FCC ID: 2ABTAHNL85DM1 Automatic Wrist Blood Pressure Monitor

IInnssttrruuccttiioonn MMaannuuaall Automatic Upper Arm Blood Pressure Monitor Model No. HL858DM 1 VER: A001 202203 Table of Contents Medical Disclaimer03 Intended Use..03 About Blood Pressure04 Measurement Method06 Accuracy.07 Pr e caut io n s .0 8 Device Overview.11 Symbol Definitions.13 Features15 Installing Batteries.20 Using the AC/DC Adapter21 Applying the Cuff.22 Measurement Procedure..23 Memory Function.26 Bluetooth Transmission.27 Storage and Maintenance.29 Troubleshooting.31 Limited Warranty.32 Specifications.33 Note..35 Appendix..36 Blood Pressure Diary...39 2 VER: A001 202203 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. The measurement position is at human beings arm. All values can be read out in the LCD panel. Measurement position is intended user of this at human beings upper arm. The over-the-counter device is adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) for home use. HL858DM features BP Category Indicator that will show the information with the readings on the screen for the user tracking their blood pressure level. HL858DM is equipped with an Advanced IHB (Irregular heartbeat) detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with deviation, the device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected. Besides, the device features a built-in "Bluetooth 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. 3 VER: A001 202203 About Blood Pressure A. 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. B. 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 a phenomenon 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 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 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. 4 VER: A001 202203 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 below chart. BLOOD PRESSURE CATEGORY NORMAL ELEVATED HIGH BLOOD PRESSURE

(HYPERTENSION)STAGE 1 HIGH BLOOD PRESSURE

(HYPERTENSION)STAGE 2 HYPERTENSIVE CRISIS SYSTOLIC mm Hg

(upper number) LESS THAN 120 120-129 130-139 DIASTOLIC mmHg

(lower number) LESS THAN 80 LESS THAN 80 80-89 and and or 140 OR HIGHER or 90 OR HIGHER

(consult your doctor immediately) HIGNER THAN 180 or HIGHER THAN 120 However the above 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 line thick represents sleep. The rise in blood pressure at 4 PM (A in the graph) and 12 AM (B in graph) correspond to an attack of pain. the

(Direct arterial pressure recording in unrestricted man. Beven, Honour & Stott: Clin. Sci. 36:329. 1969) 5 VER: A001 202203 Measurement Method HL858DM 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.

* The applied part is the cuff. 6 VER: A001 202203 Accuracy HL858DM 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 HL858DM 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 Sphygmomano-

meters. The SPHYGMOMANOMETER was clinically investigated according to the requirements of ISO 81060-2:2018. 7 VER: A001 202203 Precautions

* Do not use this manual and product as a substitute for advice, diagnosing or treating a health problem or prescribing any medication by your doctor. If you have a medical problem, promptly consult your healthcare provider.

* Read the Instruction Manual thoroughly before measuring and keep it at hand for your reference at any time.

* This device uses the oscillometric method to measure systolic and diastolic blood pressure as well as your heart rate. Its recommended for use by people over the age of 18 and not to be used on infant or children.

* 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 low (less than 41 /5 ) and high

(more than 104 /40 ) temperature, nor in a place outside humidity Wait 30 ~ 45 minutes before measurement if youve just consumed ranges (15 % ~ 93 % R.H.), and altitude ranges (700 ~ 1060 hPa), or caffeinated beverages or smoked cigarettes. you may get inaccurate readings. 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. Sit down comfortably and place your elbow on the table with your feet flat on the floor. Please do not cross your legs during measurements. Keep the cuff at heart level. Relax your hand with the palm facing up. 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 8 VER: A001 202203 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 equipment on the same limb, pressurization of the cuff may cause temporarily malfunction to other devices. Keep in mind that blood pressure naturally varies from time to time throughout the day and is affected by lots of different factors such as stress, eating, smoking, alcohol consumption, medication, and Normally the blood pressure rises while at work and is at its lowest physical activity, etc. during sleeping period. Blood pressure measurements should be interpreted by a physician or a trained health professional who is familiar with your medical history. Using the unit and recording the results regularly for your physician to interpret, you will keep your physician informed of the continuing changes in your blood pressure. 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. Results are not intended for direct diagnosis. Please consult with a physician if you have any questions or concerns about your results. Blood pressure measurements taken 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 Standard of EN 1060-4. If the cuff is worn incorrectly, or the shape of the upper arm is special (for example, the circumference of the upper arm differs largely from the circumference of the forearm), excessive gap might occur between the arm cuff and the arm, and it might lead to measurement errors or inaccuracies. If you have any question about the condition of cuff wearing and/or measurement result, please consult your healthcare professional. The applied part is cuff. 9 VER: A001 202203 Precautions

