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Antenna Specifications | Test Report | 413.24 KiB | February 21 2023 | |||
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1 | User Manual 1 | Users Manual | 691.39 KiB | February 21 2023 |
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 2 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 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 Blood Pressure monitors are intended to measure blood pressure(systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age. 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. Do not crush the pressure cuff. 5. If the unit has been stored at temperatures below 0 , leave it in a warm place for about 15 minutes before using it. Otherwise, the cuff may not inflate properly. 6. If the unit has been stored at 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 3 Safety Notice 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. 4 Safety Notice 10.DO NOT attach the cuff to a limb being used for IV infusions or any other intravascular access, therapy or an arterio-venous (A-
V) 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. 6 8 Safety Notice 5 Safety Notice 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. 28. 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 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. IP 22 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 IP 22 MR Safety Notice 7 Safety Notice 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 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. Unit Illustration Monitor Unit 9 Unit Illustration Display Charge Indication 10 Systolic Blood Pressure memory switch
" Button LCD
"SET" Button Group Time/Date
"ON/OFF" Button WHO Blood Pressure Classification Indicator Wrist Cuff
"MEM" Button Arm Shake Indicator Irregular Heartbeat Indicator Last 3 Tests Average Bluetooth Indicator MAM Indicator Battery cover 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 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 1.Monitor Unit 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 13 Quick Start 14 1. Install batteries. (See Figure A )
(See Figure D) 4. Sit in a comfortable position and place wrist level with heart. 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)
( 0 . 4 - 0 . 8 1 - 2 c m 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 System Settings With power off, press and hold 16
" 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. 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. 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. Continue setting the day, hour and minute in the same way. Every time the is pressed, it will lock in your seletion and continue in succession
( month, day,hour, minute,12/24 hours,EU/US) SET"
button Unit Operation 17 Unit Operation 18 3. Voice Setting Press voice format ON or OFF by pressing the button to enter voice setting mode. Set the button. MEM"
"SET"
4. Volume Settings Press Set the voice volume by adjusting the Smaller is for lower volume. There are six volume levels. button to enter volume setting mode. button .
"SET"
MEM"
5. Settings of cuff keeping level with heart Press button to enter Function of cuff keeping level with heart SET"
Settings of cuff keeping level with heart Set the ON or OFF by pressing
. the MEM"
button . 6. Three continuous measurement settings Press button to enter Function of cuff keeping level with heart SET"
Settings of cuff keeping level with heart Set the 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 19 Unit Operation 20 Applying The Wrist Monitor Do not apply over clothing. If wearing a long sleeved shirt, Do not stand while testing. Sit in a comfortable position with back supported, feet flat on the floor with legs uncrossed. Place middle be sure to roll sleeve back to forearm. of the cuff at the level of the right atrium of the heart. Apply monitor to wrist as illustrated. Tighten cuff firmly as not to wiggle.
( 0 . 4 - 0 . 8 1 - 2 c m Unit Operation 21 Unit Operation 22 Testing 1. Power On ON/OFF"
button to turn on the unit . The Press for one second as unit performs a quick indicate when unit is ready for testing. LCD screen will appear diagnosis. A voice tone will 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 ) When the wrist strap and the heart remain level, enter the zero grasp, the LCD screen will display as follows interface:
Note: Unit will not function if residual air from previous testing is present in cuff. The LCD will flash " "
until pressure is stabilized. Unit Operation 23 Unit Operation 24 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.
(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 IHB If the monitor detects an irregular heart rhythm two or more times during the measuring process, the Irregular Heartbeat Symbol " "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 " " frequently appears with your test results. IHB 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 Whil e reviewing the readings, the MAM averag e icon may app ear on the screen. Pres s the Set button to revi ew individual readings that make up the MAM av erage. 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 Memory Deletion Memory for a selected group may be deleted while in Memory button and on/off button 3 second Check mode. Press and hold the for approximately 3 seconds to delete all memory records from the selected MEM"
group with voice broadcast " Memory Clear " . And then transfer into testing mode. Press the " ON/OFF" button to turn the unit off. 29 Unit Operation 30 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. throughout this process. No memory loss will occur Note: Memory cannot be recovered once it has been deleted. Unit Operation Static Pressure Measurement In the power down state, press and hold the 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.
