SEJOY DBP-82A5B Wrist Type Fully Automatic Blood Pressure Monitor Owner’s Manual

DBP-82A5B Wrist Type Fully Automatic Blood Pressure Monitor

Owner’s Manual
Wrist-type Fully Automatic Blood Pressure Monitor
Model DBP-82A5B
Wrist Type

Document No.:JDBP-A504-053 Version: Z Date of Issue: 2022.03.15
Contact Information
The lay operator or lay responsible or ganization should contact the manufacturer or the representative of manufacturer. -for assistance,if needed,in setting up,using or maintaining the product,or -to report unexpected operation or events. Manufactured by JOYTECH Healthcare Co.,Ltd. No.365, Wuzhou Road,Yuhang Economic Development Zone,Hangzhou City,311100 Zhejiang,China Email: info@sejoy.com Telephone: +86-571-81957767 Fax: +86-571-81957750

Contents

1

Safety Notice ……………………………………………………… 02 Unit Illustration ………………………………………………… 09 Important Testing Guidelines ………………………………. 12 Quick Start ……………………………………………………….. 13 Unit Operation ………………………………………………….. 15
Battery Installation ………………………………………….. 15 System Settings ……………………………………………….. 16 Applying The Wrist Monitor ……………………………… 19 Testing …………………………………………………………… 21 Power Off ……………………………………………………….. 26 Memory Check and Last 3 Tests Average……………….. 27 Memory Deletion ……………………………………………… 29 Low Battery Indicator ……………………………………… 30 Troubleshooting ……………………………………………… 33
Blood Pressure Information …………………………………. 34 Blood Pressure QA …………………………………………… 38 Maintenance ……………………………………………………… 40 Specifications ……………………………………………………. 44 Warranty ………………………………………………………….. 48 Electromagnetic Compatibility Information……………. 49 Addition Notes ……………………………………………………. 54

Safety Notice

3

Important Instructions Before Use 1. Do not confuse self-monitoring with self- diagnosis. Blood
pressure measurements should only be interpreted by a health professional who is familiar with your medical history. 2. Contact your physician if test results regularly indicate abnormal readings. 3. If you are taking medication, consult with your physician to determine the most appropriate time to measure your blood pressure. NEVER change a prescribed medication without first consulting with your physician. 4. Individuals with serious circulation problems may experience discomfort. Consult your physician prior to use. 5. For persons with irregular or unstable circulation resulting from diabetes, liver disease, arteriosclerosis or other medical conditions, there may be variations in blood pressure values measured at the wrist versus at the upper arm. Monitoring the trends in your blood pressure taken at either the arm or the wrist is nevertheless useful and important. 6. People suffering from vascular constriction, liver disorders or diabetes, people with cardiac pacemakers or a weak pulse, and women who are pregnant should consult their physician before measuring their blood pressure themselves. Different values may be obtained due to their condition. 7. People suffering from arrhythmias such as atrial or ventricular premature beats or atrial fibrillation only use this blood pressure monitor in consultation with your doctor. In certain cases oscillometric measurement method can produce incorrect readings. 8.Too frequent measurements can cause injury to the patient due to blood flow interference. 9.The cuff should not be applied over a wound as this can cause further injury.

Safety Notice

2

Thank you for purchasing the DBP-82A5B Blood Pressure Monitor. The unit has been constructed using reliable circuitry and durable materials. Used properly, this unit will provide yeas of satisfactory use.

Indications for use: The Wrist-type Fully Automatic Digital

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blood adults

and

All functions can be used safely and values can be

read out in one LCD DISPLAY. Measurement position is on

adult upper wrist only.

The PATIENT is an intended OPERATOR.

Blood pressure measurement determined with this device are equivalent to those obtained by a trained observer using the cuff/ stethoscope auscultation method, within the limits prescribed by the Recognized Consensus Standard(IEC 80601-2-30) for electronic sphygmomanometers.

Precautions to Ensure Safe, Reliable Operation

1. Do not drop the unit. Protect it from sudden jars or shocks.

2. Do not insert foreign objects into any openings.

3. Do not attempt to disassemble the unit.

4. 5.

Do not crush the pressure If the unit has been stored

cuff. at temperatures

below

0

,

leave

it

in a warm place for about 15 minutes before using it.

Otherwise, the cuff If the unit has been

may not stored at

inflate properly. temperatures above

40

,leave

it in a cool place for about 15 minutes before using it. Otherwise,

the cuff may not inflate properly.

7. Do not store the unit in direct sunlight, high humidity or dust.

8.To avoid any possibility of accidental strangulation, keep this

unit away from children and do not drape tubing around your

neck.

9.Ensure that children do not use the instrument unsupervised;

some parts are small enough to be swallowed.