*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 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. 10 VER: A001 202203 Device Overview Part names and product components LCD DISPLAY Arm Cuff hole DC JACK 5V A AC/DC Adapter Risk Category Indicator LCD DISPLAY

(Advanced IHB) START / STOP BUTTON

(Advanced IHB) DETECTION AREA ARM CUFF WITH TUBE

*Caution AA LR6 (1.5V) ALKALINE BATTERY X 4 Substitution of a component different from that supplied might result in measurement error. 11 VER: A001 202203 TIME BUTTON MEMORY BUTTON Bluetooth BUTTON USER/SET BUTTON Device Overview Unit display Hour : Minute

(Also represents YEAR in Setting Mode) Systolic Pressure Risk Category Indicator 1.Excessibe Body Motion Detector 2.Cuff Fitness Detection Diastolic Pressure Heart Rate Bluetooth Symbol Blood Pressure Unit Low Battery Symbol Pulse Symbol Month / Date Memory Average 12 VER: A001 202203 Symbol Definitions SYMBOLS Definitions This symbol appears when the battery power is excessively low or the polarity reverses. We suggest you replace all batteries with new ones, and make sure the +/- polarities are properly positioned. Once pulse is detected, the symbol flashes with each Low Battery Symbol Pulse Symbol pulse beat. Our suggestion:

Memory Average value of last 3 readings. Excessive Body Motion Detector Cuff Fitness detection Symbol The arrowhead points out the specific Risk Category that Risk Category Indicator your measurement reading fits in Please do not talk or move during measurements. This symbol appears when LCD displays average Displayed if body movement is detected during measurement, especially, the movement on the arm the blood pressure monitor is worn on. Besides, if 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 exist between the arm cuff and the arm. Notice: The measured blood pressure reading may not be accurate if the icon is displayed. Displayed if the cuff was wrapped incorrectly, which is too tight or too loose. This is the function aid in detecting if the cuff is wrapped properly. This symbol appears when there is Advanced IHB negative. This symbol appears when there is Advanced IHB positive. 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. If Advanced IHB positive symbol appears frequently, we recommend the patient to seek professional medical advice. Advanced IHB Detection feature-related Symbol

*These two symbols are only generic symbols to indicate the detection (or non-detection) of IHB, not actual heartbeat waveforms detected as a function of time.*

13 VER: A001 202203 Bluetooth Symbol LCD displays this symbol when Bluetooth is active. 14 VER: A001 202203 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 symbols. Compare the symbol of LCD display, to know the classification of your blood pressure based on American Heart Association standard (AHA 2017).

*Note When a persons systolic and diastolic pressures fall into different categories, the higher category should apply. e.g. systolic pressure 181 & diastolic pressure 99 Red category (Severe Hypertension) e.g. systolic pressure 110 & diastolic pressure 95 Red category (Mild Hypertension)

*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. 15 VER: A001 202203 Features For adults 18 and older who are not on medicine for high blood pressure, are not having a short-term serious illness, and do not have other conditions, such as diabetes and kidney disease. To determine category of risk when systolic and diastolic readings fall into two areas, use the higher of the two numbers for classification. There is an exception to the above definition of high blood pressure for people with diabetes and chronic kidney disease.

