INSTR UCTION MANUAL
Premium
Blood
Pressure
Monitor
Model # BP3 GY1 -2N
QUE S TION S ? 1 -8 0 0 -56 8 -4 14 7
Important Product and Safety Information
Follow Instructions for Use. This document provides
important product operation and safety information regarding
this Blood Pressure Monitor. Please read this document
thoroughly before using the device and keep for future
reference.
This blood pressure monitor is an automatic digital blood pressure measuring device for use by adults, on the upper arm at home or in the doctor’s
office. It enables a very fast and reliable measurement of the systolic and
diastolic blood pressure, as well as the pulse rate, by way of the oscillometric method during cuff inflation. This device detects the appearance of
irregular heartbeats during measurement and provides a warning signal
when the irregular heartbeat is detected. The device can be connected via
Bluetooth to a smart mobile device running the App.
This blood pressure monitor IS intended to be used:
•
For self-measurement/monitoring of blood pressure and pulse in adults;
whereas the person being measured may be the user/operator of the
device.
•
Within a home healthcare environment.
•
With a cuff located upon the user’s upper arm; ½ inch above the elbow
over the artery as indicated on the cuff.
This blood pressure monitor IS NOT intended for use with:
•
Pregnancy
•
Preeclampsia
•
Children under 12
•
Neonatal patients
WARNING – Potentially hazardous situation that if not
avoided may result in serious injury or death.
•
Self-measuring means monitoring, not diagnosis or treatment. Unusual
values must always be discussed with your doctor. Under no circumstances should you independently alter the dosages of any drugs
prescribed by your physician.
•
Consult your physician before using this device if any of the following or
similar conditions are present: arrhythmias such as atrial or ventricular
premature beats or atrial fibrillation, arterial sclerosis, poor perfusion,
diabetes, age, pregnancy, preeclampsia, renal diseases. Motion during
measurement, including trembling or shivering may affect the measurement.
•
Though not for use with children under 12, ensure that any children
around this device are supervised; some parts are small enough to be
swallowed and any present tubes or cables may provide a risk of
strangulation.
•
Ensure the cuff tubing is not kinked during use as harmful injury may
occur due to the effect of blood flow interference caused by high pressure
in the cuff not releasing.
DO NOT:
Use this device if you think it is damaged or anything appears unusual
(e.g. sporadic operation, open packaging upon purchase).
Use the displayed pulse for checking the frequency of heart pacemakers
as this device is not suitable for this action.
Open/modify this device; inaccuracy and/or harmful injury may result.
Conduct many frequent measurements as this may result in harmful
injury due to blood flow interference.
Place the Cuff over a wound as this may cause further injury.
Place and pressurize the Cuff over/near any present intravascular access
or therapy, or arteriovenous shunt, as this may cause blood flow interference and result in harmful injury.
Place and pressurize the Cuff over a limb near the side of a mastectomy
as this may cause harmful injury.
Use the Blood Pressure Monitor on a limb simultaneously with other medical
equipment on the same limb due to possible interference with such medical
equipment.
Maintain pressure in the Cuff applied to the limb for a prolonged amount
of time. Ensure that circulation in the limb is not impaired by checking
circulation if prolonged/repeated exposure to pressure occurs.
Service the device when being used or when power is supplied. When
the device is not in use and power is removed, cuff assembly, batteries
and ac adapter (if applicable) may be replaced by the user with Microlife
supplied replacements. No other parts/components are accessible.
CAUTION – Potentially hazardous situation that if not avoided
may result in minor/moderate injury, property damage, and/or
damage to the device
•
This device contains sensitive electronics components. Avoid strong
electrical or electromagnetic fields in the direct vicinity of the device
(e.g., mobile telephones, microwave ovens). These can lead to temporary
impairment of the measuring accuracy. Move the device to another
location if interference is determined.
• When not using the Blood Pressure Monitor for extended lengths of
time, remove the batteries to avoid potential battery leakage and
damage to the monitor.
• When replacing the batteries, ensure all the batteries are replaced
simultaneously to avoid battery damage and potential damage to the
monitor. Microlife USA does not recommend using rechargeable batteries.
• To avoid inaccurate measurements and to lessen any discomfort from
Cuff pressure, ensure the Cuff is placed correctly on the limb and fits
correctly when snug (not tight), as indicated by markings with the Cuff.
• Consult your physician in cases of frequent irregular heartbeat
detections.
• This Risk Indicator feature is provided in order to help you understand
your potential blood pressure risk. However, this feature is neither a
diagnosis nor a substitute for a medical examination. It is important to
consult with your physician to determine your risk.
DO NOT:
Drop this device or expose it to strong vibrations; sensitive components
may be affected resulting in inaccuracies and/or operational issues.
Use the Blood Pressure Monitor outside of its specified operation
temperature and humidity rating, or if stored outside of its specified
storage temperature and humidity rating. Avoid storage in direct
sunlight.
Use this device in a moving vehicle; inaccurate measurements may
result.
Use third party accessories. Only use Microlife authorized accessories,
such as cuffs or AC adapters, as those not approved for use with the
device may provide inaccurate measurements, injury, and/or damage the
device.
