equate HL858CE User manual

1
Instruction Manual
Automatic
Upper Arm Blood Pressure Monitor
Model No. HL858CE
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2
Table of Contents
Medical Disclaimer……………………………………………………………………………03
Intended Use………………………………………………………………………………..…03
About Blood Pressure………………………………………………………………………04
Measurement Method…………....……………………………………………………06
Accuracy……………………….…………………………………………………………………07
Precautions………………….…………………………………………………….…………….. 08
Device Overview……………………………………………………………………………….10
Symbol Definitions………………………………………………………………………….13
Features………………………………………………………………………………………….14
Installing Batteries………………………………………………………………………….21
Using the AC/DC adapter…………………………………………………………………22
Applying the Cuff…………………………………………………………………………….23
Measurement Procedure………….…………………………………………………….24
Bluetooth Transmission………………………………………………………………………29
Memory Function…………………………………………………………………………….31
Storage and Maintenance……………………………………………………………….34
Troubleshooting……………………………………………………………………………….35
Warranty………………………………………….……………………………………………….36
Specifications………………………………………………………………………………….37
Note………………………………………………………………………………………….…….39
Appendix…………………………………………………………………………………….…….41
Blood Pressure Diary……………….……………………………………………….…….43
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3
Medical Disclaimer
This manual and product are not meant as a substitute for advice
provided 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 have or suspect that you have a medical problem, promptly
consult your healthcare provider.
Intended Use
HL858CE automatically measures human’s Systolic, Diastolic blood
pressure and heart rate by using the oscillometric method during
inflation. All values can be read out in one LCD panel. Measurement
position is at human being’s upper arm. The intended use of this
over-the-counter device is for adults aged 18 years and older with arm
circumference ranging from 9 inches to 17 inches (approx.23 cm to 43
cm) and for home use.
HL858CE 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 level.
Besides, the device features a built-in "Bluetooth Data Transmission"
function, which enables the device automatically transmit measuring
results to paired Bluetooth-enabled device. 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 device.
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4
About Blood Pressure
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 evaluate
the status of a patient's blood pressure.
Many factors such as physical activity, 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 evening. It is
on average lower in the summer and higher in the winter.
2. Why is it useful to measure blood pressure
at home?
Having one's blood pressure measured by a doctor in a hospital or a
clinic, is often associated with an event called “White Coat
Hypertension” where the patient becomes nervous 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 physician 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 physicians generally recommend the “Rule of 3”, where you
are encouraged to take your blood pressure three times in a row (at
3 ~ 5 minute interval), three times a day for three days. After three
days you can average all the results and this will give you an
accurate idea of what your blood pressure really is.
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5
About Blood Pressure
A. AHA blood pressure classifications:
Standards for assessment of high or low blood pressure without regard
to age, have been established by the American Heart Association (AHA
2017), as shown in the chart.
However this chart is not exact for classification of blood pressure and
it's intended to be used as a guide in understanding non-invasive
blood pressure measurements. Please consult with your physician for
proper diagnosis.
B. Variations in blood pressure:
Individual blood pressures vary greatly both on a daily and a seasonal
basis. These variations are even 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 variations
in blood pressure over a
whole day with
measurement taken
every five minutes.
The thick line represents
sleep. The rise in blood
pressure at 4 PM (A in the
graph) and 12 PM (B in
the graph) correspond to
an attack of pain. (Direct arterial pressure recording in unrestricted man.
Beven, Honour & Stott: Clin. Sci. 36:329. 1969)
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6
Measurement Method
HL858CE Automatic Upper Arm 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 upper arm, just turn on the monitor and inflation
automatically starts. The inflation of the cuff creates pressure around
the arteries inside upper arm.
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 heart beat, and also
a result of the pressure that the cuff has placed on the upper arm. The
monitor measures these contractions and converts the information to
a digital value. 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.
*Theappliedpartisthecuff.
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7
Accuracy
HL858CE Automatic Upper Arm Blood Pressure Monitor has been
clinically tested against a scientific device called mercury
sphygmomanometer, considered the gold standard in blood pressure
measurement.
All HL858CE Automatic Upper Arm Blood Pressure Monitors have
performed equivalent to measurements taken with this scientific
device and are within the accuracy limits prescribed by the American
National Standard for Electronic or Automated Sphygmomanometers.
The SPHYGMOMANOMETER was clinically investigated according to
the requirements of ISO 81060-2:2013.
*We su
gg
est our users have their blood pressure monitor
checked every 2 years. This operation should only be performed
by Manufacturer or by authorized representatives.
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8
Precautions
* Read the Instruction Manual thoroughly before measuring and
keep it at hand for your reference at any time.
* The device is designed for home use and not suitable for clinical
use.
* This monitor is not intended for use in the MR environment.
Do not take a measurement in a low (less than 41 /℉5 )℃and high
(more than 104 /40 )℉℃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’ve just consumed
caffeinated beverages or smoked cigarettes.
Rest at least 5 ~ 10 minutes before taking a measurement.