*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. 16 VER: A001 202203 Features Bluetooth Data Transmission HL858DM 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 4.2 for Android 6.0 or above, Bluetooth 4.2 for iOS 9.0 or above

*Note HL858DM 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 HL858DM 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. 17 VER: A001 202203 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 4.2 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, its 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. 18 VER: A001 202203 Features Advanced Irregular Heartbeat Detector This device equipped an Advanced IHB detection feature. The symbol Advanced IHB appears on screen indicates the specific heartbeat irregularity was detected during measurement. The Advanced IHB is designed to enhance the detectability on irregular heartbeats that arise from the internal causes of human body and tend to affect the blood pressure reading during the measurement. The algorithm of Advanced IHB can identify the specific irregular heartbeats that may cause deviated blood pressure reading. The principle of Advanced IHB is to collect and analyze pulse signal frequency from the users finger. If the specific irregular heartbeats are detected and it may affect blood pressure reading with deviation, the device will give the user a warning signal to indicate the measured blood pressure reading may be inaccurate. The specific type of heart arrhythmia or irregular heartbeat that may affects the accuracy of blood pressure measurement. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected. The detection of Advanced IHB is determined by collecting a period of pulse signals from the Advanced IHB detection area. If Advanced IHB is detected during measurement, the Advanced IHB positive symbol is displayed. If Advanced IHB positive symbol appears frequently, we recommend the patient to seek professional medical advice. And please note that the device does not replace a cardiac examination, but serves to detect specific pulse irregularity at an early stage.

*Note Sometimes the device will determine Advanced IHB positive even when it is not there. This could happen if the hand and finger move during the measuring or another rhythm problem is present. Keep the hand and finger still during the measuring. This device may not detect Advanced IHB correctly in people with pacemakers or defibrillators. We recommend you consult with your physician for proper diagnosis or seek medical advice, if Advanced IHB positive symbol appears frequently. 19 VER: A001 202203 Installing Batteries When LOW BATTERY SYMBOL reaction toward operation, please change batteries. appears on the display, or no Replace all worn-out batteries with new ones and do not mix new and used batteries. Do not mix alkaline, standard (carbon-zinc) or rechargeable (cadmium) batteries either. Such action may shorten the battery life or cause the device to malfunction. Slide the battery cover and insert 4 AA (LR6) 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. The device will keep the last measuring results after changing batteries, please reset date and time. Please replace all worn-out batteries with new ones when you are operating the Advanced IHB Detection feature, and the LOW BATTERY SYMBOL the display. appears on 20 VER: A001 202203 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, AC, 47 ~ 63 Hz, 0.4 ~ 0.2 A Output: 5 V, DC, 1A,

*Note When you use the blood pressure monitor with AC/DC adapter, do no position the device to make it difficult to disconnect the adapter plug. 21 VER: A001 202203 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. Use only the approved arm cuff for this device. Use of other arm cuffs may result in incorrect measurement result. 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 and metal ring will not touch your skin. 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 2 ~ 3 cm (approx. 1 inch) above the inner elbow. Pull the end of the cuff so that it tightens evenly around your arm, allow room for 2 fingers to fit between the cuff and your arm. Please make sure the cuff do not slip during measurement, and the arrow falls within the Proper Fit Range. When the cuff is positioned properly, press the velcro firmly against the pile side of the cuff. Sit on a chair and lay your forearm on the table so that the cuff is at the same level as your heart. 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. This monitor comes with one size of arm cuff: 9 ~ 17 (23 ~ 43 cm). 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. The device is not supposed to be used when your arm is wounded or injured. 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. If there is one of above situations, please dispose the device without reuse. Do not use this device if your wrist (Arm) has any wound or injury, especially after surgery on the wrist (Arm). Otherwise, it may cause infection at the surgical site. Please use the device after the wound has healed. 22 VER: A001 202203 Measurement Procedure Switch on the Monitor A. Put in 4 AA LR6 (1.5V) alkaline batteries. B. Press START/STOP button to switch on the monitor. The monitor will automatically turn to standby mode. Setting Year, Date and Time A. Press button ("YEAR" flashes). Press to adjust YEAR value. adjust MONTH (1, 2, 3,, 12). B. Press button ("MONTH" flashes). Use

and button to C. Adjust DATE (1, 2, 3,, 31), HOUR (1, 2, 3,.., 23, 0) and MINUTE

(00,01,02,03,.....59) as described in Step A above. D. Turning Bluetooth Feature Toggle ON/OFF User can press ON/OFF in Setup Mode.

and button to turn the Bluetooth feature

and button STANDBY MODE E. When settings are done, press button to confirm the settings. The Bluetooth feature ON Bluetooth feature OFF device turns to standby mode. Taking a Measurement

A. Before measurement, press button to select User 1 or 2. 23 VER: A001 202203 Measurement Procedure B. With the cuff wrapped around your upper arm, and place the finger of the opposite hand (index finger recommended) gently on the Advanced IHB detection area, then make sure the finger place at the correct position, press button to start measurement. All display units appear on the screen for 1.5 seconds.