10.Some may get a skin irritation from the cuff taking frequent

readings over the course of the day, but this irritation typically

goes away on its own after the monitor is removed.t

Safety Notice

4

10.DO NOT attach the cuff to a limb being used for IV infusions or any other intravascular access, therapy or an arterio-venous (AV) shunt. The cuff inflation can temporarily block blood flow, potentially causing harm to the patient.
11.The cuff should not be placed on the arm on the side of a mastectomy. In the case of a double mastectomy use the side of the least dominant arm.
12.Pressurization of the cuff can temporarily cause loss of function of simultaneously used monitoring equipment on the same limb.
13.A compressed or kinked connection hose may cause continuous cuff pressure resulting in blood flow interference and potentially harmful injury to the patient.
14.Check that operation of the unit does not result in prolonged impairment of the circulation of the patient.
15. Product is designed for its intended use only. Do not misuse in any way.
16. Product is not intended for infants or individuals who cannot express their intentions.
17. Prolonged over-inflation of the bladder may cause ecchymoma of your arm.
18. Do not disassemble the unit or wrist cuff. Do not attempt to repair. 19. Use only the approved wrist cuff for this unit. Use of other wrist
cuffs may result in incorrect measurement results. 20. The system might produce incorrect readings if stored or used out-
side the manufacturer’s specified temperature and humidity ranges. Make sure to store the blood pressure monitor, children, pets and pests are outside of accessible range.

Safety Notice

5 Safety Notice

6

21. Do not use the device near strong electrical or electromagnetic fields generated by cell phones or other devices, they may cause incorrect readings and interference or become interference source to the device. 22. Do not mix new and old batteries simultaneously. 23. Replace batteries when Low Battery Indicator” “appears on
screen. Replace both batteries at the same time. 24. Do not mix battery types. Long-life alkaline batteries are recommended. 25. Remove batteries from device when not in operation for more than 3 months. 26. Do not insert the batteries with their polarities incorrectly aligned. 27. Dispose batteries properly; observe local laws and regulations.

Advising operator that Instruction manual/ Booklet

must be consulted.

29.Do not use the device during transport vehicles for influencing measurement accuracy,

such as patient transport in an ambulance or helicopter.

30.Contains small parts that may cause a chocking hazard if swallowed by infants.

31.the blood pressure monitors equipped with bluetooth(BT) module is only transmit historical

blood pressure (BP) from the subject device to a user-supplied digital device, and is not intended

for active patient monitoring.

WARNING SIGNS AND SYMBOLS USED Keep off Sunlight

Type BF Equipment

IP22
MR

Instructions For Use MUST be Consulted
Discard the used product to the recycling collection point according to local regulations
The Bluetooth® Smart word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by JOYTECH Healthcare Co.,Ltd. IP22 indicate dustproof and waterproof grade. Number 2 indicate that Protected against solid foreign objects of 12.5 mm and greater; Number 2 Protection against vertically falling water drops when ENCLOSURE tilted up to 15q .
Magnetic Resonance unsafe

Safety Notice

7

Federal Commulcation Commission (FCC) Interference Statement

1.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. Please note that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 2.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:
–Reorient or relocate the receiving antenna.
–Increase the separation between the equipment and 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. 3.This equipment complies with radio frequency exposure limits set forth by the FCC for an uncontrolled environment. 4. This device must not be co-located or operating in conjunction with any other antenna or transmitter.

Safety Notice

8

5.Essential performance:
Electrosurgery interference recovery
Limits of the error of the manometer Reproducibility of the BLOOD PRESSURE DETERMINATION

Refer 202.6.2.101 IEC 80601-2-30 Refer 202.12.1.102 IEC 80601-2-30 Refer 201.12.1.107 IEC 80601-2-30

Unit Illustration

Monitor Unit
“memory switch” Button

LCD
“SET” Button

Wrist Cuff

“ON/OFF” Button “MEM” Button

Battery cover

9 Unit Illustration Display

Charge Indication

Group Time/Date

WHO Blood Pressure Classification Indicator

10
Systolic Blood Pressure

Arm Shake Indicator Irregular Heartbeat Indicator Last 3 Tests Average Bluetooth Indicator
MAM Indicator

Pulse Rate Heart Rate Indicator

Diastolic Blood Pressure

Unit Illustration Contents
Owner’s Manual
Wrist-type Fully Automatic Blood Pressure Monitor Model DBP-82A5B
Wrist Type
2.Owner’s Manual

1.Monitor Unit

11 Important Testing Guidelines

12

1. Avoid eating, exercising, and bathing for 30 minutes prior to testing.
2. Sit in a calm environment for at least 5 minutes prior to testing. 3. Do not stand while testing. Sit in a relaxed position while
keeping your wrist level with your heart. 4. Avoid speaking or moving body parts while testing. 5. While testing, avoid strong electromagnetic interference such
as microwave ovens and cell phones. 6. Wait 3 minutes or longer before re- testing. 7. Try to measure your blood pressure at the same time each day
for consistency. 8. Test comparisons should only be made when monitor is used
on the same wrist , in the same position, and at the same time of day. 9. This blood pressure monitor is not recommended for people with severe arrhythmia. 10.Do not use this blood pressure monitor if the device is damaged.

