Microlife BP3GU1-8X User manual

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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 measur-
ing 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 oscillo-
metric method. 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 used in connection with your
personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA)
software; the memory data can be transferred to the PC by connecting the
monitor via cable with the PC.
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 circum-
stances 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

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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 measure-
ment.
•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 additonal injury.
Place and pressurize the Cuff over/near any present intravascular access
or therapy, or arteriovenous shunt, as this may cause blood flow interfer-
ence 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.

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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 batter-
ies.
•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.

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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
BHS
The B.H.S. (British Hypertension Society) clinical protocol was used to measure
the accuracy of this product. Blood pressure units using the same measurement
technology are graded “AA” for systolic/diastolic accuracy by independent
investigators using the BHS protocol. This is the highest grading available for
blood pressure monitors. Please see bhsoc.org for more information. (Uses the
same algorithm as B.H.S. graded “AA” model number 3BT0-1)
FCC
This device complies with part 15 of the FCC Rules. Operation is subject to
the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation. Changes or
modifications to the product are not approved by Microlife USA and could
void the user's authority to operate the equipment under FCC jurisdiction.

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This equipment has been verified 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 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 on and off,
the user is encouraged to try to correct the interference by increasing the
distance between the product and the affected device; or if applicable,
reorientation the receiving antenna, or moving the product’s power plug to
another receptacle.

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Automatic Blood Pressure Monitor
Instruction Manual–Table of contents
1. Introduction
1.1. Your automatic blood pressure monitor
2. How is blood pressure measured?
2.1. What is blood pressure, and why does it fluctuate?
2.2. Measurement guidelines
2.3. What can I do to change my blood pressure?
3. Components of your blood pressure monitor
4. How do I get started?
4.1. Inserting the batteries
4.2. Power switch
4.3. Setting the date and time
4.4. Using an AC power adapter
4.5. Connecting the cuff and monitor
4.6. Select the user
4.7. Select the measuring mode: standard or Microlife Averaging Mode
4.8. Microlife Averaging Mode
5. How do I take a measurement?
5.1. Preparing to take a measurement
5.2. Common errors
5.3. Using the cuff
5.4. Taking a measurement
5.5. Memory: reviewing readings
5.6. Stopping a measurement
5.7. Hypertension risk indicator
5.8. Irregular heartbeat detector
5.9. Battery change indicator
6. Software functions
6.1. Installation and data transmission
7. Error messages/troubleshooting
8. Care and maintenance
9. Limited warranty
10. Technical specifications
11. How to contact us

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1. Introduction
1.1. Your automatic blood pressure monitor
Your blood pressure monitor is a fully automatic digital blood pressure
measuring device for use by adults on the upper arm at home or in your
doctor’s office. It enables very fast and reliable measurement of the
systolic and diastolic blood pressure as well as the pulse by way of the
oscillometric method. This device offers clinically proven accuracy and has
been designed to be user friendly.
Before using your blood pressure monitor, please read this instruction
manual carefully and then keep it in a safe place for future reference. If
you have additional questions regarding blood pressure measurements
please contact your doctor.
2. How is blood pressure measured?
2.1. What is blood pressure, and why does it fluctuate?
Your level of blood pressure is determined in the circulatory center of the
brain and adjusts to a variety of situations through feedback from the
nervous system. To adjust blood pressure, the strength and frequency of
the heart (pulse), as well as the width of circulatory blood vessels is altered.
Blood vessel width is affected by fine muscles in the blood vessel walls.
Your level of arterial blood pressure changes periodically during heart
activity. During the "blood ejection" (Systole), the value is highest (systolic