*Note Do not inflate the cuff until it is wrapped around your upper arm. Please clean the finger before taking the Advanced IHB Detection measurement. Advanced IHB detection will have error result if blood pressure measurement is applied on the same arm as the finger detected. C. After all symbols disappear, the display will show 00. The monitor is Ready to Measure and will automatically inflate to the level that is right for you.

*Note!

When press the Advanced IHB detection will be both activated, if only Advanced IHB detection feature will be measured, please press the the measurement of blood pressure. key, the measurement of blood pressure and key again to stop D. As the cuff inflates, the monitor automatically determines your ideal inflation level. This monitor detects your blood pressure

) flashes at and pulse rate during inflation. The Pulse Symbol (

each pulse beat. Remain still and do not move until the entire 24 VER: A001 202203 Measurement Procedure measurement process is completed. The device will detect your pulse and determine the blood pressure.

*Note If the cuff does not stop inflating, remove the cuff at once. To stop measurement, press button. The cuff will deflate immediately after the button is pressed. If there is any error during the measurement, such as movement or hard pressure from the finger, the error message will be displayed as below:

E4 Try Again or E5 Try Again or E6 Try Again

* For details, please refer to Troubleshooting E. After the monitor has determined your blood pressure and heart rate, the cuff automatically deflates. Your systolic rate, diastolic rate, pulse, BP Category Indicator Bar and Advanced IHB Detection feature-related symbol are displayed with date and time for 1 minute.

*Note During the measurement for both blood pressure and Advanced IHB detection at the same time, users may see the result from any one measurement from the other one. Please do not move and wait for both measurement results displayed. E-1. If Advanced IHB negative measurement as normal result, the LCD display will be as below:

is determined during the E-2. If Advanced IHB positive is determined during the measurement, the Advanced IHB positive symbol will be displayed on the LCD as below:

F. The blood pressure measurment is completed and without any operation for 1 minutes, device automatically shuts off. 25 VER: A001 202203 Memory Function Storing data After each measurement, the systolic and diastolic pressure, heart rate, pulse, Risk Category Indicator Bar, Advanced IHB Detection feature-related symbol with date and time will be automatically stored. The monitor can store up to 240 memories for 2 users, and automatically replace the oldest data with new one.

*Note If only do the Advanced IHB Detection measurement, your data can Not be stored. first. Recalling data A. Press B. Press M button to enter Memory Mode. button to select User 1, or 2.

LCD displays average of last 3 measuring results C. Press M button again, LCD displays the latest measuring result. Use M or button to scroll through all stored measuring results. D. To stop reading memories, press button, and switch to Standby Mode. Erasing data A. Press

B. Press M button to enter Memory Mode. button to select User 1 or 2. C. Press and hold

and buttons at the same time, the data will be erased automatically. D. To confirm the data in the selected user has been erased, press M button and no data should appear. Note: Once deleted, your data can NOT be restored. 26 VER: A001 202203 Bluetooth Transmission To activate Bluetooth function, please make sure your Bluetooth-enabled device have downloaded APP, and follow pairing instruction. There are 2 ways to process Bluetooth Transmission if Bluetooth function is ON:

Measurement Completed:

1. After measurement completed, the device activates Bluetooth function automatically and the Bluetooth symbol will begin flashing on the screen. 2. HL858DM can pair up with Bluetooth-enabled device. To transmit measuring results to other Bluetooth-enabled. Press button for one time:

Under Standby Mode, 1. Press button into the Bluetooth mode, the Bluetooth Symbol will begin flashing on the screen. 2. While transmitting the reading to your Bluetooth-enabled Device, HL858DMetooth Symbol will remain steady on the screen. 3. HL858DM can pair up with Bluetooth-enabled device. To transmit measuring results to other Bluetooth-enabled device, please retry as mention above. Fail connection:

If HL858DMannot be connected to paired Bluetooth-enabled device over 45 seconds, LCD will display Error message Et and Bluetooth will be turned off. 27 VER: A001 202203 Bluetooth Transmission A. Date/Time Synchronization 1. The BPMs Date/Time Setting can be synchronized by Bluetooth-enabled device (e.g. smart phone) 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 BPMs date/time will be updated. B. Battery Status Check The feature provides users as a simple/convenient tool to check the battery status before measurement. Upon receiving the request from Bluetooth-enabled device either on Standby Mode or after measurement, the BPM will transmit the current battery status for users reference.