To allow your blood vessels 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 arm (preferably the left arm)
and measuring around the same time each day.
Perform measurements in a quiet and relaxed environment at room
temperature.
Do not move or shake the device during a measurement. Please
keep quiet and do not talk during measurements.
This product is not suitable for:
Pregnant women
People with arrhythmias
Undergoing intravenous injection on any limb
Currently in a dialysis treatment
In pre-eclampsia condition
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9
*Attention
!
1.
Do not use the device on infants, children, or those who cannot express their
own
intention. To avoid accidental strangulation, keep this product away from
children and do not drape tube around neck.
2.
The medical device should not use adjacent to or stacked with other equipment.
In
case adjacent or stacked use is necessary. The medical device should be
observed to
verify normal operation in the configuration in which it will be used.
3.
Consider the electromagnetic compatibility of the device (ex. power
disturbance, radio
frequency interference etc.) Please use it indoor only.
4.
Over 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 arm. In general, these symptoms
should not last long.
However, if you do not recover in time, please seek your
medical practitioners for help.
Precautions
For those who have had mastectomy surgery (especially whose’
lymph nodes removed), it’s recommend take a measurement on
the unaffected side.
When used among medical electronic equipments on the same limb,
pressurization of the cuff may cause temporarily malfunction to
other devices.
If you have one of the circulatory problems as arteriosclerosis,
diabetes, liver disease, kidney disease, severe hypertension,
peripheral circulation……, please consult your healthcare
professional before using the device.
Blood pressure measurements determined with this device are
equivalent to those obtained by a trained observer using the
cuff/stethoscope auscultation method and are within the accuracy
limits prescribed by the American National Standard for Manual,
electronic, or Automated Sphygmomanometers.
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10
Device Overview
Part names and product components
AA “LR6” (1.5V)
ALKALINE BATTERY X 4
START / STOP
Button
ARM CUFF WITH TUBE
LCD Display
MEMORY Button BLUETOOTH
Button
DC JACK
5.99V 2A AC/DC adapter
LED Risk Category
Indicator
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D
*Caut
i
Substi
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.
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D
Bluet
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Symbol
Time:
te w
Irregu
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Risk Categ
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Date:
Unit
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S
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14
Risk Category Indicator (AHA 2017)
This device is equipped with Risk Category Indicator which classifies your
blood pressure measurements into five stages (Normal, Elevated,
Hypertension stage 1, Hypertension stage 2 and Hypertensive crisis) based
on the blood pressure standards established by the American Heart
Association (AHA). Besides, for yours and your loved ones’health, we
further classify the five stages into numeral ranges, which sorts out
hypertension symptoms more clearly. Moreover, to your convenience and
readability, we use three corresponding colors to represent your measuring
result. Refer to below comparison chart for details:
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 left 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 rate 181 & diastolic rate 99 Red category (Hypertensive crisis)
e.g. systolic rate 110 & diastolic rate 95 Red category (Hypertension stage 2)
*Note !
The above table is not exact for classification of blood pressure and it's intended to be used
as a guide in understanding non-invasive blood pressure measurements.
Usually this is not a cause for concern; however we recommend you consult with your
physician for proper diagnosis or seek medical advice according to our recommendation
mentioned above. Please note that the device does not appropriate to diagnose hypertension,
and it is only for user reference on blood pressure monitoring.
Features
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15
Advanced Average Function
The Advanced Average Function automatically takes and averages 3 readings
in a row, with 1 minute rest intervals in between each measurement. To
deactivate this feature and take only a single reading, slide the switch on the
back to the OFF position.
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
average rhythm is usually defined as an irregular heartbeat rhythm.
Talking, moving, shaking or an irregular pulse during the
measurement can result in the appearance of this symbol.
Usually this is not a cause for concern, however if the symbol appears
often, we recommend you seek medical advice.
And please note that the device does not replace a cardiac
examination, but serves to detect pulse irregularities at an early
stage.
*Note
!
The pulse display is not suitable for checking the frequency of heart pace
markers. If a certain pulse irregularity is detected during measurement often,
we recommend you seek medical advice
As a safeguard, we recommend that if you have arrhythmias such as atrial or
ventricular premature beats and atrial fibrillation or any other special
conditions you should check with your physician before using your device.
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 avoid affecting the detection of heart rate from any
movement, shaking or talking in the beginning of measurement, the method of
averaging heart beat intervals of subject device is calculated with the three
proper heart beat pulses detected in the beginning of measurement and that is
different from a strict mathematical averaging of all recorded intervals.
At least 3 beats with at least 25% difference from the average heart beat
interval will generate the IHB icon on the screen.
Features
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16
Bluetooth Data Transmission
HL858CE features a built-in “Bluetooth Data Transmission” function, which
enables the device automatically transmit measuring results to paired
Bluetooth-enabled device after measurement. When connection established,
BPM would transmit memory data such as Measure Date, Systolic, Diastolic
and Pulse to the Bluetooth enabled device.