3.Plastic Storage Case

Quick Start
1. Install batteries. (See Figure A )

13 Quick Start

14

4. Sit in a comfortable position and place wrist level with heart. (See Figure D)
5. Press ” ON/OFF” button to start testing. (See Figure E)

Figure A 2. Remove clothing from the wrist area . (See Figure B) 3. Rest for several minutes prior to testing. Wrap cuff around
left wrist . (See Figure C)
1-2cm (0.4-0.8 ”)

Figure D

Figure E

Figure B
Unit Operation
Battery Installation
Slide battery cover off as indicated by arrow. Install 2 new AAA alkaline batteries according to polarity. Close battery cover.

15 Unit Operation

16

System Settings With power off, press and hold ” memory switch” button to actuate system setting .The
Memory Group icon flashes. 1. Secect memory Group
Wile in the System Setting mode you may accumulate test rescuts into 2 diffterent groups. This allows multiple users to save individual test results ( up to 100 memories per group). Press “MEM” button to choose a group setting. The test results will automatically store in each selected group.

Note: 1) Replace batteries when Low Battery Indicator ” ”
appearsonscreen. 2) Batteries should be removed from device when not in
operation for an extended period of time.

2. Time/Date setting
Press SET button again to set the Time/Date mode. Set the year first by
adjusting the “MEM” button. Press ” SET ” button again to confiom curret month.
Continue setting the day, hour and minute in the same way. Every time the “SET” button is pressed, it will lock in your seletion and continue in succession ( month, day,hour, minute,12/24 hours,EU/US)

Unit Operation

17 Unit Operation

18

3. Voice Setting Press “SET” button to enter voice setting mode. Set the voice format ON or OFF by pressing the “MEM” button.

6. Three continuous measurement settings Press “SET” button to enter Settings of cuff keeping level with heart .Set the Function of cuff keeping level with heart ON or OFF by pressing
the ” MEM” button .

4. Volume Settings Press “SET” button to enter volume setting mode. Set the voice volume by adjusting the “MEM” button . Smaller ” ” is for lower volume. There are six volume levels.
5. Settings of cuff keeping level with heart Press “SET” button to enter Settings of cuff keeping level with heart .Set the Function of cuff keeping level with heart ON or OFF by pressing the ” MEM” button .

7. Save Settings While in any setting mode, press ” ON/OFF” button to turn the unit off. All information will be saved.
Note: Unit will automatically save all information and shut off if left idle for 3 minutes.

Unit Operation
Applying The Wrist Monitor
Do not apply over clothing. If wearing a long sleeved shirt, be sure to roll sleeve back to forearm.
Apply monitor to wrist as illustrated. Tighten cuff firmly as not to wiggle.

19 Unit Operation

20

Do not stand while testing. Sit in a comfortable position with back supported, feet flat on the floor with legs uncrossed. Place middle of the cuff at the level of the right atrium of the heart.

1-2cm (0.4-0.8 ”)

Unit Operation

21 Unit Operation

22

Testing
1. Power On
Press “ON/OFF” button to turn on the unit . The LCD screen will appear for one second as unit performs a quick diagnosis. A voice tone will indicate when unit is ready for testing.

2.Make sure the wristband is level with the heart
When the wristband does not keep level with the heart, the LCD screen displays POS and flashes, as shown in the following interface (If there is a voice function, it will “ding”, or the buzzer “di di” prompts the user current location error )

Note: Unit will not function if residual air from previous testing is present in cuff. The LCD will flash ” ” until pressure is stabilized.

When the wrist strap and the heart remain level, enter the zero grasp, the LCD screen will display as follows interface:

Unit Operation

23

3. Testing
After cuff inflation, air will slowly rise as indicated by the corresponding cuff pressure value. A flashing ” ” will appear simultaneously on screen signaling heart beat detection.

Note: Remain relaxed during testing. Avoid speaking or moving body parts.
4. Result Display (1)Continuous measurement mode is not enable(Normal Function)
The screen will display measurements for systolic and diastolic blood pressure with voice broadcast. An indicator representing the current measurement will appear next to the corresponding WHO Classification.

Unit Operation

24

(2)Continuous measurement mode is enable(MAM Function)
Start the continuous measurement mode. Before the end of the third measurement, the corresponding data will be displayed at the end of each measurement, and a 1-minute countdown will be performed on the screen. At the end of the third measurement, if there is a significant deviation in one of the three data sets, the next set of tests will be performed and the third measurement results will be displayed. Before that, if the difference between the three sets of data was too large, the error was reported directly, while the screen ran a 1-minute countdown to the next measurement. If three consecutive measurements are wrong, the sphygmomanometer will automatically shut down. If three sets of normal data are measured under correct operation, the third correct data is not displayed on the screen, and the average value of the three times is displayed directly. Indicators representing the current measure will appear next to the corresponding WHO classification.

