HoMedics HL158B1-BD User manual

VER:A001 20220325U
I
In ns st tr ru uc ct ti io on n M Ma an nu ua al l
Automatic
Wrist Blood Pressure Monitor
M
Mo od de el l N No o. . H HL L1 15 58 8B B1 1- -B BD D
B
BP PW W- -8 80 00 0B BT T- -W WT T

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Table of Contents
Medical Disclaimer .......................................................................... 2
Intended Use ................................................................................. 2
About Blood Pressure ...................................................................... 3
Measurement Method ..................................................................... 5
Accuracy ....................................................................................... 6
Precautions ................................................................................... 7
De ice O er iew ............................................................................ 9
Symbol Definitions ....................................................................... 11
Features ..................................................................................... 12
Bluetooth Transmission ................................................................. 15
Installing Batteries ....................................................................... 17
Applying the Cuff ......................................................................... 18
Positioning Guide ......................................................................... 19
Measurement Procedure ................................................................ 20
Memory Function ......................................................................... 23
Storage and Maintenance .............................................................. 25
Troubleshooting ........................................................................... 27
Warranty & Recalibration ............................................................... 29
Specifications .............................................................................. 30
Note .......................................................................................... 31
Appendix .................................................................................... 33
Blood Pressure Diary .................................................................... 36

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Medical Disclaimer
This manual and product are not meant as a substitute for ad ice
pro ided by your doctor.
You are not to use the information contained herein, or this product
for diagnosing or treating a health problem or prescribing any
medication. If you ha e or suspect that you ha e a medical problem,
promptly consult your healthcare pro ider.
ntended Use
This de ice automatically measures human’s Systolic, Diastolic blood
pressure and heart rate by using the oscillometric method during
deflation. All alues can be read out in one LCD panel. Measurement
position is at human being’s wrist. The intended use of this
o er-the-counter de ice is for adults aged 18 years and older with
wrist circumference ranging from 5.3 inches to 7.7 inches (approx.
135 mm to 195 mm) and for home use.
HL158B1-BD detects the appearance of irregular heartbeats during
measurement; an indicated symbol will appear with measuring
reading. And the Risk Category Indicator will show the information
with the readings on the screen for the user tracking their blood
pressure le el.
Besides, the de ice features a built-in "Bluetooth Data Transmission"
function, which enables the de ice automatically transmit measuring
results to paired Bluetooth-enabled de ice. Also, users could simply
synchronize the current date and time, and check the battery status
of blood pressure monitor by means of DailyChek
®
application
software with the paired Bluetooth-enabled de ice.
Additionally, the Wrist Position Guide is used as an aid in determining
if the de ice is at correct position in relationship to the heart.

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1. What is Blood Pressure?
Blood pressure is the measurement of the force of blood pushing
against the walls of the arteries. Arterial blood pressure is
constantly fluctuating during the course of the cardiac cycle. The
highest pressure in the cycle is called the systolic blood pressure,
and represents the pressure in the artery when the heart is beating.
The lowest pressure is the diastolic blood pressure, and represents
the pressure in the artery when the heart is at rest. Both the
systolic and the diastolic pressure are necessary for a physician to
e aluate the status of a patient's blood pressure.
Many factors such as physical acti ity, anxiety or the time of day,
can influence your blood pressure. Blood pressure is typically low
in the mornings and increases from the afternoon to the e ening.
It is on a erage lower in the summer and higher in the winter.
2. Why Is It Useful to Measure Blood
Pressure at Home?
Ha ing one's blood pressure measured by a doctor in a hospital or
a clinic, is often associated with a phenomenon called “White Coat
Hypertension” where the patient becomes ner ous or anxious,
thus raising his blood pressure. There are also numerous other
factors that might cause your blood pressure to be raised at a
specific time of day. This is why medical practitioners recommend
home monitoring as it is important to get readings of blood
pressure during different times of the day to really get an idea of
your real blood pressure.
Medical practitioners generally recommend the “Rule of 3”, where
you are encouraged to take your blood pressure three times in a
row (at 3 ~ 5 minute inter al), three times a day for three days.
After three days you can a erage all the results and this will gi e
you an accurate idea of what your blood pressure really is.
About Blood Pressure