*Note Without any operation in 1 minute, the device shuts off automatically and Bluetooth Transmission OFF. Standby Mode: Segments appeared but not under BPM measuring or data transmitting. Sleeping Mode: Clear all LCD segments. 28 VER: A001 202203 Storage and Maintenance General Use Do not in any way twist the cuff. Do not press Do not drop the product and avoid any strong impacts. button if the cuff is not wrapped around your upper arm. 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 cuff and patches, due to substitution of a component different from that supplied might result in measurement error. If any suggestion or service is requested, please consult your service Do not implement the maintenance procedures for equipment during station. 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 (not directly flush, do not soak 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 / disinfection/ before use, 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. 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. 29 VER: A001 202203 Storage and Maintenance 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 Do not store the device in extremely low (less than 13/25) and high

(more than 122/50) temperature, nor in a place its humidity exceeds 93%

or dusty places. R.H. 30 VER: A001 202203 Troubleshooting SYMBOLS/SYMPTOMS CONDITIONS/CAUSES Unit does not turn on when button is pushed. Worn-out batteries. Battery polarities have been positioned incorrectly. Cuff has been placed incorrectly. Did you talk or move during measurement?

Shaking of the arm with the cuff on. Air circuit abnormality. Cuff tube may not be plugged into monitor correctly. Inflation pressure exceeding 300 mmHg. Cant determine blood pressure measurement data. If HL858DM cannot be connected to paired Bluetooth-enabled device over 45 seconds, LCD will display Error message E4 and Bluetooth will be turned off. Finger hasnt be placed on Advanced IHB detection area. Measuring Error Symbol appears when blood pressure value displayed is excessively low or high. Measuring Error Symbol Measuring Error Symbol Measuring Error Symbol Measuring Error Symbol Measuring Error Symbol INDICATION/

CORRECTION Replace them with 4 new AA (LR6) alkaline batteries. Re-insert the batteries in the correct positions. Wrap the cuff properly so that it is positioned correctly. Measure again. Keep arm steady during measurement. Check cuff connection. Measure again. Switch the unit off, then measure again. Wrap the cuff properly and keep steady. Measure again. Please press button for one time to start Bluetooth function. Keep finger gently place and well-covered on Advanced IHB detection area and measure again. Finger moved away from the detection area when the measurement has not been completed yet. Measure again and dont move away your finger before measurement completed. Finger press too hard on Advanced IHB detection area. Cold Finger and weak pulse signals Cant determine Advanced IHB measurement data. Measure again. Gently place finger on Advanced IHB detection area. Measure again. Keep finger warm and gently place on Advanced IHB detection area. Measuring Error Symbol Pulse signals could not be detected continuously by the Advanced IHB detection area for a period. Place the finger on Advanced IHB detection area and keep steady. Measure again. Measuring Error Symbol Note: If "EP" appears on the display, just return the device to your local distributor or importer. 31 VER: A001 202203 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 manufacturers 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. 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. 32 VER: A001 202203 Specifications Model Number HL858DM Measurement Method Oscillometric (inflation) Rated Range of Cuff Pressure Rated Range of Determination Measurement Range of Heart Rate 0 ~ 300 mmHg 40 ~ 280 mmHg 40~199 beats/minute Pressure: 3 mmHg Pulse: 5 % Max. Accuracy Inflation Deflation Display Memory Unit Dimensions Unit Weight Cuff Size Storage/

Transportation Environment Operation Environment Power Supply Automatic Inflation (Air Pump) Automatic Air Release Control Valve Liquid Crystal Display 240 Memory Total for 2 Users 6.08 x 4.24 x 2.37 inch (L x W x H) 154.5 x 107.8 x 60.4 mm (L x W x H) 295.8 g 5 g (10.43 oz 0.17 oz)

