HL868AX Automatic Upper Arm Blood Pressure Monitor

Product Information

Specifications

• Model No.: HL868AX

• Product Number: 323103781

• Measurement Method: Oscillometric

• Measurement Location: Upper arm

• Age Range: Adults aged 18 years and older

• Arm Circumference Range: 9 inches to 17 inches (approx.23 cm to
  43 cm)

• Intended Use: Home use

Product Usage Instructions

1. 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.

2. Intended Use

This device uses the oscillometric method to automatically
measure systolic and diastolic blood pressure as well as heart
rate. All values can be read out on one LCD panel. The measurement
position is at the human being’s upper arm. The intended use of
this over-the-counter device is for adults aged 18 years and older
with an arm circumference ranging from 9 inches to 17 inches
(approx.23 cm to 43 cm) and for home use.

The HL868AX detects the appearance of irregular heartbeats
during measurement; an indicated symbol will appear with the
measuring reading. The Risk Category Indicator will show the
information with the readings on the screen for the user tracking
their blood pressure level. The device can accurately measure blood
pressure in pregnant patients including those with known or
suspected pre-eclampsia condition.

About Blood Pressure

1. What is blood pressure?

Blood pressure is the force exerted by circulating blood against
the walls of the blood vessels. It is typically measured in
millimeters of mercury (mmHg) and consists of two values: systolic
pressure (the higher value) and diastolic pressure (the lower
value).

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?

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 intervals), 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.

Frequently Asked Questions

1. Can this device be used by children?

No, this device is intended for use by adults aged 18 years and
older.

2. Can I use this device if my arm circumference is smaller

than 9 inches or larger than 17 inches?

This device is designed to accommodate arm circumferences
ranging from 9 inches to 17 inches (approx.23 cm to 43 cm). If your
arm circumference falls outside this range, please consult with
your healthcare provider for alternative options.

3. How often should I measure my blood pressure?

It is recommended to measure your blood pressure three times in
a row, at 3 ~ 5 minute intervals, three times a day for three days.
After three days, you can average all the results to obtain an
accurate idea of your blood pressure levels.

4. Can this device detect irregular heartbeats?

Yes, the HL868AX can detect the appearance of irregular
heartbeats during measurement. An indicated symbol will appear with
the measuring reading if irregular heartbeats are detected.

Instruction Manual
Automatic Upper Arm Blood Pressure Monitor

Model No. HL868AX

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Table of Contents
Medical Disclaimer………………………………………………………….. 3 Intended Use ………………………………………………………………… 3 About Blood Pressure………………………………………………………. 4 Measurement Method ……………………………………………………… 6 Accuracy ……………………………………………………………………… 7 Precautions ………………………………………………………………….. 8 Device Overview ……………………………………………………………10 Symbol Definitions …………………………………………………………12 Features ……………………………………………………………………… 14 Installing Batteries …………………………………………………………18 Using the AC/DC Adapter …………………………………………………19 Applying the Cuff …………………………………………………………..20 Measurement Procedure…………………………………………………..21 Memory Function …………………………………………………………..25 Storage and Maintenance …………………………………………………28 Troubleshooting …………………………………………………………….30 Limited Warranty……………………………………………………………32 Specifications ……………………………………………………………….33 Note …………………………………………………………………………..34 Appendix …………………………………………………………………….. 36 Blood Pressure Diary ………………………………………………………39

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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
This device uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. All values can be read out on 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.
HL868AX 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.
The device can accurately measure blood pressure in pregnant patients including those with known or suspected in pre-eclampsia condition.
Besides, the device features a built-in “Bluetooth Data Transmission” function, which enables the device automatically transmits 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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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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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 hypertensive

patients. Normally the blood pressure rises while at work and is at its

lowest during sleeping period.

(hypertension: means a person who has high blood pressure

symptom.)

The graph below

illustrates 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 AM (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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Measurement Method
HL868AX 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 heartbeat, 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 completed, the cuff will automatically deflate.

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Accuracy
HL868AX 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 HL868AX 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.
In case it is needed to have the device checked for calibration, please consult the distributor. This is recommended to be considered every two years.

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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.
• The patient is an intended operator, who can operate the device by himself or herself, not necessarily by a physician or operator.
• This monitor is not intended for use in the MR environment.
  Do not take a measurement in a too low (less than 41/5) or too
  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. Please rest for 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 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. If you are pregnant, you should pay more attention to your blood pressure changes, because during this time, it may change drastically. This monitor is clinically validated for use in pregnancy and pre-eclampsia. When you detect unusual readings in pregnancy, you should measure again after taking some rest. If the reading is still abnormal, consult your doctor or gynecologist. This product is not suitable for: People with arrhythmias Undergoing intravenous injection on any limb Currently in a dialysis treatment In pre-eclampsia condition The applied part is the cuff.