Interval countdown

Number of measurement

Unit Operation

25 Unit Operation

26

Note: Refer to Page 35~36 for detail WHO Blood Pressure Classification Information.
Irregular Heartbeat Indicator If the monitor detects an irregular heart rhythm two or more times during the measuring process, the Irregular Heartbeat
Symbol ” IHB “appears on screen along with measurement
results. Irregular heartbeat rhythm is defined as rhythm that is either 25% slower or faster than the average rhythm detected while measuring systolic blood pressure and diastolic blood pressure. Consult your physician if the Irregular Heartbeat
Symbol ” IHB ” frequently appears with your test results.

Memory Check and Last 3 Tests Average
With power off, press the “MEM” button to activate screen display. After the unit performs a self diagnosis, the screen will display the average test results from the last 3 readings of the last group used . The ” ” symbol will appear along with the corresponding WHO Blood Pressure Indicator. To check the average results from other groups, select the desired group first prior to activating the “MEM” button in the off position (See “Select Memory Group” on page 16).

Power Off
The ” ON/OFF” button can be pressed to turn off the unit in any mode. The unit can turn off the power itself about 3 minutes no operation in any mode.
Safety Precaution: If pressure in cuff becomes too extreme while testing, press the ” ON/OFF” button to turn power off The cuff pressure will rapidly dissipate once the unit is off.

Press the ” MEM” button again, you may check past test results. Upon activating test results, you can press the” MEM”button to scroll through all test results stored in memory. The LCD will display the last memory as NO: 01 reading. (“MEM”button means turn forward,)

Unit Operation

27 Unit Operation

28

While reviewing the readings, the MAM average icon may appear on the screen. Press the “Set” button to review individual readings that make up the MAM average.

Note: Past test results will only be displayed from the most recently used memory group. To check past test results in other
memory groups, you must Press corresponding button or select the desired group and then turn monitor off . ( See Select Memory Group on Page 16. )
Note: If the first memory data of the current memory group is measured by the MAM, the LCD will show “MAM” and” AVG “.
Note: If the last 3 readings were a MAM average, then the MAM average will be displayed.
Note:Memory averaging function will only average individual readings.

Unit Operation

29 Unit Operation

30

Memory Deletion
Memory for a selected group may be deleted while in Memory Check mode. Press and hold the” MEM” button and ” on/off” button 3 second for approximately 3 seconds to delete all memory records from the selected group with voice broadcast ” Memory Clear ” . And then transfer into testing mode. Press the ” ON/OFF” button to turn the unit off.

Low Battery Indicator

The unit will broadcast ” Low Battery”when battery life is depleting

and unable to inflate cuff for testing. The ”

” appears

simultaneously for approximately 5 seconds prior to shutting off.

Replace batteries at this time. No memory loss will occur

throughout this process.

Note: Memory cannot be recovered once it has been deleted.

Arm Shake Indicator
If there is arm movement during the measurement, the ”

” icon

may flash. Indicates that the measurement results may be inaccurate,

and the situation will be recorded at the end of the measurement as a

reminder.

Unit Operation

31 Unit Operation

32

Static Pressure Measurement
In the power down state, press and hold the ” ON/OFF “button 3 second, and theninstall the batteries. until the LCD screen is full, release the “ON/OFF” button. When the LCD screen displays the double zero, the bloodpressure meter is in static state. Software version is displayed 01 is a software version in the figure.

-Pairing your monitor with a Smart Device 1. Open the “blood pressure monitor” and follow the pairing instructions shown on your smart phone.
The date and time on your monitor will automatically be set when you pair it with your smart device.

2. Confirm that your monitor is connected successfully. When your monitor is connected successfully to your smart phone, the “Boo” symbol flshes.

Note: Only Service personnel permitted to access to this mode, the mode unavailable in normal use.
Bluetooth connection
-Using for the first time
1. Download the free “JoyHealth” App: On your mobile phone or table go to www.sejoy.com. 2.Open the App on your phone or tablet. If requested, you should enable Bluetooth on your device. You can enable Bluetooth under the Settings menu on your smart phone or table. 3. Create a new user login, or login with your existing user name and password. 4. Selection device “Blood pressure monitor”.

3. Press the BP [ON/OFF] button to turn your monitor off.
-Transfer your readings 1. As soon as your measurement is complete, open the app on your smart phone to transfer
your reedings. Notr: On the paired smartphone, Bluetooth must be enabled. 2. You can view your blood pressure readings on the app.

Unit Operation

33 Blood Pressure Information

34

Troubleshooting

Abnormal phenomenon

Cause analysis
The armband is tied too tight or too loose, Or the arm strap is tied incorrectly;

Processing method Roll the armband correctly

Blood Pressure
Blood pressure is the force of blood pushing against the walls of arteries. It is typically measured in millimeters of mercury

Abnormal sphygmomanometer

Move the arm during measurement orElectronic sphygmomanometer
Speaking, nervous or emotional during measurement

Stay quiet, keep your arm steady, and do not move the monitor
Instead of talking, take deep breaths to calm your mood and relax your body

Incorrect measurement posture

Adjust posture, see “Blood pressure gauge Wearing”

There is interference in charging process or improper operation in measuring process

See operation Instructions.

