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1. 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.
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
Intended Purpose
This device is a digital monitor intended for use in measuring blood pressure and
pulse rate in adult patient population. The device can detect an irregular pulse
suggestive of Atrial Fibrillation (AFib). Please note that the device is not intended
to diagnose AFib. A diagnosis of AFib can only be confirmed by a physician
with an Electrocardiogram (ECG). If the AFib symbol appears, consult with your
physician.
Intended Patients
Adult patient population
Intended Users
Adult population who can understand this instruction manual.
Clinical Benefit
Patient’s blood pressure can be measured non-invasively and simply in the
home environment, and the possibility of AFib is detected from the pulse wave
obtained from the blood pressure measurement and provided to the user.
Type of Use
This monitor is intended to be multiple patient multiple use.
Limitation
Patient’s arm circumference must be 22 -42cm.
Indication
This device is used by healthy individuals, patients with hypertension, patients
with health-conscious individuals, in a general household situation for the
following purpose.
- measure blood pressure and pulse rate
- evaluate the possibility of AFib
1.3 Receiving and Inspection
Remove this monitor and other components from the packaging and inspect
for damage. If this monitor or any other components is damaged, DO NOT USE
and consult with your OMRON retail outlet or distributor.
2. Important Safety Information
Read the Important Safety Information in this instruction manual before using
this monitor. Follow this instruction manual thoroughly for your safety.
Keep for future reference. For specific information about your own blood
pressure, consult with your physician.
2.1 Contraindications
R DO NOT use this monitor on an injured arm or an arm under medical
treatment.
R DO NOT apply the arm cuff on your arm while on an intravenous drip or
blood transfusion.
R DO NOT use this monitor on infants, toddlers, children or persons who
cannot express themselves.
2.2 Side Eects
R Taking measurements more often than necessary may cause bruising due to
blood flow interference.
R 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 section10 of instruction manual 2 for additional
information.
R Stop using this monitor and consult with your physician if you experience
skin irritation or discomfort.
2.3 Warning
Indicates a potentially hazardous situation
which, if not avoided, could result in death or
serious injury.
R DO NOT adjust medication (including altering your use of any drug or
treatment) 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 and heart related conditions.
R NEVER diagnose or treat yourself based on your readings. ALWAYS consult
with your physician.
R The possible AFib screening feature evaluates for a possibility of AFib ONLY.
It will NOT detect other potentially life-threatening arrhythmias or diseases,
such as a possibility of other cardiac arrhythmias or heart attack.
R If you are experiencing any symptoms or concerns, consult with your
physician.
R DO NOT postpone/stop regular
checkups or physician visits based on the
results that you are getting from this monitor.
R The possible AFib screening feature is not intended to be used for the users
who have already been diagnosed with AFib.
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