" ON/OFF "
button 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. Unit Operation Troubleshooting Abnormal phenomenon Cause analysis Processing method The armband is tied too tight or too loose, Or the arm strap is tied incorrectly;
Roll the armband correctly Abnormal sphygmomanometer Move the arm during measurement orElectronic sphygmomanometer Stay quiet, keep your arm steady, and do not move the monitor Speaking, nervous or emotional during measurement 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 Error display The cause of the problem The solution Er1 Er2 Er3 Er4 Er5 Er6 Er0 Can't detect high and low pressure Please fasten the cuff before measuring Cuff too loose or loose Please fasten the cuff before measuring Improper compression caused by arm or body movement Hold the arm or body still and measure again The pressure exceeds 300mmHg Please fasten the cuff before measuring The pressure exceeds 15mmHg for 3 minutes Check whether the cuff is knotted or the vent valve is blocked. If the problem persists, contact the manufacturer Blood pressure measurements were out of range Please tighten and measure and measure again .If you cannot solve the problem,please contact the meanufacturer Four sets of results were measured that did not meet MAM requirementsr Please tighten and measure and measure again .If you cannot solve the problem,please contact the meanufacturer Battery dead Replace the battery or connect the power adapter (if any). 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. 31 Unit Operation 32
-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. 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. 33 Blood Pressure Information 34 Blood Pressure Blood pressure is the force of blood pushing against the walls of arteries. It is typically measured in millimeters of mercury
(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 pressure to rise, while drinking alcohol and bathing can lower blood pressure. Certain hormones like adrenaline (which your body releases under stress) can cause blood vessels to constrict, leading to a rise in blood pressure. If these measuring numbers become too high, it means the heart is working harder than it should. Upper curve : systolic blood pressure Lower curve: diastolic blood pressure g H m m 200 150 100 50 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. 6 1 2 1 8 2 4 Example: fluctuation within a day (male, 35 years old) Time of day Blood Pressure Information 35 Blood Pressure Information 36 WHO Blood Pressure Classification Indicator Health Reminder The DBP-8297B is equipped with a classification indicator based Hypertension is a dangerous disease that can affect the quality 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) 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
Blood Pressure Classification Indicator 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 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. 41 Maintenance 42 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 Specifications 44 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. Function Product Description Wrist-type Fully Automatic Blood Pressure Monitor Model Display DBP-82A5B LCD Digital Display Size:47mm x 38mm Measurement Method Oscillometric Method Measurement Range Systolic Pressure 60mmHg260mmHg Diastolic Pressure 40mmHg200mmHg Pressure Pressure 0mmHg299mmHg 3mmHg Pulse 30 ~ 180 Beats/Minute Pulse 5%
Pressurization Automatic Pressurization Memory 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 Function Backlight Bluetooth 45 Specifications Continued 46 Modulation Type GFSK Version 5.0.1 BT Signal mode Power Source 2 Alkaline Batteries Size AAA Bluetooth Operation frequency 2.4GHz(2400~2483.5MHz) Battery Life Unit Weight Unit Dimensions Approximately 2 months at 3 tests per day Approx. 113g ( Excluding Battery) Approx. 86mm64mm30mm(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 Temperature
-25
(-13 ~131
~55
) Storage Environment Humidity 93% RH Transport Environment Temperature
-25~55 (-13~131) Humidity 93% RH Ingress Protection Rating IP 22 Classification Internal Powered Equipment Type BF Antenna gain 0 dBi 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 Warranty 48 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. 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 49 Electromagnetic Compatibility Information 50 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. Conducted emission CISPR 11 N/A Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 N/A N/A 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 environm-
ent. IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment
-guidance 8 kV contact 2 kV,4 kV, 8 kV, 15 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. N/A N/A N/A Electrostatic discharge (ESD) IEC 61000-4-2 Electrostatic transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interrupti-
ons and voltage variations on p-
ower supply in-
put lines IEC 61000-4-11 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
< 5% UT
(>95% dip in UT) for 0.5 cycle 40% UT
(60% dip in UT) for 5 cycle 70% UT
(30% dip in UT) for 25 cycle
<5% UT
(>95% dip in UT) for 5 secretary Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 30 A/m; 50Hz or 60Hz 30 A/m; 50Hz or 60Hz Power frequency magnetic fields should be at levels charactertic of a typical location in a typical comme-
rcial or hospital environment. Electromagnetic Compatibility Information 51 Electromagnetic Compatibility Information 52 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 environm-
ent. 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 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 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:
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:
Table 3 Guidance and declaration of m anufacturer-electromagnetic immunity Nowadays, m any R F wireless equipments have being used in various healthcare they are locations where medical equipment and/or systems used in close proximity the medical equipment and/or systems basic safety and essential performance may be affected. Arm-type Fully Automatic Digital Blood Pressure Monitor has been test level in the below table and meet the related tested with the immunity requirements of IEC 60601-1-2:2014. The help keep a minimum distance between RF wireless communications equipment and this m edical equipment and/or systems as recommended below. to medical equipment and/or systems, customer and/or user should are used. When Service Modulation Maximum power
(W) Distance
(m) Immunity test level
(V/m) TETRA 4 00 0.3 27 Test frequency
(MHz) Band
(MHz) 385 380-390 Pulse modulation 18Hz FM kHz deviation 1 kHz sine 450 430-470 GMRS 460 FRS 460 710 745 780 810 870 930 1720 1845 1970 704-787 LTE Band 13, 17 Pulse modulation 217Hz 800-960 GSM 8 00/900, TETRA 800, iDEN 8 20, CDMA 850, LTE B and 5 Pulse modulation 18Hz 1700-1990 GSM 1800;
CDMA 1 900;
GSM 1900;
DECT;
LTE Band 1, 3, 4, 25; UMTS Pulse modulation 217Hz 1.8 2 0.2 0.3 0.3 2 0.3 28 9 28 2 0.3 28 2450 2400-2570 Bluetooth,WLAN, 802.11 b/g/n,RFID 2450,LTE Band 7 Pulse m odulation 217Hz 2 0.3 28 5240 5500 5100-5800 5785 WLAN 802.11 a/n Pulse modulation 217Hz 0.2 0.3 9 Electromagnetic Compatibility Information 53 Additional Notes 54 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 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 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. 55 Additional Notes 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. 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 "
the batteries. Until the LCD screen is full, release the "
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.
" button, and theninstall
" button. 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.
1 | User Manual 2 | Users Manual | 692.14 KiB | February 21 2023 |
Owner's Manual Wrist-type Fully Automatic Blood Pressure Monitor Model DBP-82A6B Wrist Type Document No.:JDBP-A604-053 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 2 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 Thank you for purchasing the DBP-82A6B 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 Blood Pressure monitors are intended to measure blood pressure(systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age. 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. Do not crush the pressure cuff. 5. If the unit has been stored at temperatures below 0 , leave it in a warm place for about 15 minutes before using it. Otherwise, the cuff may not inflate properly. 6. If the unit has been stored at 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 3 Safety Notice 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. 4 Safety Notice 10.DO NOT attach the cuff to a limb being used for IV infusions or any other intravascular access, therapy or an arterio-venous (A-
V) 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. 6 8 Safety Notice 5 Safety Notice 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. 28. 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 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. IP 22 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 IP 22 MR Safety Notice 7 Safety Notice 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 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. Unit Illustration Monitor Unit 9 Unit Illustration Display Charge Indication 10 Systolic Blood Pressure LCD
"SET" Button Group Time/Date
"ON/OFF" Button WHO Blood Pressure Classification Indicator Wrist Cuff
"MEM" Button Arm Shake Indicator Irregular Heartbeat Indicator Last 3 Tests Average Bluetooth Indicator MAM Indicator Battery cover Pulse Rate Heart Rate Indicator Diastolic Blood Pressure Unit Illustration Contents Owner's Manual Wrist-type Fully Automatic Blood Pressure Monitor Model DBP-82A6B Wrist Type 2.Owner's Manual 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 1.Monitor Unit 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 13 Quick Start 14 1. Install batteries. (See Figure A )
(See Figure D) 4. Sit in a comfortable position and place wrist level with heart. 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)
( 0 . 4 - 0 . 8 1 - 2 c m 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 System Settings With power off, press and hold SET"
button to actuate system setting .The 16 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. 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. 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. Continue setting the day, hour and minute in the same way. Every time the is pressed, it will lock in your seletion and continue in succession
( month, day,hour, minute,12/24 hours,EU/US) SET"
button Unit Operation 17 Unit Operation 18 3. Voice Setting Press voice format ON or OFF by pressing the button to enter voice setting mode. Set the button. MEM"
"SET"
4. Volume Settings Press Set the voice volume by adjusting the Smaller is for lower volume. There are six volume levels. button to enter volume setting mode. button .
"SET"
MEM"
5. Settings of cuff keeping level with heart Press button to enter Function of cuff keeping level with heart SET"
Settings of cuff keeping level with heart Set the ON or OFF by pressing
. the MEM"
button . 6. Three continuous measurement settings Press button to enter Function of cuff keeping level with heart SET"
Settings of cuff keeping level with heart Set the 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 19 Unit Operation 20 Applying The Wrist Monitor Do not apply over clothing. If wearing a long sleeved shirt, Do not stand while testing. Sit in a comfortable position with back supported, feet flat on the floor with legs uncrossed. Place middle be sure to roll sleeve back to forearm. of the cuff at the level of the right atrium of the heart. Apply monitor to wrist as illustrated. Tighten cuff firmly as not to wiggle.