The following table shows the error signs that may occur during measurement, possible causes and handling methods. Please measure again using the correct method

(mmHg.) Systolic blood pressure is the maximum force exerted against blood vessel walls each time the heart beats. Diastolic blood pressure is the force exerted on blood vessels when the heart is resting between beats.
An individual’s blood pressure frequently changes throughout the course of a day. Excitement and tension can cause blood

Error display
Er1

The cause of the problem Can’t detect high and low pressure

The solution Please fasten the cuff before measuring

pressure to rise, while drinking alcohol and bathing can lower blood pressure. Certain hormones like adrenaline (which your

Er2

Cuff too loose or loose

Please fasten the cuff before measuring

body releases under stress) can cause blood vessels to constrict,

Er3

Improper compression caused by arm or body movement

Hold the arm or body still and measure again

leading to a rise in blood pressure.

Er4 Er5 Er6 Er0

The pressure exceeds 300mmHg
The pressure exceeds 15mmHg for 3 minutes
Blood pressure measurements were out of range Four sets of results were measured that did not meet MAM requirementsr

Please fasten the cuff before measuring
Check whether the cuff is knotted or the vent valve is blocked. If the problem persists, contact the manufacturer
Please tighten and measure and measure again .If you cannot solve the problem,please contact the meanufacturer
Please tighten and measure and measure again .If you cannot solve the problem,please contact the meanufacturer

If these measuring numbers become too high, it means the heart

is working harder than it should.

200

Upper curve : systolic blood pressure

Lower curve: diastolic blood pressure

150

mmHg

Battery dead

Replace the battery or connect the power adapter (if any).

Note: If you cannot solve the abnormal situation by yourself, you can consult the manufacturer or the manufacturer’s designated unit by phone. It is forbidden to disassemble and repair without permission. If necessary, professional maintenance personnel can ask the manufacturer for the list of components and circuit schematic diagram.

100

50

6

12

18

24

Time of day

Example: fluctuation within a day (male, 35 years old)

Blood Pressure Information

35 Blood Pressure Information

36

WHO Blood Pressure Classification Indicator
The DBP-8297B is equipped with a classification indicator based on established guidelines from the World Health Organization. The chart below (color coded on monitor unit) indicates test results.
Severe Hypertension Moderate Hypertension Mild Hypertension High-n ormal Normal Optimal
Normal
Bluetooth Connection Identifier (only DBP-82A5B)
: Blood Pressure Classification Indicator

Health Reminder
Hypertension is a dangerous disease that can affect the quality of life. It can lead to a lot of problems including heart failure, kidney failure, and cerebral hemorrhaging. By maintaining a healthy lifestyle and visiting your physician on a regular basis, hypertension and relative diseases are much easier to control when diagnosed in the early stages.
Systolic ( mmHg )

180 160 140 130 120

Severe Hypertension Moderate Hypertension Mild Hypertension High-normal Normal Optimal

80 85 90 100 110

Diastolic ( mmHg )

Blood Pressure Information

37 Blood Pressure QA

38

Note: Do not be alarmed if an abnormal reading occurs. A better indication of an individual’s blood pressure occurs after 2-3 readings are taken at the same time each day over an extended period of time. Consult your physician if test results remain abnormal.

Q: What is the difference between measuring blood pressure at home or at a professional healthcare clinic?
A: Blood pressure readings taken at home are now seen to give a more accurate account as they better reflect your daily life. Readings can be elevated when taken in a clinical or medical environment. This is known as White Coat Hypertension and may be caused by feeling anxious or nervous.

Note: Abnormal test results may be caused by: 1. Improper cuff placement
Make sure cuff is snug-not too tight or too loose. 2. Improper body position
Make sure to keep your body in an upright position. 3. Feeling anxious or nervous
Take 2-3 deep breaths, wait a few minutes and resume testing.

Blood Pressure QA

39 Maintenance

40

Q: What causes different readings? A: Blood pressure varies throughout the course of a day. Many
factors including diet, stress, cuff placement, etc. may affect an individual’s blood pressure. Q: Should I apply the cuff to the left or right wrist? What is the difference? A: Either wrist can be used when testing, however, when comparing results, the same wrist should be used. Testing on your left wrist may provide more accurate results as it is located closer to your heart. Q: What is the best time of day for testing? A: Morning time or any time you feel relaxed and stress free.

1. Avoid dropping, slamming, or throwing the unit. 2. Avoid extreme temperatures. Do not use outdoors.

Maintenance

41 Maintenance

42

3. When cleaning the unit, use a soft fabric and lightly wipe with

mild detergent. Use a damp cloth to remove dirt and excess detergent.

5. Do not use petrol, thinners or similar solvents.

4. Cuff Cleaning: Do not soak cuff in water! Apply a small amount of rubbing alcohol to a soft cloth to clean cuff’s surface. Use a damp cloth (water- based) to wipe clean. Allow cuff to dry naturally at room temperature. The cuff must be cleaned and disinfected before use between different users.