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Precautions
For those who have had a mastectomy or lymph node clearance, it
is recommended to 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 such 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. Results are not intended for direct diagnosis. Please consult with a physician if you have any questions or concerns about your results.
*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 be used 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.

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Device Overview

Part names and product components

Arm Cuff Hole

5V 1.2A AC/DC Adapter (Optional)

DC Jack

5V 1.2A AC/DC Adapter (Optional)

LCD Display

Risk Category Indicator

User-Select/ Mode Button

START / STOP Button

Advanced Average Function Switch
Memory Set /Bluetooth Button

Arm Cuff With Tube

AAA “LR03” (1.5V) Alkaline Battery X 4

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Device Overview

Unit display
Month/Date/Year
Hour:Minute with PM icon Bluetooth Symbol
Advanced Average Measurement Result
AM/PM Averaging User Symbol
Risk Category Indicator

Systolic Pressure
Low Battery Symbol
Advanced Average Symbol Average of Last 3 Measurement
1. Excessive Body Motion Detector
2. Cuff Fitness Detector
Diastolic Pressure

Heart Rate

Irregular Heartbeat Detector Pulse Symbol

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Symbol Definitions

SYMBOLS

Definitions

Low Battery Symbol

This symbol appears when the battery power is extremely low or the polarity reverses.
We suggest you replace all batteries with new ones, and make sure the +/- polarities are properly positioned.

Pulse Symbol
Irregular Heartbeat Detector

Once pulse is detected, the symbol flashes with each pulse beat.
This symbol appears when the user was talking, moving, shaking, or an irregular heartbeat was detected during measurements.
Our suggestion: Please do not talk or move during measurements. Repeat the measurement after resting for at least 5 minutes, and restart your measurement while sitting down comfortably and quietly.

The arrowhead points out the specific Risk Category that your Risk Category Indicator measurement reading fits in.

Advanced Average Symbol

This symbol appears when viewing an advanced average

Advanced Average Measurement Result

Indicates which measurement is being taken, or which measurement is being viewed from an advanced average reading.

Average of Last 3 Measurements
AM/PM Averaging

This symbol appears when LCD displays average value of last 3 readings.
This symbol appears when LCD displays an average from the last 3 morning or last 3 evening measurements.

User 1
User 2
Excessive Body Motion Detector

Appears when the monitor is operated by User 1.
Appears when the monitor is operated by User 2.
This symbol appears if body movement is detected during measurement, especially the movement on the arm that the blood pressure monitor is worn on. Notice: The measured blood pressure reading may not be accurate if the icon is displayed.

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Symbol Definitions

Cuff Fitness Detector

This symbol appears 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.

Bluetooth Symbol

Under Bluetooth Data Transmission / Link Mode, LCD displays this symbol.

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Features
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 pressure 181 and diastolic pressure 99 Red category (Hypertensive crisis) e.g. systolic pressure 110 and diastolic pressure 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.

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Features
Advanced Average Function
The advanced average function automatically takes and averages 3 readings in a row, with 1 minute rest intervals between each measurement. To deactivate this feature and take only one 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
pacemakers. 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 designed neither 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 heartbeat intervals of subject device is calculated with the three proper heartbeat 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 25% or greater difference from the average heartbeat interval will generate the IHB icon on the screen.

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Bluetooth Transmission
HL868AX features a built-in “Bluetooth Data Transmission” function, which enables the device automatically transmits measuring results to paired Bluetooth-enabled device after measurement. When connection is established, BPM would transmit memory data such as Measure Date, Systolic, Diastolic and Pulse to the Bluetooth enabled device.
Before attempting to sync the device with your smart device, make sure Bluetooth function is turned ON in both your smart device and the monitor, and make sure your Bluetooth-enabled device has downloaded the App. See the “App for Bluetooth” section for details.
Transmit Readings
Bluetooth function can be activated only when Bluetooth is turned ON. To turn on Bluetooth, please refer to Setting Year, Date and Time section.
1. There are 2 ways to activate Bluetooth Function.
a. Automatically Activate: When a measurement is completed, the device activates Bluetooth Function automatically, and Bluetooth symbol will be flashed on the screen.

