SEJOY DBP-82A5B Wrist Type Fully Automatic Blood Pressure Monitor Owner’s Manual
- June 9, 2024
- Sejoy
Table of Contents
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
apBdrleoosloseduscrPee(rnestssyssuotroveleircm1oa2nndiytoedraisrassatrooefliican)gteean.nddedputolsemreaatseuroef
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.