6. Remove batteries when not in operation for an extended period of time.

Maintenance

43

7. Do not disassemble product.

8. It is recommended the performance should be checked every 2 years.
9. Expected service life: Approximately three years at 10 tests per day.
10.No service and maintenance while it is in use and maintenance only be performed by service personnel. Service and maintenance require parts, repair, technical support will be provided.

Specifications

44

Product Description Model Display Measurement Method
Measurement Range
Pressurization Memory
Function

Wrist-type Fully Automatic Blood Pressure Monitor

DBP-82A5B

LCD Digital Display Size:47mm x 38mm

Oscillometric Method

Systolic Pressure Diastolic Pressure Pressure Pressure

60mmHg260mmHg 40mmHg200mmHg 0mmHg299mmHg ±3mmHg

Pulse Pulse

30 ~ 180 Beats/Minute ±5%

Automatic Pressurization

2X100 Memories in Tow Groups with Date and Time Irregular Heartbeat Detection WHO Classification Indicator

Last 3 Results Average Low Battery Detection

Voice Automatic Power-Off

Specifications

45 Specifications

46

Function

Backlight Bluetooth

Continued

Modulation Type Version

GFSK 5.0.1 BT Signal mode

Power Source

2 Alkaline Batteries Size AAA

Bluetooth

Operation frequency 2.4GHz(2400~2483.5MHz)

Battery Life

Approximately 2 months at 3 tests per day

Antenna gain

0 dBi

Unit Weight Unit Dimensions

Approx. 113g ( Excluding Battery) Approx. 86mm×64mm×30mm(L x W x H)

Cuff Circumference

Fits wrist circumference 13.5-21.5 cm(5.3″-8.5″)

Temperature 10 ~ 40 (50~104 )

Operating Environment Humidity

15%~80%RH

Pressure

800hPa~1050hPa

Storage Environment

Temperature Humidity

-25~55 (-13~131 ) 93% RH

Temperature -25~55 (-13~131)

Transport Environment

Humidity

93% RH

Ingress Protection Rating IP 22

Classification

Internal Powered Equipment Type BF

Bandwidth

2.0 MHz

Specifications are subject to change without notice.

Safety Standard(included but not limited): 1. IEC 80601-2-30, medical electrical equipment – part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers. (Cardiovascular) 2. ISO 81060-2, non-invasive sphygmomanometers – part 2: clinical validation of automated measurement type.(Cardiovascular) 3. AAMI / ANSI ES 60601- 1: 2005/(R)2012 and C1: 2009/® 2012 and, a2:2010/(r)2012 (consolidated text) medical electrical equipment — part 1: general requirements for basic safety and essential performance 4. AAMI/ANSI/IEC 60601-1-2, Medical Electrical Equipment — Part 1-2: General Requirements For Basic Safety And Essential Performance — Collateral Standard: Electromagnetic Disturbances – – Requirements And Tests (General II ( ES/ EMC)).
5. IEC 60601-1-11, medical electrical equipment – part 1-11: general requirements for basic safety and essential performance collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

Specifications

47

Correct Disposal of This Product (Waste Electrical & Electronic Equipment)
This marking shown on the product indicates that it should not be disposed with other household waste at the end of its life. To prevent potential harm to the environment or to human health, please separate this product from other types of wastes and recycle it responsibly. When disposing this type of product, contact the retailer where product was purchased or contact your local government office for details regarding how this item can be disposed in an environmentally safe recycling center. Business users should contact their supplier and check the terms and conditions of the purchasing agreement. This product should not be mixed with other commercial wastes for disposal. This product is free of hazardous materials.

Warranty

48

The Blood Pressure Monitor is guaranteed for 2-year from the date of purchase. If the Blood Pressure Monitor does not function properly due to defective components or poor workmanship, we will repair or replace it freely. The warranty does not cover damages to your Blood Pressue Monitor due to improper handling. Please contact local retailer for details.

Electromagnetic Compatibility Information
The device satisfies the EMC requirements of the international standard IEC 60601-1-2. The requirements are satisfied under the conditions described in the table below. The device is an electrical medical product and is subject to special precautionary measures with regard to EMC which must be published in the instructions for use. Portable and mobile HF communications equipment can affect the device. Use of the unit in conjunction with non-approved accessories can affect the device negatively and alter the electromagnetic compatibility. The device should not be used directly adjacent to or between other electrical equipment.
Table 1
Guidance and declaration of manufacturer-electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Emissions test

Compliance

Radiated emission CISPR 11

Group 1, ClassB

Electromagnetic environment -guidance
The device uses RF energy only for its internal function. Therefore, its emissions are very low and are not likely to cause any interference in nearby electronic equipment.

