HEB inControl BP3NQ1-4BHEB User manual

Premium
Blood Pressure Monitor
with Bluetooth®Connectivity
Instruction Booklet for model# BP3NQ1-4BHEB

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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 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. This device detects the appear-
ance of irregular heartbeats during measurement and provides a warning signal when
the irregular heartbeat is detected.
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 inde-
pendently 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

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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. spo-
radic 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 equip-
ment 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 pro-
longed/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 appli-
cable) 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 accu-
racy. Move the device to another location if interference is determined.
•When not using the Blood Pressure Monitor for extended lengths of time, remove

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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 poten-
tial 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 deter-
mine 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 humid-
ity 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 pres-
sure 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.