Single Measurement Bluetooth Symbol Flashing

ADV Measurement Bluetooth Symbol Flashing

b. Manually Activate (when the Bluetooth function is ON):

Under sleeping mode, user can press the

button for 3

seconds to activate Bluetooth function, and Bluetooth symbol

will be flashed on the screen.

2. If HL868AX is connected successfully to your smart device,

Bluetooth symbol

will appear on the screen.

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Bluetooth Transmission
Date/Time Synchronization
1. The date/ time setting of HL868AX can be synchronized by Bluetooth-enabled device (e.g. smartphone) which has downloaded and installed DailyChek® application software.
2. When Bluetooth connection is established, the Bluetooth-enabled device can send commend with the date/ time information to BPM and the BPM’s date/ time will be updated.
App for Bluetooth
Download and install “DailyChek®” app on your smart device from Google Play or App store.
System requirement of the Bluetooth-enabled device
Bluetooth 4.2 for Android 6.0 or above
Bluetooth 4.2 for iOS 7.0 or above
Note HL868AX 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 HL868AX 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 data transmission is not available under measurement.
Note Without any operation in 1 minute, the device shuts off
automatically and Bluetooth Transmission will be turned OFF.

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Installing Batteries
When low battery symbol appears on the display or nothing appears on the display when the power is switched on, please change the batteries. Replace all the batteries with new ones and do not mix new and old batteries. All batteries used must be the same type. Do not mix alkaline, standard (carbon- zinc) or rechargeable (cadmium) batteries either. It may shorten the battery life or cause the device to malfunction.
Slide the battery cover and insert 4 AAA (1.5V, LR03) alkaline batteries into the battery compartment as shown on the figure below. Make sure the polarities “+” and “­” ends are coinciding with similar markings engraved 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 prevent damage caused by leakage, remove the
batteries from the device if the device is not to be used for a long period. Memories (if any) will not be deleted during battery replacement. Please replace all worn-out batteries with new ones when you are operating the

Bluetooth transmission function and the low battery symbol

appears on the

display. After replacing the batteries, the date and time will be reset.

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Using the AC/DC Adapter
This monitor is designed for operation with batteries or an AC/DC adapter. Please use only a compatible AC/DC adapter with required voltage and current as indicated in this manual.
Note No batteries are needed when operating with an AC/DC adapter. Please unload the batteries when operating with an AC/DC adapter
for an extended period of time. Leaving the batteries in the compartment for a long time may cause
leakage, which may lead to damage of the unit. Recommend Adapter specification, do not use otherwise: Model: FranMar International, FRM06-S05-UU Rating:
Input: 100-240V, 50/60 Hz, 0.2A Output: 5V, DC, 1.2A
Note When you use the blood pressure monitor with AC/DC adapter, do not position the device to make it difficult to disconnect the adapter plug.

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Applying the Cuff
Wrap the cuff on a bare arm or over thin clothing. Thick clothing or a rolled up
sleeve will cause inaccurate blood pressure measurements. Press your brachial artery approximately 1 inch (2 ~ 3 cm) above the elbow on
the inside of your left arm to determine where your strongest pulse is. Slide the end of arm cuff furthest from the tube through
the metal ring to a loop. The smooth cloth should be on the
inside of the cuff. If the cuff is located correctly, the velcro will be on the
outside of the cuff, metal ring will not touch your skin, and
the arrow on the cuff should be fallen within the Proper Fit
Range (Figure 1). Put left arm through the cuff loop. The tube should lie over the brachial artery on
the inner part of the arm. The bottom edge of the cuff should be approximately. 1 inch (2 ~ 3
cm) above the inner elbow.
Pull the end of the cuff so that it tightens evenly around your arm,
allowing room for 2 fingers to fit between the cuff and your arm
(Figure 2). When the cuff is positioned properly, press the velcro firmly against
the pile side of the cuff and make sure the cuff is not slipped during
measurement, and the arrow falls within the Proper Fit Range.
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, so that the cuff is at the same level as your
heart(Figure 3). Relax your arm and turn your arm upward. Make sure there are no kinks in the air tube.
Note Fit the cuff snugly, leaving enough space for 1 inch (2 ~ 3 cm) between the inner elbow and
the lower edge of the cuff, or the measurement may not be accurate. In case the cuff kept pumping up non-stop, unwrap the cuff at once. Do not wrap the cuff around any body part other than your arm. Do not use this device if your arm has any wound or injury, especially after surgery on the
arm. Otherwise, it may cause infection at the surgical site. Please use the device after the wound has healed. If there is one of situations mentioned below, please dispose the device without reuse. If you have any infectious skin disease or the device is used by users with infectious skin disease, please do not continue using the device. Before using the device, user should check the appearance of cuff. If you notice blood or other soil on cuff, please do not use this device.