49

Conducted emission CISPR 11 N/A

Harmonic emissions

IEC 61000-3-2

N/A

Voltage fluctuations/

flicker emissions IEC 61000-3-3

N/A

Electromagnetic Compatibility Information

Table 2

Guidance and declaration of manufacturer-electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

IMMUNITY test

IEC 60601 test level

Compliance level

Electromagnetic environment -guidance

Electrostatic discharge (ESD) IEC 61000-4-2
Electrostatic transient/burst IEC 61000-4-4
Surge IEC 61000-4-5

± 8 kV contact ±2 kV,±4 kV, ±8 kV, ±15 kV air
± 2 kV for power supply lines ± 1 kV for input/output lines
± 1 kV differential mode ± 2 kV common mode

± 8 kV

Floors should be wood, concrete

contact

or ceramic tile. If floors are

±2 kV,±4 kV, covered with synthetic material,

±8 kV,

the relative humidity should be

±15 kV air at least 30 %.

N/A

N/A

< 5% UT (>95% dip in UT) for 0.5 cycle

Voltage dips, short interruptions and voltage variations on p-

40% UT (60% dip in UT) for 5 cycle

ower supply in- 70% UT

put lines

(30% dip in

UT) for 25 IEC 61000-4-11 cycle
<5% UT

(>95% dip in UT) for 5 secretary

Power frequency (50/60 Hz) magnetic field

30 A/m; 50Hz or 60Hz

IEC 61000-4-8

N/A

30 A/m; 50Hz or 60Hz

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

50

Electromagnetic Compatibility Information

51

Table 2(continued)

Guidance a nd d eclaration o f manufacturer-electromagnetic immunity

The d evice i s intended f or u se in the e lectromagnetic e nvironment specified b elow. The c ustomer o r the u ser o f the d evice s hould a ssure that it is u sed in s uch a n environment.

IMMUNITY test

IEC 6 0601 test level

Compliance level

Electromagnetic e nvironment -guidance

Radiated RF EM fields
IEC 61000-4-3

3V/m or 10 V/m 80MHz-2.7 Ghz 80%AM at 1kHz

3V/m or 10 V/m 80MHz-2.7 Ghz 80%AM at 1kHz

Portable a nd m obile R F communications equipment should b e used n o closer to a ny part of the d evice, including c ables, than the recommended s eparation d istance calculated f rom t he e quation a pplicable to the frequency o f the transmitter. Recommended s eperation d istance 8 0 MHz to 8 00 M Hz 8 00 M Hz to 2 .7 G hz w here P is the m aximum o utput power rating o f the transmitter in w atts (W) according to the transmitter m anufacturer and d i s the recommended s eparation d istance in metres (m). Field s trengths from f ixed R F transmitters, as d etermined b y an electromagnetic s ite s urvey, a s hould b e less than the c ompliance level in e ach frequency r ange. Interference m ay o ccur in the v icinity o f equipment m arked w ith the following s ymbol:

Conducted disturbances Induced by RF fields IEC 61000-4-6

3 V in 0.15 MHz- 80 MHz 6 V in ISM and/or amateur radio bands between 0.15 MHz and 80 MHz 80 % AM at 1kHz

3 V in 0.15 MHz- 80 MHz 6 V in ISM and/or amateur radio bands between 0.15 MHz and 80 MHz 80 % AM at 1kHz

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 seperation distance 80 M Hz to 800 M Hz 800 M Hz to 2.7 Ghz where P i s the maximum output power rating of the transmitter in watts (W) according to the transm- itter manufacturer and d is the recommended separation distance in metres (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. Interference may occur in the vicinity of equipment marked with the following symbol:

Electromagnetic Compatibility Information

52

Table 3

Guidance and declaration of m anufacturer-electromagnetic immunity

Nowadays, m any R F wireless equipments have being used in various healthcare

locations where medical equipment and/or systems

are used. When they are

used in close proximity to medical equipment and/or systems, the medical

equipment and/or systems’ basic safety and essential performance may be

affected. Arm-type Fully Automatic Digital Blood Pressure Monitor

has been

tested with the immunity test level in the below table and meet the related

requirements of IEC 60601-1-2:2014. The customer and/or user should

help

keep a minimum distance between RF wireless communications equipment and

this m edical equipment and/or systems as recommended below.

Test frequency
(MHz)
385
450 710 745 780 810 870 930

Band (MHz) 380-390 430-470 704-787
800-960

Service

Modulation

TETRA 4 00
GMRS 460 FRS 460

Pulse modulation
18Hz FM ± kHz deviation 1 kHz sine

Maximum power (W)
1.8
2

LTE Band

Pulse modulation

0.2

13, 17

217Hz

GSM 8 00/900,

TETRA 800,

Pulse

iDEN 8 20,

modulation

2

CDMA 850, LTE B and 5

18Hz

Distance (m) 0.3 0.3 0.3
0.3

Immunity test level
(V/m) 27 28
9
28

1720

GSM 1800;

CDMA 1 900;