( 0 . 4 - 0 . 8 1 - 2 c m Unit Operation 21 Unit Operation 22 Testing 1. Power On ON/OFF"
button to turn on the unit . The Press for one second as unit performs a quick indicate when unit is ready for testing. LCD screen will appear diagnosis. A voice tone will 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 ) When the wrist strap and the heart remain level, enter the zero grasp, the LCD screen will display as follows interface:
Note: Unit will not function if residual air from previous testing is present in cuff. The LCD will flash " "
until pressure is stabilized. Unit Operation 23 Unit Operation 24 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.
(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 IHB If the monitor detects an irregular heart rhythm two or more times during the measuring process, the Irregular Heartbeat Symbol " "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 " " frequently appears with your test results. IHB 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 Whil e reviewing the readings, the MAM averag e icon may app ear on the screen. Pres s the Set button to revi ew individual readings that make up the MAM av erage. 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 Memory Deletion Memory for a selected group may be deleted while in Memory button and on/off button 3 second Check mode. Press and hold the for approximately 3 seconds to delete all memory records from the selected MEM"
group with voice broadcast " Memory Clear " . And then transfer into testing mode. Press the " ON/OFF" button to turn the unit off. 29 Unit Operation 30 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. throughout this process. No memory loss will occur Note: Memory cannot be recovered once it has been deleted. Unit Operation Static Pressure Measurement In the power down state, press and hold the 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.
" ON/OFF "
button 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. Unit Operation Troubleshooting Abnormal phenomenon Cause analysis Processing method The armband is tied too tight or too loose, Or the arm strap is tied incorrectly;
Roll the armband correctly Abnormal sphygmomanometer Move the arm during measurement orElectronic sphygmomanometer Stay quiet, keep your arm steady, and do not move the monitor Speaking, nervous or emotional during measurement 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 Error display The cause of the problem The solution Er1 Er2 Er3 Er4 Er5 Er6 Er0 Can't detect high and low pressure Please fasten the cuff before measuring Cuff too loose or loose Please fasten the cuff before measuring Improper compression caused by arm or body movement Hold the arm or body still and measure again The pressure exceeds 300mmHg Please fasten the cuff before measuring The pressure exceeds 15mmHg for 3 minutes Check whether the cuff is knotted or the vent valve is blocked. If the problem persists, contact the manufacturer Blood pressure measurements were out of range Please tighten and measure and measure again .If you cannot solve the problem,please contact the meanufacturer Four sets of results were measured that did not meet MAM requirementsr Please tighten and measure and measure again .If you cannot solve the problem,please contact the meanufacturer Battery dead Replace the battery or connect the power adapter (if any). 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. 31 Unit Operation 32
-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. 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. 33 Blood Pressure Information 34 Blood Pressure Blood pressure is the force of blood pushing against the walls of arteries. It is typically measured in millimeters of mercury
(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 pressure to rise, while drinking alcohol and bathing can lower blood pressure. Certain hormones like adrenaline (which your body releases under stress) can cause blood vessels to constrict, leading to a rise in blood pressure. If these measuring numbers become too high, it means the heart is working harder than it should. Upper curve : systolic blood pressure Lower curve: diastolic blood pressure g H m m 200 150 100 50 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. 6 1 2 1 8 2 4 Example: fluctuation within a day (male, 35 years old) Time of day Blood Pressure Information 35 Blood Pressure Information 36 WHO Blood Pressure Classification Indicator Health Reminder The DBP-82A6B is equipped with a classification indicator based Hypertension is a dangerous disease that can affect the quality 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-82A6B) 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
Blood Pressure Classification Indicator 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 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. 41 Maintenance 42 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 Specifications 44 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. Function Product Description Model Display Wrist-type Fully Automatic Blood Pressure Monitor DBP-82A6B LCD Digital Display Size:47mm x 38mm Measurement Method Oscillometric Method Measurement Range Systolic Pressure 60mmHg260mmHg Diastolic Pressure 40mmHg200mmHg Pressure Pressure 0mmHg299mmHg 3mmHg Pulse 30 ~ 180 Beats/Minute Pulse 5%