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Measurement Procedure

Switch on the Monitor
A. Put in 4 AAA 1.5V (LR03) alkaline batteries.
B. All segments appear on the screen for 1.5 seconds.
C. The monitor will automatically turn to sleeping mode (all LCD segments are cleared).

Setting Year, Time and Date

1. Set Manually. A. Under sleeping mode, to enter setting mode

press

button for 3 seconds, then

Month digit flashes.

B. Press month.

button to select current

When above settings are done,

Press

button to adjust current DATE. Press

button to select current date.

C. Continue to set current YEAR, HOUR (1, 2……12PM, 1PM……,12)

and MINUTE (00,01……,59) by following Step B.

D.Users can adjust MONTH-DATE-YEAR-HOUR-MINUTE in an orderly

manner.

Press button to switch to the Bluetooth

setting.

2. Using your Bluetooth smart device.

The date and time on your monitor can be automatically updated, when you connect it with your smart device.

Once the date and time have been successfully synced, future

readings will automatically have the correct date and time.

Turning Bluetooth Function ON/OFF

Press button to enter the Bluetooth setting. The

default setting of this function is turn Bluetooth function ON or OFF.

ON. Press button to

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Measurement Procedure
Bluetooth function ON Bluetooth function OFF
Taking a Measurement
A. Check and select functions of advanced average mode if needed.

1. If functions of advanced average mode is on, the symbol will be shown on the display, press START/STOP button to start an advanced average measurement.
2. If functions of advanced average mode is off, press START/STOP button to start single measurement.

B. Press

button to select the user (see LCD Displays below).

C. Start a Single Measurement: 1. Make sure the advanced average function switch is turned off.
2. As the cuff inflates, the monitor automatically determines your ideal inflation level. This monitor detects your blood pressure and pulse rate during inflation. The Pulse Symbol ( ) flashes at every heartbeat. Remain still and do not move until the entire measurement process is completed.
*Note If the cuff does not stop inflating, remove the cuff at once. To stop measurement, press START/STOP button. The cuff will deflate
immediately after the button is pressed.

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Measurement Procedure
3. After the monitor has determine your blood pressure and heart
rate, the cuff automatically deflates. Your systolic pressure,
diastolic pressure, pulse rate and corresponding Risk Category
Indicator, Irregular Heartbeat Detector and Excessive Body
Motion Detector (if any) are displayed with date and time for 1
minute and save results to memory automatically.
4. After measurement is completed, the device activates
Bluetooth function automatically and the Bluetooth symbol will
flash on the screen. If the monitor cannot be connected to paired Bluetooth- enabled device over 45 seconds, LCD will display Error message “E4” and Bluetooth will be turned off.
D. Start an Advanced Average Measurement: The monitor will take 3 continuative measurements.
1. Make sure the advanced average function switch turned on. With the cuff wrapped around your upper arm, press START/STOP button to start the measurement. All display units appear on the screen, and will automatically start the 1st measurement (“1” flashes while measuring).
2. After the 1st measurement is finished, measuring result will not be shown, and display turns to 1 minute countdown directly for the 2nd measurement.
3. When times out, the monitor starts the 2nd measurement (“2” flashes, “1” stays non-flashing while measuring).
4. After the 2nd measurement is finished, measuring result will not be shown, and display turns to 1 minute countdown directly for the 3rd measurement.
5. When times out, the monitor starts the 3rd measurement (“3” flashes, “1” and “2” stays non-flashing while measuring)
6. As the cuff inflates, the monitor automatically determines your ideal inflation level. This monitor detects your blood pressure and pulse rate during inflation. The Pulse Symbol ( ) flashes at every heartbeat. Remain still and do not move until the entire measurement process is completed.

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Measurement Procedure

All Segment

1st Inflation

1 min countdown

2nd Inflation

Average result of 3 times measurement

3rd Inflation

1 min countdown

7. After the monitor has determine your blood pressure and

pulse rate, the cuff automatically deflates. Your systolic

pressure, diastolic pressure, pulse rate and corresponding

risk category indicator and irregular heartbeat detector, and

excessive body motion detector (if any) are displayed with

date and time for 1 minute and save results to memory

automatically.

8. After measurement is completed, the device activates

Bluetooth function automatically and the Bluetooth symbol

will flash on the screen.

If the monitor cannot be connected to paired

Bluetooth-enabled device over 45 seconds, LCD will display

error message “E4” and Bluetooth will be turned off.