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About Blood Pressure
A. AHA Blood Pressure Classifications:
Standards for assessment of high or low blood pressure without
regard to age, ha e been established by the American Heart
Association (AHA 2017), as shown in the chart.
Howe er, this chart is not exact for classification of blood
pressure and it's intended to be used as a guide in understanding
non-in asi e blood pressure measurements. Please consult with
your physician for proper diagnosis.
B. Variations in Blood Pressure:
Indi idual blood pressures ary greatly both on a daily and a
seasonal basis. These ariations are e en more pronounced in
hyper tense patients. Normally the blood pressure rises while at
work and is at its lowest during sleeping period.
(Hyper-tense means a person who has high blood pressure
symptom.)
The graph below illustrated the ariations in blood pressure o er
a whole day with measurement taken e ery fi e minutes.
The thick line represents sleep. The rise in blood pressure at 4 PM
(A in the graph) and 12 AM (B in the graph) correspond to an
attack of pain.
BLOOD PRESSURE CATEGORY SYSTOLIC mmHg
(Upper Number)
DIASTOLIC
mmHg
(Lower Number)
HYPERTENSIVE CRISIS
(co sult your doctor immediately)
HIGHER THAN 180 AND/OR
HIGHER THAN
120
HIGH BLOOD PRESSURE
(HPERTENSION STAGE 2) 140 or HIGHER OR 90 or HIGHER
HIGH BLOOD PRESSURE
(HYPERTENSION STAGE 1) 130 ~ 139 OR 80 ~ 89
ELEVATED 120 ~ 129 AND LESS THAN 80
NORMAL LESS THAN 120 AND LESS THAN 80
(Direct
arterial
pressure
recording
in
unrestricted
man.
Be en, Honour & Stott: Clin. Sci. 36:329. 1969)

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HL158B1-BD Automatic Wrist Blood Pressure Monitor measures
blood pressure and heart rate by oscillometric method, meaning the
fluctuations in pressure are measured. Once the cuff is wrapped
around your wrist, just turn on the monitor and inflation
automatically starts. The inflation of the cuff creates pressure around
the arteries inside the wrist.
Within the cuff is a gauge which senses the fluctuations (oscillations)
in pressure. The fluctuation measured represents the degree of
intensity that your arteries contracting with each heartbeat, and also
a result of the pressure that the cuff has placed on the wrist. The
monitor measures these contractions and con erts the information to
a digital alue. This is the result displayed on the monitor screen.
Once the measurement is complete, the cuff will automatically
deflate.
Note!
* The patient is an intended operator.
Measurement Method

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HL158B1-BD Automatic Wrist Blood Pressure Monitor has been
clinically tested against a scientific de ice called a mercury
sphygmomanometer, considered the gold standard in blood pressure
measurement.
All HL158B1-BD Automatic Wrist Blood Pressure Monitors ha e
performed equi alent to measurements taken with this scientific
de ice and are within the accuracy limits prescribed by the American
National Standard for Electronic or Automated
Sphygmomanometers.
The SPHYGMOMANOMETER was clinically in estigated according to
the requirements of ISO 81060-2:2018.
* n case it is needed to have the device checked for
calibration, please consult the distributor.
Accuracy

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 The de ice should not be used to either self-diagnose
Hypertension or exclude the diagnosis of Hypertension. If your
blood pressure reading is out of normal range, please consult your
physician. E en your blood pressure reading is within the "normal"
range, the de ice cannot exclude the diagnosis of Hypertension.
 Do not take a measurement in a low (less than 41˚F / 5˚C) and
high (more than 104˚F/ 40˚C) temperature, nor in a place outside
humidity ranges (15 % ~ 93 % R.H.), and atmospheric pressure
ranges (700 ~ 1060 hPa), or you may get inaccurate readings.
 Wait 30 ~ 45 minutes before measurement if you’ e just
consumed caffeinated be erages or smoked cigarettes.
 Rest at least 5 ~ 10 minutes before taking a measurement.
 To allow your blood essels to return to the condition prior to
taking the measurement, please wait at least 3 ~ 5 minutes in
between measurements. You may need to adjust the wait time
according to your personal physiological situation.
 We recommend you using the same wrist (preferably the left wrist)
and measuring around the same time each day.
 Perform measurements in a quiet and relaxed en ironment at
room temperature.
 Do not mo e or shake the de ice during a measurement. Please
keep quiet and do not talk during measurements.
 The de ice has no any interface to pro ide updates/upgrades and
therefore de ice is no security ulnerabilities.
Precautions
* Read the Instruction Manual thoroughly before measuring and
keep it at hand for your reference at any time.
* The de ice is designed for home use and not suitable for clinical
use.
* The patient is an intended operator, who can operate the de ice
by himself or herself, not necessarily by a physician or operator.
* This monitor is not intended for use in the MR en ironment.