(Cuff and batteries excluded) UC-01: Universal cuff size: 9"~17" / 23~43 cm Temperature: -25 C ~50 C (-13 F ~ 122 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,AA LR6 (1.5V) alkaline battery x 4 2. DC 5V 1A AC/DC Adapter (Optional) Battery Life Approx. 200 Measurements Shelf life (battery) 3 years (Temperature: 20 2C; Relative humidity: 65 20%RH) Product Life 5 Years (4 times per day) Sleeping Mode Accessories Without any operation automatically shuts off. 4 AA (LR6) Alkaline Batteries, Arm Cuff with Tube, Instruction Manual, Storage Pouch for 1 minute, device RF Type Bluetooth 5.0 BLE System requirement of the Bluetooth 4.2 for Android 6.0 or above Bluetooth-enabled device Bluetooth 4.2 for iOS 9.0 or above

*The contents of this manual and the specifications of the device covered by this manual are subject to change for improvement without notice. 33 VER: A001 202203 Note Explanation of symbols :

Symbol Explanation Health & Life Information Refer to instruction manual/booklet TYPE BF Applied Part To avoid inaccurate results caused by electromagnetic interference Ingress Protection Rating Non-ionizing electromagnetic radiation 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. 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 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)

Waste of electrical and electronic equipment (WEEE) Discard the used product to the recycling collection point according to local regulations.-

Serial number YYMMXXXXXX MRI unsafe An item that is known to pose hazards in all MRI environments. 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 for: HEALTH & LIFE CO., LTD. 9F, No. 186, Jian Yi Road, Zhonghe District23553, New Taipei City, Taiwan www.healthandlife.com.tw 34 VER: A001 202203 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. CAUTION:

To assure continued FCC compliance:

Any changes or modifications not expressly approved by the grantee of this device could void the user's authority to operate the equipment. RF exposure warning 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 Changes or modifications not expressly approved by the manufacturer could void the users authority to operate the equipment HL858DM 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 Reproducibility of the blood pressure determination The laboratory Reproducibility of the BLOOD PRESSURE DETERMINATION of the AUTOMATED SPHYGMOMANOMETER shall be less than 3 mmHg (0.4 kPa). 35 VER: A001 202203 Appendix Guidance and manufacturers 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 Compliance Electromagnetic environment guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/

flicker emissions IEC 61000-3-3 Group 1 Class B Class A Complies RF energy is used only to maintain devices operation. Therefore, its RF emissions are so low that its not likely to cause any interference in nearby electronic equipment. 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. Guidance and manufacturers 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 Compliance level IEC 60601 test level Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact discharge 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 magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. 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. Power frequency

(50 or 60 Hz) magnetic field IEC 61000-4-8 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 30 A/m 50 or 60 Hz 30 A/m 50 or 60 Hz 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 AC Power port 1 KV Line to Line 0% UT; 0.5 cycle 0% UT; 0.5 cycle At 0,45,90,135,180 At 0,45,90,135,180,225

,225,270and 315.

,270and 315. 0 % UT; 1 cycles 0 % UT; 1 cycles 70 % UT; 25/30 cycles 70 % UT; 25 cycles 0 % UT; 250/300 cycle 0 % UT; 250 cycle 36 VER: A001 202203 Appendix Guidance and manufacturers 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 IEC 60601 test level Compliance level Conducted RF IEC 61000-4-6 3V rms 6V rms 3V rms 6V rms At 0.15-80 MHz At 0.15-80 MHz At ISM & Radio Amateur Freq. At ISM & Radio Amateur Freq. Radiated RF 10 V/m at 80-2700 MHz 10 V/m at 80-2700 MHz IEC 61000-4-3

(Proximity fields from RF wireless communications equipment IEC 61000-4-3) 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 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 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 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. 37 VER: A001 202203 Appendix Test specifications for enclosure port immunity to RF wireless communications equipment. Test frequency