9. Press

button to review individual

measurement result.

*Note

1. Do not inflate the cuff until it is wrapped around your upper arm.

2. To stop measurement, you may press START/STOP button.

Press button to enter memory mode.

Press button 3 seconds to Date/ Time setting mode.

5. Press START/STOP button to stop measurement and turn to sleeping mode. 6. The monitor will automatically switch to sleeping mode if no operation in 1

minute.

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Memory Function
Storing Data
After each measurement, the systolic and diastolic pressure, heart rate, risk category indicator, irregular heartbeat detector, and excessive body motion detector (if any) with date and time will be automatically stored.
The monitor features 2 user memory capabilities. Each user holds the last 120 measurements, and automatically replacing the oldest data with new one.

Memory Function

A. Press

button to enter memory mode.

B. Press

button to see previous measuring results,

including average of last 3 measurements, an advanced

average measurement, AM/PM average and individual

measurement.

An average of advanced average measurement (Press button to review individual
readings)

An average of Last 3 Measurements
An average from the last 3 morning or last 3 evening measurements.
Note: The advanced average and its 3 individual measurements are counted as 4 readings when stored in memory.

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Memory Function

Recalling Data

A. Select user first.

B. Press button to enter memory mode. If there is no data stored before, nothing (except month, date, and time) will be appeared on the display. If yes, the first reading will be the average of last 3 measurements.

(The advanced average result and its individual measurements will not be included as the average of last 3 measurements. See the example below.)

Average of Last 3 Measurements

C. Press

button again,

LCD displays average of latest 3 AM

measurements, and then is average of latest 3 PM

measurements. If fewer than 3 measurements in

AM or PM, the average will not be displayed.

SYMBOL

Status
An average of Last 3 Morning Measurements (4:00 AM ­ 12:00 PM)
An average of Last 3 Nighttime Measurements (6:00 PM ­ 2:00 AM)

D. Press

button again, LCD displays the

single measurement result or the average of advanced average

measurement (if any). Press button to read 3 results of advanced

average measurement.

E. Every new press of the

button will recall a previous reading.

The latest reading will be recalled first. Press

button

repeatedly to review the previous readings stored in the memory.

F. To stop reading memories, press START/STOP button to switch to sleeping mode.

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Memory Function

<e.g. 59th result is an advanced average result :>

Press

button to read 3 individual results (58th, 57th and 56th)

of advanced average (59th)

59th advanced average result (Average of 58th, 57th, and 56th)

58th result

57th result

56th result

Average of the last 3 measurements is the average of 60th, 55th and 54th results. (59th, 58th, 57th and 56th results are excluded).

Erasing Data

A. Select User first.

B. Press

button to enter memory

mode.

C. Press and hold

and

buttons at the same time, the data will be

erased automatically. LCD Displays “CLR” for 3

seconds.

D. To confirm deletion, press

button and

no data should appear.

Note: Once deleted, your data can NOT be restored.

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Storage and Maintenance

General Use

Do not twist the cuff in any way.

Do not press

button if the cuff is not wrapped around

your upper

arm.

Do not drop the product and avoid any strong impacts.

Maintenance

Do not attempt to disassemble or change any parts of the monitor, only trained technicians are allowed to repair and disassemble the device, including the software upgrades, cuff, patches and maintenance because a substitution of a component different from supplied might result in measurement error.
If any suggestion or service is requested, please consult your service station.
Do not implement the maintenance procedures for equipment during measurement.
To ensure that your device is in optimal use and to avoid damage, please refer to the following instructions: Clean the device and cuff with a soft dry cloth, or Use a dry cloth with water to clean the device (do not flush it directly,
do not soak it in water, and hold the device dry), or Do not use detergent or any strong chemicals to clean the device. Make sure the cuff is completely dry before using. According to the use environment of the sphygmomanometer, the recommended disinfection method and frequency are as follows: Only use it yourself (home use), it can be cleaned at ordinary times,
and wipe it once a month with a commercially available 75% alcohol cotton sheet (for the cuff) for more than 30 seconds each time. If it is used for more than one person (home use), it can be cleaned at ordinary times. It is disinfected once a week (for the cuff belt) with a commercially available 75% alcohol cotton sheet, for more than 30 seconds each time. After cleaning / disinfecting/ before using, please make sure that there are no blood stains or soil on the LCD, the device and cuff, If there is any blood stains or soil, please dispose the device without reuse.