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Precautions
 This product is not suitable for:
 Pregnant women
 People with arrhythmias
 Undergoing intra enous injection on any limb
 Currently in a dialysis treatment
 In pre-eclampsia condition
 For those who ha e had a mastectomy or lymph node clearance, it
is recommended to take a measurement on the unaffected side.
 When used among medical electronic equipment on the same limb,
pressurization of the cuff may cause temporarily malfunction to
other de ices.
 If you ha e one of the circulatory problems as arteriosclerosis,
diabetes, li er disease, kidney disease, se ere hypertension,
peripheral circulation……, please consult your healthcare
professional before using the de ice.
 Blood pressure measurements taken with this de ice are
equi alent to those obtained by a trained obser er using the cuff /
stethoscope auscultation method and are within the accuracy
limits prescribed by the Standard of EN 1060-4.
 The applied part is cuff.
*Attention !
1) Do not use the de ice on infants, children, or those who cannot express their own intention.
2) The medical de ice should not be used adjacent to or stacked with other equipment. When
the blood pressure monitor are used in a high le el radio frequency electromagnetic fields
(e.g. close to the wireless communication equipment), it may lose or degrade essential
performance, such as de ice gi ing the error code, de iated readings, or malfunction.
3) Consider the electromagnetic compatibility of the de ice (ex. power disturbance, radio
frequency interference etc.) Please use it indoor only.
4) O er high frequency measurements may result in blood flow interference, which is likely to
cause uncomfortable sensations, such as partial subcutaneous hemorrhage, or temporary
numbness to your wrist. In general, these symptoms should not last long. Howe er, if you
do not reco er in time, please seek your medical practitioners for help.

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 Product Components
Device Overview
LCD D
isplay
Start/Stop
Button
AAA “
LR03
”
(1.5V)
Alkaline Battery X 2
Mode Button
Memory/
Bluetooth
Button
Set/User
Button
Risk Category
Indicator
Storage Case
Wrist Cuff

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Device Overview
 Unit Display
Hour：Minute
(Also Represents Year in Setting Mode)
Heart Rate
Low Batt
ery Symbol
User Number
Pulse Symbol
Risk Category
Indicator Bar
A erage of Last 3
Measurements
Systolic Pressure
Diastolic Pressure
Month/Date
Irregular
Heartbeat Detector
1. Excessi e Body Motion
Detector
2. Cuff Fitness Detection
AM/PM Last 3
A eraging
Bluetooth Symbol
Wrist Position
Guide

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SYMBOLS Definitions
Low Battery Symbol
This symbol appears when the b
attery power is excessi ely low or the
polarity re erses.
 We suggest you replace all batteries with new ones, and make sure
the +/- polarities are properly positioned.
Pulse Symbol
Once pulse is detected, the symbol flashes with each pulse beat.

