app that we recommend to use
with your monitor to transfer data correctly.
2.3 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.
Caution
• 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.
2.4 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.
Caution
• Remove tight-fitting, thick clothing and any accessories from your
wrist while taking a measurement.
1. 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.
2. Put your wrist through the cuff loop.
Your palm and monitor display should both
face upward.
1
2
Wrist cuff
3. Position the wrist cuff leaving a
clearance of 1 to 2 cm between
the cuff and the bottom of your
palm.
4. 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.
2.5 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.
• 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.
3.1 Taking a Measurement
Note
• To stop the measurement, press the [START/STOP] button once
to deflate the wrist cuff.
Caution
• 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.
1. Press the [START/STOP] button.
All symbols appear on the display before starting the
measurement.
2. 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 (refer to
section 1.3), the “ ” symbol appears.
3. 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 pre-
measurement form. You may need to increase the wait time
depending on your individual physiological characteristics.
1 to 2 cm
3. Using Your Monitor
START
INFLATING COMPLETED

Summary

Introduction

Safety Instructions

Provides information for safe and proper use of the monitor.

Intended Use

Defines the device's purpose and target user population.

Important Safety Information

Data Transmission

Information about RF emission and restrictions.

Battery Handling and Usage

Guidelines for safe battery use and storage.

1. Know Your Monitor

1.2 Monitor

Details the physical components of the blood pressure monitor.

2. Preparation

2.1 Installing Batteries

Step-by-step guide for inserting batteries into the monitor.

2.2 Pairing Your Monitor with a Smart Device

Instructions for connecting the monitor to a smartphone app.

2.3 Blood Pressure Measurement Tips

Advice for obtaining accurate blood pressure readings.

2.4 Applying the Wrist Cuff

Detailed steps for correctly wearing the wrist cuff.

2.5 Sitting Correctly

3. Using Your Monitor

3.1 Taking a Measurement

Step-by-step process for performing a blood pressure measurement.

3.2 Disabling;Enabling Bluetooth

4. Other Settings

4.1 Restoring Your Monitor to the Default Settings

Instructions to reset the monitor to factory defaults.

5. Error Messages and Troubleshooting

6. Maintenance

6.1 Maintenance

General advice for maintaining the monitor's condition.

6.2 Storage

Guidelines for storing the monitor when not in use.

6.3 Cleaning

Instructions on how to clean the monitor and cuff.

6.4 Calibration and Service

Information on accuracy checks and professional servicing.

7. Specifications

8. Limited Warranty

9. Guidance and Manufacturers Declaration

Symbols description

Explains various symbols used on the monitor and in the manual.

Important information regarding Electro Magnetic Compatibility (EMC)

Notes on EMC compliance and potential interference.

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

Guidance on environmentally sound disposal of the device.

Overview

1. Function Description
2. Usage Features
3. Maintenance Features

This document describes the OMRON RS3 Intelli IT Automatic Wrist Blood Pressure Monitor (HEM-6161T-E), a digital monitor designed for measuring blood pressure and pulse rate in adult patients. It utilizes the oscillometric method to detect pressure pulsations from the artery under the cuff, displaying digital readings of blood pressure. The device is intended for general household use and can detect irregular heartbeats, providing a warning signal with readings.

Function Description

The OMRON RS3 Intelli IT is an automatic wrist blood pressure monitor that measures systolic and diastolic blood pressure, as well as pulse rate. It operates by inflating a cuff around the wrist and sensing the pressure pulsations of the artery. The monitor displays these readings digitally. A key feature is its ability to detect irregular heartbeats, alerting the user to potential cardiac arrhythmias.

The monitor includes a "Cuff wrap guide symbol (OK)" which appears if the wrist cuff is correctly applied during measurement, and also when viewing past readings. Conversely, a "Cuff wrap guide symbol (loose)" indicates incorrect cuff application. A "Heartbeat symbol" flashes during measurement and appears if systolic blood pressure is 135 mmHg or above, and/or diastolic blood pressure is 85 mmHg or above, aligning with the 2013 ESH/ESC Guidelines for the management of arterial hypertension. A "Deflation symbol" is shown during cuff deflation.

Bluetooth connectivity is integrated, indicated by a "Bluetooth ON symbol" when enabled and a "Bluetooth OFF symbol" when disabled. A "Sync symbol" flashes or appears when data needs to be transferred to a smart device, particularly when the internal memory is almost or completely full. The monitor can store up to 30 readings internally.

Battery status is indicated by a "Battery symbol (low)" which flashes when batteries are low, and a "Battery symbol (depleted)" which appears when batteries are depleted. The "Irregular heartbeat symbol" appears with readings if an irregular rhythm is detected two or more times during a measurement. An irregular heartbeat is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while measuring blood pressure. If this symbol persists, users are advised to consult their physician. The "Pulse display / Memory number" shows the pulse rate after measurement.