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Storage and Maintenance
If it is used in a complex environment (such as a hospital) or after multiple people (non-family), please discard the old cuff and replace it with a new one.
Storage
If the device is not to be used for a long time, please remove the batteries from the device (leaking of battery acid can cause the device to malfunction).
Always store the unit in the storage case after use. It is intended to be transported or stored in a carrying case between uses.
Do not place the device directly under sunlight, in high temperature, or in humid or dusty places.
Do not store the device in extremely low (less than ­13/­25) and high (more than 158/70) temperature, nor in a place its humidity exceeds 93% R.H.

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Troubleshooting

SYMBOLS/SYMPTOMS

CONDITIONS/CAUSES

Unit does not turn on when START/STOP button is pushed.

Worn-out batteries.
Battery polarities have been positioned incorrectly.

INDICATION/ CORRECTION Replace them with 4 new AAA (LR03) alkaline batteries.
Re-insert the batteries in the correct positions.

Cuff has been placed incorrectly.

Measuring Error Symbol

appears when blood pressure value displayed is excessively low or high.

Did you talk or measurement? Shaking of the

move during arm with the

cuff

on

Wrap the cuff properly so that it is positioned correctly.
Measure again. Keep arm steady during measurement.

Air circuit abnormality. Cuff tube may Check cuff connection. Measuring Error Symbol not be plugged into monitor correctly. Measure again.

Inflation pressure exceeding 300 Measuring Error Symbol mmHg.

Switch the unit off, then measure again.

Can’t determine blood pressure measurement data. Measuring Error Symbol Cuff is worn improperly, or the shape of the upper arm is unusual (for example, the circumference of the upper arm differs largely from the circumference of the forearm), excessive gap might be exist between the arm cuff and the arm.
If HL868AX cannot be connected to paired Bluetooth-enabled device over Measuring Error Symbol 45 seconds, LCD will display Error message “E4” and Bluetooth will be turned off.

Wrap the cuff properly and keep steady. Measure again. Wrap the cuff properly and keep steady. Measure again.

If you have any question

about the cuff wearing and/or

measurement result, please

consult your healthcare

professional.

Please press

button

for 3 seconds to start Bluetooth

function.

Excessive Body Motion Detector

Body movement during measurement, especially, the movement on the arm the blood pressure monitor is worn on. e.g. Talking, moving or shaking of the arm with the cuff on while measurement.

Cuff is worn improperly, or the shape

Notice: The measured blood pressure reading may not be accurate if the icon is displayed.

of the upper arm is unusual (for example, the circumference of the upper arm differs largely from the circumference of the forearm), excessive gap might be exist between

the arm cuff and the arm.

Measure again. Keep arm steady during measurement.
Wrap the cuff properly and keep steady. Measure again.
If you have any question about the cuff wearing and/or measurement result, please consult your healthcare professional.

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Troubleshooting

Cuff Fitness Detection Symbol

The cuff was wrapped incorrectly (for example too loosely or too tightly).
Paring has not been completed.

Bluetooth function is not turn on.

The distance between BPM and

BPM cannot communicate Bluetooth-enabled device is out of

with Bluetooth-enabled transmitting range.

device

Use an incompatible

Bluetooth-enabled device.

Use non-Bluetooth-enabled device.

Please reference “Applying the Cuff “section to wrap the cuff correctly.

Please re-pairing the BPM

and Bluetooth -enabled

device with each other.

Please

press

button for one time under

sleep mode.

Please make sure the

acceptable distance (10

meters) with each other.

Please refer to

“Bluetooth compatibility” and “RF Specification”

Unexpected loss of electrical/mechanical integrity.

Re-insert the batteries and try again.
Return the device to your local distributor or importer.

Note: If “EP” appears on the display, just return the device to your local distributor or importer.

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Limited Warranty
Warranty For Two Years from the manufacturing date
Please note that this warranty does not cover damage caused by misuse or abuse; accident; the attachment of any unauthorized accessory; alteration to the product; improper installation; unauthorized repairs or modifications; improper use of electrical/power supply; loss of power; dropped product; malfunction or damage of an operating part from failure to provide manufacturer’s recommended maintenance; transportation damage; theft; neglect; vandalism; or environmental conditions; loss of use during the period the product is at a repair facility or otherwise awaiting parts or repair; or any other conditions whatsoever that are beyond the control of importers or distributors.