(MHz) Modulation IMMUNITY TEST LEVEL

(V/m) 385 450 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 Pulse modulation 18 Hz a) FM 5 kHz deviation 1kHz sine b) Pulse modulation 217 Hz a) Pulse modulation 18 Hz a) 28 Pulse modulation 217 Hz a) Pulse modulation 217 Hz a) Pulse modulation 217 Hz a) 27 28 9 28 28 9 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. 38 VER: A001 202203 Blood Pressure Diary Date Time Systolic / Diastolic Date Time Systolic / Diastolic Date Time Systolic / Diastolic Date Time Systolic / Diastolic Date Time Systolic / Diastolic Date Time Systolic / Diastolic Date Time Systolic / Diastolic Date Time Systolic / Diastolic Date Time Systolic / Diastolic Date Time Systolic / Diastolic Before After Pulse Before After Pulse Before After Pulse Before After Pulse Before After Pulse Before After Pulse Before After Pulse Before After Pulse Before After Pulse Before After Pulse Meal Meal Meal Meal Meal Meal Meal Meal Meal Meal P/N323103681 VERA001 202203 39 VER: A001 202203

Label & Location Back View Automatic Upper Arm Blood Pressure Monitor Model No. HL858DM Power:

1. DC 6V, AA LR6 (1.5V) Alkaline Battery x 4 2. DC 5V 1A AC/DC Adapter: FranMar International, FRM06-S05-UU (optional) Rated Range of Cuff Pressure0 ~ 300 mmHg FCC ID:2ABTAHNL85DM1

(XX)XXXXXXXXXXXXXX

(XX)YYMMXXXXXX Manufacturer for HEALTH & LIFE CO., LTD. 9F, No. 186, Jian Yi Road, Zhonghe District 23553, New Taipei City, Taiwan Made in China 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. Date of Manufacture : YYYY-MM

Automatic Upper Arm Blood Pressure Monitor Label for HL858DM (US) Automatic Upper Arm Blood Pressure Monitor Model No. HL858DM Power:

1. DC 6V, AA LR6 (1.5V) Alkaline Battery x 4 2. DC 5V 1A AC/DC Adapter: FranMar International, FRM06-S05-UU (optional) Rated Range of Cuff Pressure0 ~ 300 mmHg FCC ID:2ABTAHNL85DM1

(XX)XXXXXXXXXXXXXX

(XX)YYMMXXXXXX Manufacturer for HEALTH & LIFE CO., LTD. 9F, No. 186, Jian Yi Road, Zhonghe District 23553, New Taipei City, Taiwan Made in China 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. Date of Manufacture : YYYY-MM

fyb Zo miclellia x Life The Art of Invention FCC ID: 2ABTAHNL85DM1 Date: June 1, 2022 Federal Communications Commission Authorization and Evaluation Division Confidentiality Request Pursuant to Sections 0.457 and 0.459 of the Commissions Rules, the Applicant Hereby requests KolavilelclalareUmaacr-agntslarmelmelaicelgaar-lalolam-ranelanl or-lenalarmanlicw-\e) oll (erciacelaw-tweleialtatsve Mm el=) (ele Type of Confidentiality Requested Exhibit Permanent Block Diagrams

(1 Short Term External Photos C] Short Term Internal Photos Permanent Operation Description/Theory of Operation L] Permanent Parts List & Placement/BOM L] Permanent Tune-Up Procedure Permanent Schematics CL] Short Term Test Setup Photos LC] Short Term Users Manual The above materials contain trade secrets and proprietary information not customarily Released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457, disclosure of this Application and all accompanying documentation will not be made before the date of the Grant for this application. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public Sincerely, Albert Lee / President Health & Life Co., Ltd.

Health Life The Art of Invention June 1, 2022 Dl -vet-le-lulelamelmetvinalelarsctiiela We Name: Health & Life Co., Ltd. Address: OF, No. 186, Jian Yi Road, Zhonghe District, New Taipei City 23553, Taiwan City: New Taipei City 23553 Country: Taiwan Declare that:

Name Representative of agent: Stanley Wu Agent Company name: DEKRA Testing and Certification Co., Ltd Address: No. 26, Huaya 1% Rd., Guishan Dist., City: Taoyuan City 33341, Country: Taiwan. sw-lShare)apactemaom-])) Vaio] m@clanii(e-ld(elameymuat-mie) (oi uiat-melcore [eran )) Product Name: Automatic Upper Arm Blood Pressure Monitor Model: HL858DM FCC ID: 2ABTAHNL85DM1 Trademark: Health & Life on our behalf. Albert Lee / President Health & Life Co., Ltd.