Pulse

1845

1700-1990

GSM 1900; DECT;
LTE Band 1, 3,

modulation 217Hz

2

0.3

28

4, 25; UMTS

1970

2450

2400-2570

Bluetooth,WLAN, 802.11 b/g/n,RFID

Pulse m odulation

2

0.3

28

2450,LTE Band 7

217Hz

5240

WLAN

Pulse

5500

5100-5800

802.11

modulation

0.2

0.3

9

a/n

217Hz

5785

Electromagnetic Compatibility Information

Table 4

Recommended separation distances between portable and mobile RF communications equipment and the device
The device is intended for use in an electromagnetic environment in which radiated therefore disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

Separation distance according to frequency of transmitter

m

80 MHz to 800 MHz

800 MHz to 2.7 GHz

W

0.01

0.12

0.23

0.1

0.38

0.73

1

1.2

2.3

10

3.8

7.3

100

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE1 At 80 MHz and 800 MHz, the separation distance for the frequency range applies.

higher

NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

53 Additional Notes

54

Important Instructions Before Use

1. WARNING: Use of this equipment adjacent to or stacked with other equipment should be

avoided because it could result in improper operation. If such use is necessary, this

equipment and the other equipment should be observed to verify that they are operating

normally.

2.WARNING: PORTABLE RF communications equipment (including peripherals such as

antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any

part of Wrist-type Fully Automatic Digital Blood Pressure Monitor, including cables specified

by the MANUFACTURER. Otherwise, degradation of the performance of this equipment

could result.

3.The software identifier refer to the software evaluation report , and the file code is

JYRJ201012001.

4.verify manometer pressure accuracy:

In the power down state, press and hold the ”

” button, and theninstall

the batteries. Until the LCD screen is full, release the ”

” button.

When the LCD screen displays the double zero, the bloodpressure meter is in static state.

At this point, 500ml gas capacity, calibrated standard pressure gauge and manual pressure

device can be connected to the sphygmomanometer through the sleeve interface of the

sphygmomanometer, and manual pressure can be applied to the effective display range of the

sphygmomanometer, and then the difference between the reading of the sphygmomanometer

and that of the standard pressure gauge can be compared.This mode can be used to verify

manometer pressure accuracy.

5.Contraindications:

Product is not intended for infants or individuals who cannot express their intentions.

6.Intended Use

The digital blood pressure monitor are reusable for clinical and home use and are

non-invasive blood pressure measurement systems designed to measure the systolic and

diastolic blood pressure and pulse rate of adolescents and adults individual by using a

non-invasive technique, which is a well-known technique in the market called the

“oscillometric method”. it can measure the systolic blood pressure, diastolic blood pressure

and pulse rated on up-arm,and the device is reusable for clinical or home use.

Additional Notes

55

7.The patient is the operator: the PATIENT is an intended OPERATOR. the PATIENT Do not carry out other maintenance operations except to replace the battery. 8.WARNING: Do not modify this equipment without authorization of the manufacturer. 9. ESSENTIAL PERFORMANCE Maintenance advice: Pressure calibration will be carried out when this product leaves the factory. Patients can use the method described in the section “Verify Manometer Pressure Accuracy” to verify the accuracy. If the accuracy deviation is large, please contact the manufacturer to recalibration. 10.Mechanical strength and resistance to heatThe resistance to heat will be retained by device during the EXPECTED SERVICE LIFE of the ME EQUIPMENT. 11.Do not place the blood pressure monitor and cuff at will. It will cause asphyxiation if the child swallows or twine around his neck. 12.The cuff and the case of the blood pressure monitor have been tested for biocompatibility and do not contain allergenic or harmful materials.Please stop using it if allergy occurs during use. 13.Warning: Non- professionals do not modify the equipment, otherwise it will make the equipment measurement is not accurate. 14.Warning: Do not expose the equipment for a long time, otherwise it will reduce the performance of the equipment. 15.Warning: This device is not used for children and pets 16.Clean: The equipment can be cleaned by lay operator according to the cleaning procedures in the instructions 17.Warning: Do not use a damaged cuff for blood pressure measurement. 18.Warning: When measuring with the cuff, if the tester feels seriously uncomfortable, press the button of the blood pressure monitor to deflate the cuff, or remove the cuff directly from the arm.

Additional Notes

56

19.Warning: If an unexpected reading occurs, the operator can take several more measurements and consult a doctor. 20.Warning: This equipment is used outside the specified environment, may damage the equipment, and may be inaccurate measurement.

Correct Disposal of This Product (Waste Electrical & Electronic Equipment) This marking shown on the product indicates that it should not be disposed with other household waste at the end of its life. To prevent potential harm to the environment or to human health, please separate this product from other types of wastes and recycle it responsibly. When disposing this type of product, contact the retailer where product was purchased or contact your local government office for details regarding how this item can be disposed in an environmentally safe recycling center. Business users should contact their supplier and check the terms and conditions of the purchasing agreement. This product should not be mixed with other commercial wastes for disposal. This product is free of hazardous materials.

References

• Home in vitro diagnostic products, blood glucose meter, Lipid Panel Meter

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