Our suggestion:
Please do not talk or mo e during measurements.
Irregular Heartbeat Detector
This symbol appears when an irregular heart beat was detected.
 Our suggestion:
Repeat the measurement after resting for at least 5 minutes, and
restart your measurement while sitting down comfortably and
quietly. If symbols appear frequently, please contact your physician.
Excessi e Body Motion
Detector
Displayed if body mo ement is detected during measurement,
especially, the mo ement
on the wrist the blood pressure monitor is
worn on. Besides, if cuff is worn improperly, or the shape of the wrist
is unusual, excessi e gap might exist between the wrist cuff and the
wrist.
Notice: The measured blood pressure reading may not be accurate i
f
the icon is displayed.
Cuff Fitness
Detection Symbol
Displayed if the cuff was wrapped incorrectly, which is too tight or too
loose. This is the function aid in detecting if the cuff is wrapped
properly.
Wrist Position Guide
T
he Wrist Position Guide is used as an aid in determining if the de ice
is at the appropriate angle and height.
Bluetooth Symbol
LCD displays this symbol when Bluetooth is acti e.
AM/ PM Averaging: Indicates the reading being display
ed is an
a erage from the last 3 morning or last 3 e ening measurements.
Risk Category Indicator
Bar
The arrowhead points out the specific Risk
Category that your
measurement reading fits in.
A erage of Last 3
Measurements
This symbol appears when
LCD displays a erage alue of last 3
readings.
User 1: Appears when the monitor is operated by User 1.
User 2: Appears when the monitor is operated by User 2.
Symbol Definitions

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 Risk Category Indicator (AHA 2017)
This de ice is equipped with Risk Category Indicator which classifies your
blood pressure measurements into fi e stages (Normal, Ele ated,
Hypertension stage 1, Hypertension stage 2 and Hypertensi e crisis)
based on the blood pressure standards established by the American Heart
Association (AHA). Besides, for yours and your lo ed ones’ health, we
further classify the fi e stages into numeral ranges, which sorts out
hypertension symptoms more clearly. Moreo er, to your con enience and
readability, we use three corresponding colors to represent your
measuring result. Refer to below comparison chart for details:
*Source: AHA, 2017
After measurement, LCD displays the systolic and diastolic pressure, heart
rate, date and time along with Risk Category Indicator bar. The higher the
blood pressure, the higher the bar. Compare the bar with the three colors at
the right of LCD display to know the classification of your blood pressure
based on American Heart Association standard (AHA 2017).
*Note
！
When a person’s systolic and diastolic pressures fall into different categories, the higher category
should apply.
e.g. systolic Pressure 181 & diastolic pressure 99  Red category (Hypertensi e crisis)
e.g. systolic Pressure 110 & diastolic Pressure 95  Red category (Hypertension stage 2)
*Note !
The abo e table is not exact for classification of blood pressure and it's intended to be used as a
guide in understanding non-in asi e blood pressure measurements.
Usually this is not a cause for concern; howe er we recommend you consult with your physician for
proper diagnosis or seek medical ad ice according to our recommendation mentioned abo e. Please
note that the de ice does not appropriate to diagnose hypertension, and it is only for user reference
on blood pressure monitoring.
Features
BLOOD PRESSURE
CATEGORY
SYSTOLIC mmHg
(Upper Number)
DIASTOLIC
mmHg
(Lower Number)
INDICATOR
COLOR
HYPERTENSIVE CRISIS
(consult your doctor immediately)
>18 AND/OR >12
Red
HIGH BLOOD PRESSURE
(HPERTENSION STAGE 2) 14 ~ 18 OR 9 ~ 12
HIGH BLOOD PRESSURE
(HYPERTENSION STAGE 1)
13 ~ 139 OR 8 ~ 89
ELEVATED 12 ~ 129 AND < 8 Yellow
NORMAL < 12 AND < 8 Green

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Features
 Irregular Heartbeat Detector
The symbol will appear on screen indicating a certain
heartbeat irregularity was detected during measurement.
The heartbeat rhythm that is more than or less than 25% from the
a erage rhythm is usually defined as an irregular heartbeat rhythm.
Talking, mo ing, shaking or an irregular pulse during the
measurement can result in the appearance of this symbol.
Usually this is not a cause for concern, howe er if the symbol
appears often, we recommend you seek medical ad ice.
And please note that the de ice does not replace a cardiac
examination, but ser es to detect pulse irregularities at an early
stage.
*Note
！
 The pulse display is not suitable for checking the frequency of heart
pacemakers. If a certain pulse irregularity is detected during measurement
often, we recommend you seek medical ad ice
 As a safeguard, we recommend that if you ha e arrhythmias such as atrial or
entricular premature beats and atrial fibrillation or any other special
conditions you should check with your physician before using your de ice.
 The IHB function is not designed for use by people with arrhythmias nor for
diagnosing or treating an arrhythmic problem. In order to filter the unstable
status of user and a oid affecting the detection of heart rate from any
mo ement, shaking or talking in the beginning of measurement, the method of
a eraging heart beat inter als of subject de ice is calculated with the three
proper heart beat pulses detected in the beginning of measurement and that is
different from a strict mathematical a eraging of all recorded inter als.
 At least 3 beats with at least 25 % difference from the a erage heart beat
inter al will generate the IHB icon on the screen.