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Specifications

Model Number
Measurement Method
Rated Range of Cuff Pressure
Rated Range of Determination
Measurement Range of Heart Rate
Accuracy
Inflation Deflation Display Memory RF Type Unit Dimensions Unit Weight (Cuff & Batteries Excluded) Cuff Size Storage/ Transportation Environment Operation Environment
Power Supply
Battery Life
Shelf Life (battery)
Product Life
Sleeping Mode
Accessories

HL868AX
Oscillometric
0~300 mmHg
40~280 mmHg
40~199 Beats/Minute
Pressure: ±3 mmHg Pulse: ±5% Max. Automatic Inflation (Air Pump) Automatic Air Release Control Valve Liquid Crystal Display 240 Memory Total for 2 Users Bluetooth 5.0 BLE 4.5 X 5.6 X 1.9 inch (L X W X H) 114 X 143 X 46 mm (L X W X H)
269.8 g ± 5 g (9.51 oz ± 0.17 oz)
UC01:Universal size cuff (9″ ~17″/23 ~ 43 cm) Temperature: -25°C ~70°C (-13°F ~158 °F) Humidity: 93% R.H. Temperature: 5°C ~ 40°C (41°F ~104°F) Humidity: 15% ~ 93% R.H. Atmospheric pressure: 700hPa ~ 1060hPa 1. DC 6V, AAA “LR03” (1.5V) Alkaline Battery x 4 2. DC 5V 1.2A AC/DC adapter (Optional) Approx. 200 Measurements 3 years (Temperature: 20 ± 2°C; Relative humidity: 65 ± 20%RH) 5 Years (4 times per day) Without any operation for 1 minute, device automatically shuts off 4 AAA (LR03) Alkaline Batteries, Arm Cuff with Tube, Instruction Manual, Pouch

*The contents of this manual and the specifications of the device covered by this manual are subject to change for improvement without notice.

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Note
Explanation of symbols:

Symbol

Explanation Refer to instruction manual/booklet

Health & Life Information –

TYPE BF Applied Part

–

To avoid inaccurate results caused by electromagnetic interference

Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the device, Otherwise, degradation of the performance of this equipment could result.

Waste of electrical and electronic equipment (WEEE)

Discard the used product to the recycling collection point according to local regulations

Serial number
Ingress Protection Rating
Non-ionizing electromagnetic radiation

YYMMXXXXXX
First characteristic numeral- Degree of protection against access to hazardous parts and against solid foreign objects N1=2 (Protected against solid foreign objects of 12.5 mm Ø and greater)
Second characteristic numeral- Degree of protection against ingress of water N2=2 (Protected against vertically falling water drops when ENCLOSURE tilted up to 15°)
–

Device information: – Internally powered equipment – Not suitable for use in presence of flammable anesthetic mixture with air or with Oxygen or nitrous oxide – Continuous operation with short-time loading
Manufacturer: HEALTH & LIFE CO., LTD. 9F, No. 186, Jian Yi Road, Zhonghe District 23553, New Taipei City, Taiwan www.healthandlife.com.tw

Distributor: HoMedics USA, LLC 3000 N. Pontiac Trail, Commerce Township, MI 48390 Phone: 1-800-466-3342

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Note
Note This equipment has been tested and found 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 installed and 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 off and on, the user is encouraged to try to correct the interference by one or more of the following measures: The user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and the receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help.
FCC RF Radiation Exposure Statement: 1. The equipment complies with FCC RF exposure limits set forth for an uncontrolled environment. 2. The equipment must not be co-located or operation in conjunction with any other antenna or transmitter.
FCC Label Compliance Statement: 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.
Note To assure continued FCC compliance: Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment.
HL868AX essential performance per IEC 80601-2-30 additional essential performance requirements: 201.12.1.102 Limits of the error of the manometer from
environmental conditions
Over the temperature range of 5 °C to 40 °C (41 °F ~ 104 °F ) and
the relative humidity range of 15 % to 93 %(non-condensing), the
maximum error for the measurement of the CUFF pressure at any
point of the NOMINAL measurement range shall be less than or equal
to ± 3 mmHg (± 0.4 kPa) or 2 % of the reading, whichever is greater. 201.12.1.107 Limits of the change in error of the blood pressure
determination
The laboratory limits of the change in error of the BLOOD PRESSURE
DETERMINATION of the AUTOMATED SPHYGMOMANOMETER shall be
less than 3 mmHg (0.4 kPa).

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Appendix

Guidance and manufacturer’s declaration ­ electromagnetic emissions

The device is intended for use in the electromagnetic environments listed below, and should only be used in such environments:

Emissions test
RF emissions CISPR 11

Compliance Group 1

Electromagnetic environment ­ guidance
RF energy is used only to maintain device’s operation. Therefore, its RF emissions are so low that it’s not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions

Class B Class A Complies

The device is suitable for use in all establishments, including domestic establishments, and those directly connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.

