HoMedics HL158B1-BD User manual

VER:A001 20220325U

Automatic

Wrist Blood Pressure Monitor

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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

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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