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Features
HL158B1-BD has a built-in Wrist Position Guide function used as an
aid to help user determining if the de ice is at appropriate height.
 Turning Wrist Position Guide ON/OFF
This function default setting is on. User can switch the function ON
and OFF. Under standby mode, users can press button, the
de ice will enter to set year, date, month, hour, minute and
Bluetooth function first. When these setting are done, press the
button again, use button to switch the Wrist Position Guide
function ON and OFF.
 Wrist Position Guide
After you press START/STOP button, the display will illuminate
with different icons that are designed to guide you mo e your
wrist. Once the appropriate height is detected, the Pulse ( )
Symbol will flash with beep sound for 3 times and measurement
will begin.
SYMBOL ACT ON
UP Mo e your wrist up.
DOWN Mo e your wrist down.
*Note!
This Wrist Position Guide is only for reference on blood pressure measurement. Due to
difference in indi idual size, physique, and being dependent on the height of the table and
desk, in addition to the position of the hand in comparison to the horizontal plane of reference
and the heart, this feature may not helpful in all cases. If you feel the position of the wrist
according to Wrist Position Guide does NOT match your heart le el, you can select to turn this
feature off and consult your healthcare pro ider.

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HL158B1-BD features a Bluetooth transmission function, which enables
the de ice automatically transmit measured results to paired
Bluetooth-enabled de ice after measurement. When connection
established, the de ice would transmit, systolic pressure, diastolic
pressure, and pulse with time to the Bluetooth enabled de ice.
Before attempting to sync the de ice with your smart de ice, make sure
Bluetooth function is turned ON in both your smart de ice and the monitor,
and make sure your Bluetooth-enabled de ice ha e downloaded the App.
See the “App for Bluetooth” section for details.
◆ Turn the Bluetooth Function ON/OFF
This function default setting is on. Under standby mode, user can
switch the function ON or OFF. By pressing button, the de ice will
enter to setting year, date, and time first. When these setting are
done, press the button again, use button to turn Bluetooth
function ON or OFF.
Bluetooth function is ON Bluetooth function is OFF
◆ Transmit Readings
1. There are 2 ways to acti ate Bluetooth function.
a. Automatically Activate:
When measurement completed, the de ice acti ates Bluetooth
function automatically, and Bluetooth symbol will flash on
the screen.
b. Manually Activate:
Under standby mode, user can press and hold the button for
3 seconds to acti ate Bluetooth function, and Bluetooth symbol
will flash on the screen.
Bluetooth Transmission
Press

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Bluetooth Transmission
2. If HL158B1-BD is connected successfully to your smart de ice,
Bluetooth symbol will appear on the screen.
3. If the monitor cannot be connected to paired Bluetooth-enabled
de ice o er 45 seconds, LCD will display Error message “E4” and
Bluetooth will be turned off.
 App for Bluetooth
Download and install “DailyChek
®
” app on your smart de ice from
Google Play or App store.
System requirement of the Bluetooth-enabled de ice
□ Bluetooth 4.2 for Android 6.0 or abo e
□ Bluetooth 4.2 for iOS 7.0 or abo e
NOTE:
 HL158B1-BD is subject to and complies with electromagnetic compatibility
(EMC) standard of EN 60601-1-2, EN 301 489-1, EN 301 489-17, EN 300
328 and U.S. federal guidelines, Part 15 of the FCC (Federal
Communications Commission) rules for de ices with RF capability. These
guidelines help ensure that your de ice will not affect the operation of
other nearby de ices. Additionally, other de ices should not affect the use
of your de ice.
 Other wireless de ices that are in use nearby, such as a cell or mobile
phone, or a wireless network, may pre ent or delay the transmission of
data from your de ice to paired Bluetooth de ice. Mo ing away from the
source of the interference or turning off these de ices to resol e the
problem.
 Make sure HL158B1-BD and paired Bluetooth de ice are within acceptable
distance (no more than 10 meters) with each other. If not, put them closer.
 Be sure to select the correct User on the monitor before your blood
pressure measurement begins.
 Bluetooth date transmission is not a ailable under measurement.
About Bluetooth Data Transmission Function
The Bluetooth data transmission function might not be workable to some
Bluetooth-enabled de ices because of the compatibility of Android system.
Some issues that the Bluetooth implementations on these de ices ha e unresol ed
errors. It is not because of the Bluetooth module in monitor is not supported.