IEC 61000-3-3

Guidance and manufacturer’s declaration ­ electromagnetic immunity

The device is intended for use in the electromagnetic environments listed below, and

should only be used in such environments:

Immunity test
Electrostatic discharge (ESD) IEC 61000-4-2

IEC 60601 test level
± 8 kV contact discharge

Compliance level
± 8 kV contact discharge

± 15 kV air discharge ± 15 kV air discharge

Electromagnetic environment ­
guidance
In the case of air discharge testing, the climatic conditions shall be within the following ranges:
Ambient Temperature:15~35 , Relative Humidity:30%~60%.

Power frequency (50 or 60 Hz) magnetic field IEC 61000-4-8

30 A/m 50 or 60 Hz

30 A/m 50 or 60 Hz

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5
interruptions and voltage variations on power supply input lines
IEC 61000-4-11

± 2 kV for power supply lines
± 1 kV for input/output lines
AC Power port ±1 KV Line to Line

± 2 kV for power supply lines
± 1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

AC Power port ±1 KV Line to Line

Mains power quality should be that of a typical commercial or hospital environment.

0% UT; 0.5 cycle At 0°,45°,90°,135°,180 °,225°,270°and 315°.

0% UT; 0.5 cycle At 0°,45°,90°,135°,180 °,225°,270°and 315°.

0 % UT; 1 cycles

0 % UT; 1 cycles

70 % UT; 25/30 cycles 70 % UT; 25 cycles

Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.

0 % UT; 250/300 cycle 0 % UT; 250 cycle

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Appendix

Guidance and manufacturer’s declaration ­ electromagnetic immunity

The device is intended for use in the electromagnetic environments listed below, and should only be u

used in such environments:

Immunity test
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3 Proximity fields from RF wireless communications equipment IEC 61000-4-3

IEC 60601 test level
3V rms At 0.15-80 MHz
6V rms At ISM & Radio Amateur Freq.
10 V/m at 80-2700 MHz AM Modulation And 9-28V/m at 385-6000MHz,Pulse Mode and other Modulation. The system shall be tested as specified in IEC60601-1-2 Table 9 for proximity fields from RF wireless communications equipment using the test methods specified in IEC 61000-4-3

Compliance level
3V rms At 0.15-80 MHz
6V rms At ISM & Radio Amateur Freq.
10 V/m at 80-2700 MHz AM Modulation And 9-28V/m at 385-6000MHz,Pulse Mode and other Modulation. The system shall be tested as specified in IEC60601-1-2 Table 9 for proximity fields from RF wireless communications equipment using the test methods specified in IEC 61000-4-3

Electromagnetic environment ­
guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance Considering to reduce the minimum separation distance, based on RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the following equation:
E = 6/d where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST LEVELS in V/m.

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1) Note 2)

At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.

b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m

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Appendix

Test specifications for enclosure port immunity to RF wireless communications equipment.

Test frequency (MHz)

Modulation

IMMUNITY TEST LEVEL
(V/m)

385

Pulse modulation 18 Hz

27

450

FM ± 5 kHz deviation 1kHz sine

28

710

745

Pulse modulation 217 Hz a)

9

780

810

870

Pulse modulation 18 Hz a)

28

930

1720

1845

Pulse modulation 217 Hz a)

28

1970

2450

Pulse modulation 217 Hz a)

28

5240

5500

Pulse modulation 217 Hz a)

9

5785
NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m, The 1 m test distance is permitted by IEC 61000-4-3.

a) The carrier shall be modulated using a 50% duty cycle square wave signal. b) AS an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used
because while it does not represent actual modulation, it would be worst case.

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Blood Pressure Diary

Date Systolic / Diastolic Date Systolic / Diastolic Date Systolic / Diastolic Date Systolic / Diastolic Date Systolic / Diastolic Date Systolic / Diastolic Date Systolic / Diastolic Date Systolic / Diastolic Date Systolic / Diastolic Date Systolic / Diastolic

Time Time Time Time Time Time Time Time Time Time

Before After
Pulse

Meal

Before After
Pulse

Meal

Before After
Pulse

Meal

Before After
Pulse

Meal

Before After
Pulse

Meal

Before After
Pulse

Meal

Before After
Pulse

Meal

Before After
Pulse

Meal

Before After
Pulse

Meal

Before After
Pulse

Meal

P/N323103781

VERA001

20230419

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References

• 合世生醫科技股份有限公司

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