STANDARDS
In addition to the standards stated in the Instruction Manual:
•
This medical device is compliant with medical device and non-invasive
blood pressure monitor standards IEC 60601-1, IEC 60601-1-2, IEC
60601-1-11, and AAMI/ANSI/IEC 80601-2-30, and
•
Electromagnetic standards IEC 60601—1-2 along with FCC Part 15, and
•
Clinical Testing per standard ISO 81060-2:2013 was conducted on blood
pressure device using the same measurement technology.
Please note: According to international standards, your monitor should be
checked for accuracy every 2 years.
TYPE
IP20
Protected against solid foreign particles with a diameter of more
than 12.5 mm, no protection against water. Keep Dry.
Type BF Applied Part
Batteries and electronic instruments must be disposed of in accordance
with the locally applicable regulations, not with domestic waste.
Expected Life
Monitor
5 Years
Cuff
2 Years
Trademark Usage:
Apple, the Apple logo, iPad, and iPhone are trademarks of Apple Inc.,
registered in the U.S. and other countries. App Store is a service mark of
Apple Inc.
Android and Google Play are both trademarks of Google Inc.
The Bluetooth® Smart word mark and logos are registered trademarks
owned by Bluetooth SIG, Inc. and any use of such marks in this Blood
Pressure Monitor is under license. Other trademarks and trade names are
those of their respective owners.
Federal Communications Commission (FCC) Statement
15.21
You are cautioned that changes or modifications not expressly approved by
the part responsible for compliance could void the user’s authority to
operate the equipment.
15.105(b)
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation.
This equipment generates uses and can radiate radio frequency energy and,
if not installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception,
which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the
following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.
This device complies with part 15 of the FCC Rules. Operation is subject to
the following two
conditions:
1) this device may not cause interference and
2) this device must accept any interference, including interference that may
cause undesired operation of the device.
Premium Automatic Blood Pressure Monitor
Instruction Manual
Table of Contents
1.
Introduction
1.1. Your automatic blood pressure monitor
1.2. Diabetes validation
2.
Components of your blood pressure monitor
2.1. Blood pressure monitor
2.2. Blood pressure cuff
3.
How do I get started?
3.1. Screen film
3.2. Inserting the batteries
3.3. Power switch / screen lock
3.4. Using the interactive touch screen
3.5. Setting the date and time
3.6. Select the user
3.7. Select the measuring mode: standard or Microlife Averaging Mode
3.8. Microlife Averaging Mode
3.9. Connecting the cuff and monitor
3.10.Using the AC power adapter
4.
How do I take a measurement?
4.1. Preparing to take a measurement
4.2. Common errors
4.3. Using the cuff
4.4. Taking a measurement
4.5. Memory: Reviewing readings
4.6. Stopping a measurement
4.7. Hypertension risk indicator
4.8. Irregular heartbeat detector
4.9. Battery change indicator
5.
Bluetooth functions and application (App)
5.1. Bluetooth® icon indicator (on monitor)
5.2. iOS devices
5.3. Android OS Phones
6.
Error messages/troubleshooting
7. How is blood pressure measured?
7.1. What is blood pressure, and why does it fluctuate?
7.2. Measurement Guidelines
7.3. What can I do to change my blood pressure?
8. Care and maintenance
9. Limited warranty
10. Technical specifications
11. How to contact us
1. Introduction
1.1. Your Automatic Blood Pressure Monitor
Thank you for purchasing a fully automatic blood pressure monitor. Your
monitor is designed to provide fast and reliable digital readings of your
pulse, and systolic / diastolic blood pressure using the oscillometric method
on your upper arm. It offers clinically proven accuracy and has been
designed to be user friendly.
If you have additional questions regarding blood pressure measurements
please contact Microlife Customer Service at 1-800-568-4147 or contact
your doctor.
1.2. Diabetes validation
Microlife’s commitment to disease-state management has led to our
clinical validation for use with diabetes. This is a worldwide first that
reinforces our commitment to quality, accuracy and meaningful innovation.
2.
Components of your blood pressure monitor
2.1. Measuring unit
Cuff Socket
(yellow)
Hypertension
Risk Indicator
Memory
Date/Time
User Switch
Start, Stop,
Enter
AC Adapter Port
MAM mode
switch
Select 1 or 3
Measur ements
Power, Screen Lock
2.2. Wide Range Cuff:
For arm circumference 8.7” - 16.5” (22 cm - 42 cm)
If you ever need to buy a replacement cuff, call
us toll-free at 1-800-568-4147.
Anti-Slip Cuff:
Your wide range cuff is equipped anti-slip grips
that ease the process of correctly positioning the
cuff on your arm.
Cuff Sizing:
The proper fit is essential for accurate blood
pressure readings. The average arm circumference
for a woman is 11", and the average for a man is
13". This cuff can accommodate arm circumferences
from 8.7" to 16.5" and fits most adults.
Arm circumference should be measured with a
measuring tape in the middle of the relaxed upper
arm. If the cuff is too small, call 1-800-568-4147 for
additional information.
Note:
• Do not force cuff connection into the opening.
• Make sure the cuff connection is not pushed into
the AC adapter port.
18”
16”
13”
12”
9”