Usage Features

To use the monitor, two "AAA" alkaline batteries must be installed. The battery compartment is accessed by pushing down a hook and pulling the cover downward. Batteries should be inserted with correct polarities. When the "battery" symbol flashes, it's recommended to replace the batteries. Used batteries should be disposed of according to local regulations.

The monitor can be paired with a smart device via Bluetooth. Users need to enable Bluetooth on their smart device, download and install the free "OMRON connect" app, and follow the in-app instructions for pairing. A "OK" symbol on the monitor confirms successful connection. If an "Err" symbol appears, troubleshooting via the app is recommended. Readings are automatically transferred to the app after successful pairing and measurement, or can be transferred manually by pressing the "Connection" button.

For accurate blood pressure measurements, several tips are provided: avoid taking measurements during stressful times, measure in a quiet place, and take measurements at the same times each day (morning and evening are recommended). Users should rest for at least 5 minutes before measuring, remove tight-fitting clothing and accessories from the wrist, and remain still without talking during measurement. The monitor should only be used on wrists within the specified circumference range (13.5 cm to 21.5 cm). It's crucial for the monitor to acclimate to room temperature before use, especially after extreme temperature changes.

Applying the wrist cuff correctly is essential. The cuff should be applied to the left wrist (or right wrist using the same steps) with a clearance of 1 to 2 cm between the cuff and the bottom of the palm. It should be wrapped firmly, ensuring no gap between the wrist and cuff, and not covering the protruding wrist bone. The palm and monitor display should face upward.

Correct sitting posture is vital for accurate readings: sit in a chair with legs uncrossed and feet flat on the floor, with back and arm supported. The monitor should be approximately at the same level as the heart.

To take a measurement, press the [START/STOP] button. All symbols appear on the display before measurement begins. Users must remain still and silent until the measurement is complete. The monitor automatically determines the ideal inflation level and detects blood pressure and pulse rate. If the "Cuff wrap guide symbol (loose)" appears, the cuff is not applied correctly, and the user should turn off the monitor, reapply the cuff, and restart. After detecting readings, the cuff deflates, and blood pressure and pulse rate are displayed. If readings are high, the "Heartbeat symbol" appears. To turn off the monitor, press the [START/STOP] button again, or it will automatically turn off after 2 minutes. A wait of 2-3 minutes between measurements is recommended to allow arteries to decompress.

Bluetooth can be disabled in restricted areas (e.g., aircraft, hospitals) by pressing and holding the "Connection" button for more than 10 seconds when the monitor is off. "OFF" appears on the display, and the Bluetooth OFF symbol is shown. To re-enable, press and hold the "Connection" button for more than 2 seconds.

The monitor can be restored to default settings, deleting all stored information, by holding down the "Connection" button and pressing and holding the [START/STOP] button for more than 2 seconds. This process will require re-pairing the monitor with a smart device for data transfer.

Maintenance Features

To ensure the longevity and accuracy of the monitor, proper maintenance is crucial. The manufacturer advises against disassembling or attempting to repair the monitor or its components, as this can lead to inaccurate readings and voids the user warranty.

The monitor should be stored in its storage case when not in use, in a clean and safe location. Avoid storing it in wet conditions, extreme temperatures, high humidity, direct sunlight, dust, corrosive vapors (like bleach), or areas exposed to vibrations or shocks.

For cleaning, abrasive or volatile cleaners should not be used. The monitor and wrist cuff should be cleaned with a soft dry cloth or a soft cloth moistened with neutral soap, followed by wiping with a dry cloth. Do not wash or immerse the monitor or wrist cuff in water, and avoid gasoline, thinners, or similar solvents.

The accuracy of the blood pressure monitor is carefully tested and designed for a long service life. It is generally recommended to have the unit inspected every two years to ensure correct functioning and accuracy. Users should consult their authorized OMRON dealer or customer service for calibration and service.

In case of error messages (e.g., "Er" for malfunction, "Err" for connection issues, "E1" for cuff inflation problems, "E3" for overinflated cuff, "E4" for movement during measurement, "E5" for pulse rate not detected), troubleshooting steps are provided. These include reapplying the cuff, remaining still, checking battery levels, and, if problems persist, contacting OMRON retail outlets or distributors.

The device also provides guidance on correct disposal of the product (Waste Electrical & Electronic Equipment) to prevent environmental harm and promote sustainable reuse of material resources. Household users are advised to contact retailers or local government offices for recycling details, while business users should consult their suppliers.

Omron RS3 Intelli IT Specifications