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When LOW BATTERY SYMBOL appears on the display, or no
reaction toward operation, please change batteries.
Replace all worn-out batteries with new ones and do not mix new and
used batteries. Do not mix alkaline, standard (carbon-zinc) or
rechargeable (cadmium) batteries either. Such action may shorten
the battery life or cause the de ice to malfunction.
All batteries used must be the same type.
Slide the battery co er, prepare 2 AAA (1.5V, LR03) alkaline batteries.
Insert one battery on the outside first, and then insert another inside
as shown on the figure below. Please make sure the polarities “+” and
“–” ends are coinciding with similar markings engra ed on the battery
housing.
*Attention
！
 Batteries are hazardous waste. Do not dispose of them together with the
household garbage. Please discard worn-out batteries to the recycling site
according to local regulations.
 Keep the battery away from children in case they choke on it.
 To prolong the battery life and pre ent damage caused by leakage, remo e
the batteries from the de ice if the de ice is not to be used for a long period.
 Replacing batteries clear all stored memory.
 After replacing the batteries, reset date and time.
nstalling Batteries

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 Do not place the pressure cuff o er a jacket or
sweater slee e. Wrap the pressure cuff around the
bare wrist with the monitor facing you.
 Wrap the cuff snugly. Do not make it too tight.
 Fold the remaining part of the cuff back out of the way.
 Lea e approximately 0.4 inch (10 mm) between the
cuff and the bottom of your hand palm.
*Note
！
 Do not use this de ice if your wrist has any wound or injury.
 Do not wrap the cuff around any body part other than your wrist.
 In case the cuff kept pumping up non-stop, unwrap the cuff at once.
 If you ha e any infectious skin disease or the de ice is used by users with
infectious skin disease, please do not continue using the de ice.
 Before using the de ice, user should check the appearance of cuff. If you
notice blood or other soil on cuff, please do not use this de ice.
 If there is one of abo e situations, please dispose the de ice without
reuse.
 Do not use this de ice if your wrist has any wound or injury, especially
after surgery on the wrist. Otherwise, it may cause infection at the
surgical site. Please use the de ice after the wound has healed.
Applying the Cuff
0.4 inch (10 mm)
5.3 ~ 7.7 inch (135 ~ 195 mm)

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It is extremely important that the cuff be at the same height as the
heart.
Ha ing the cuff higher or lower may cause inaccurate results.
1. Sit on a chair comfortably, put your feet
flat on the floor and lay your forearm on
the table, make sure your back and arm
supported, legs uncrossed.
2. Position the blood pressure monitor on
your wrist.
3. Place your elbow on the table and rest
the back of your hand on the de ice
storage case or other object.
4. Rest your wrist on the armrest until it’s
at the same height as your heart.
5. Relax your hand and turn your palm upwards.
6. This Wrist Position Guide is only for reference on blood pressure
measurement. Due to difference in indi idual size, physique, and
being dependent on the height of the table and desk, in addition to
the position of the hand in comparison to the horizontal plane of
reference and the heart, this feature may not helpful in all cases. If
you feel the position of the wrist according to Wrist Position Guide
does NOT match your heart le el, you can select to turn this feature
off and consult your healthcare pro ider.
Positioning Guide