If paired Bluetooth-enabled device is not working or is not within RF range of
this device, the measuring results will be stored in the blood pressure
monitor's memory. Besides, user can press “ ” button for one time to open
the Bluetooth function.
Bluetooth compatibility with blood pressure monitor for Bluetooth-enabled
device is:
Bluetooth 4.0 for Android 6.0 or above
Bluetooth 4.0 for iOS 7.0 or above
*Note
!
HL858CE is subject to and complies with electromagnetic compatibility
(EMC) standard of IEC 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 devices with RF capability. These
guidelines help ensure that your device will not affect the operation of
other nearby devices. Additionally, other devices should not affect the use
of your device.
Other wireless devices that are in use nearby, such as a cell or mobile
phone, or a wireless network, may prevent or delay the transmission of
data from your device to paired Bluetooth-enabled device. Moving away
from the source of the interference or turning off these devices to resolve
the problem.
Make sure HL858CE and paired Bluetooth-enabled device 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 available under measurement.
Features
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17
Features
Application Software for Bluetooth
To fully utilize this feature, users need to ensure Bluetooth support of
Wireless (usually under settings menu) on their Android or iOS device
for contactless data exchange. Then, download and install
“DailyChek®” application software from Google Play on the
Bluetooth-enabled device which is compatible with Android 6.0 or iOS
7.0 or above. Please follow the following steps for installing:
1. To install DailyChek®FREE APP, go to the Google Play TM APP store,
and search for DailyChek®.
2. Click the INSTALL button. Once installed, click on DailyChek®APP
icon.
3. Now you can start using your Android version or iOS version of
DailyChek®APP with Bluetooth feature, it’s a simple tool to log, track
and trend your test results from your Bluetooth-enabled Device.
*Note
!
1. DailyChek®Software Manual contains explanations of functions
and instructions of how to activate them.
2. Access DailyChek®Software Manual via DailyChek®Application
Software to completely utilize this feature.
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18
Features
Talking Function
The device features has Talking Function, which provides English only, for users to
hear their measurements easily.
This function is optional. Only under sleeping mode, user can switch the
function on and off.
Under sleeping mode, by pressing “+” button for 3 seconds, user
can switch on and off by following steps:
As the figure shown on the right, Audio function
is ON, the device will read your result out loud.
As the figure shown on the left, Audio function is
OFF, the device will keeps mute.
Note: The Talking Function Feature Switch default setting is ON
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19
Features
When Talking Function is on, the script is as follows:
Voice Item Voice Content
Wakeup
Please sit down and put the cuff on your left arm. Cuff
placement must match the drawing on your cuff with the
tube centered down the middle on the inside of your left
arm. Press the Start button when you are ready.
Measure Prepare Preparing to take measurement, please relax and do not
talk or move.
Measure Advanced
Average
Preparing to take 3 measurements in a row, please relax
and do not talk or move until all three measurements
are completed.
Memory empty No readings stored in memory.
Low Battery Battery weak. Please replace all batteries.
Measurement error Measurement error. Please try again.
Chime Chime noise
User 1 User 1
User 2 User 2
Data ERROR Data Transmission error, please transmit manually
Measure(Single)
Your systolic pressure is XXX
Your diastolic pressure is XXX
Your pulse is XXX
According to published standards, this reading is:
(Normal, Elevated, Hypertension stage 1, Hypertension
stage 2, and Hypertensive crisis auto selected by
measure result)
(if IHB detected)
Please note that an irregular heartbeat has been
detected.
Measure
(ADV AVE)
The average of your three readings
Your systolic pressure is XXX
Your diastolic pressure is XXX
Your pulse is XXX
According to published standards, this reading is:
(Normal, Elevated, Hypertension stage 1, Hypertension
stage 2, and Hypertensive crisis auto selected by
measure result)
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20
(if IHB detected)
Please note that an irregular heartbeat has been
detected.
RECALL
(Single)
User 1/User 2
Memory Reading number XXX
Systolic pressure XXX
Diastolic pressure XXX
Pulse XXX
According to published standards, this reading was
(Normal, Elevated, Hypertension stage 1, Hypertension
stage 2, and Hypertensive crisis auto selected by
record)
(if IHB detected)
Please note that an irregular heartbeat has been
detected.
RECALL
(last 3 average)
Memory Average
User 1 /User 2
Systolic pressure XXX
Diastolic pressure XXX
Pulse XXX
According to published standards, the average of your
last three readings was
(Normal, Elevated, Hypertension stage 1, Hypertension
stage 2, and Hypertensive crisis auto selected by
measure result)
(if IHB detected)
Please note that an irregular heartbeat has been
detected.
RECALL
(ADV AVE)
Memory Average
User 1 /User 2
Systolic pressure XXX
Diastolic pressure XXX
Pulse XXX
According to published standards, this Advanced
Average reading was
(Normal, Elevated, Hypertension stage 1, Hypertension
stage 2, and Hypertensive crisis auto selected by
measure result)
(if IHB detected)
Please note that an irregular heartbeat has been
detected.
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