Pressurization Automatic Pressurization Memory 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 Function Backlight Bluetooth 45 Specifications Continued 46 Modulation Type GFSK Version 5.0.1 BT Signal mode Power Source 2 Alkaline Batteries Size AAA Bluetooth Operation frequency 2.4GHz(2400~2483.5MHz) Battery Life Unit Weight Unit Dimensions Approximately 2 months at 3 tests per day Approx. 113g ( Excluding Battery) Approx. 86mm64mm30mm(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 Temperature
-25
~55
(-13
~131
) Storage Environment Humidity 93% RH Transport Environment Temperature
-25~55 (-13~131) Humidity 93% RH Ingress Protection Rating IP 22 Classification Internal Powered Equipment Type BF Antenna gain 0 dBi 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 Warranty 48 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. 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 49 Electromagnetic Compatibility Information 50 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. Conducted emission CISPR 11 N/A Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 N/A N/A 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 environm-
ent. IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment
-guidance 8 kV contact 2 kV,4 kV, 8 kV, 15 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. N/A N/A N/A Electrostatic discharge (ESD) IEC 61000-4-2 Electrostatic transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interrupti-
ons and voltage variations on p-
ower supply in-
put lines IEC 61000-4-11 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
< 5% UT
(>95% dip in UT) for 0.5 cycle 40% UT
(60% dip in UT) for 5 cycle 70% UT
(30% dip in UT) for 25 cycle
<5% UT
(>95% dip in UT) for 5 secretary Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 30 A/m; 50Hz or 60Hz 30 A/m; 50Hz or 60Hz Power frequency magnetic fields should be at levels charactertic of a typical location in a typical comme-
rcial or hospital environment. Electromagnetic Compatibility Information 51 Electromagnetic Compatibility Information 52 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 environm-
ent. 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 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 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:
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:
Table 3 Guidance and declaration of m anufacturer-electromagnetic immunity Nowadays, m any R F wireless equipments have being used in various healthcare they are locations where medical equipment and/or systems used in close proximity the medical equipment and/or systems basic safety and essential performance may be affected. Arm-type Fully Automatic Digital Blood Pressure Monitor has been test level in the below table and meet the related tested with the immunity requirements of IEC 60601-1-2:2014. The help keep a minimum distance between RF wireless communications equipment and this m edical equipment and/or systems as recommended below. to medical equipment and/or systems, customer and/or user should are used. When Service Modulation Maximum power
(W) Distance
(m) Immunity test level
(V/m) TETRA 4 00 0.3 27 Test frequency
(MHz) Band
(MHz) 385 380-390 Pulse modulation 18Hz FM kHz deviation 1 kHz sine 450 430-470 GMRS 460 FRS 460 710 745 780 810 870 930 1720 1845 1970 704-787 LTE Band 13, 17 Pulse modulation 217Hz 800-960 GSM 8 00/900, TETRA 800, iDEN 8 20, CDMA 850, LTE B and 5 Pulse modulation 18Hz 1700-1990 GSM 1800;
CDMA 1 900;
GSM 1900;
DECT;
LTE Band 1, 3, 4, 25; UMTS Pulse modulation 217Hz 1.8 2 0.2 0.3 0.3 2 0.3 28 9 28 2 0.3 28 2450 2400-2570 Bluetooth,WLAN, 802.11 b/g/n,RFID 2450,LTE Band 7 Pulse m odulation 217Hz 2 0.3 28 5240 5500 5100-5800 5785 WLAN 802.11 a/n Pulse modulation 217Hz 0.2 0.3 9 Electromagnetic Compatibility Information 53 Additional Notes 54 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 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 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. 55 Additional Notes 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. 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 "
the batteries. Until the LCD screen is full, release the "
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.
" button, and theninstall
" button. 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.
1 | Label & Label Location | ID Label/Location Info | 61.29 KiB | February 21 2023 |
Size: 39*13mm Wrist-Type Fully Automatic Digital Blood Pressure Monitor Model: DBP-82A5B Manufacturers by JOYTECH Healthcare Co., Ltd. No. 365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City, 311100 Zhejiang, China Power: 2X1.5V Batteries AAA Size Series number:
Manufacturing Date:
IP22 FCC ID:2AQVU0037 Made in china MR Size: 39*13mm Wrist-Type Fully Automatic Digital Blood Pressure Monitor Model: DBP-82A6B Manufacturers by JOYTECH Healthcare Co., Ltd. No. 365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City, 311100 Zhejiang, China Power: 2X1.5V Batteries AAA Size Series number:
Manufacturing Date:
IP22 FCC ID:2AQVU0037 Made in china MR
1 | Attestation Statements Part 2.911(d)(5) | Attestation Statements | 268.54 KiB | February 21 2023 |
JOYTECH Healthcare Co.,Ltd. Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: February 14, 2023 Ref: Attestation Statements Part 2.911(d)(5)(i) Filing FCC ID: 2AQVU0037 JOYTECH Healthcare Co.,Ltd. (the applicant) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Sincerely, Signature: bon 1S ur printed name: Lan Yingting Rev 2/13/2023 JOYTECH Healthcare Co.,Ltd. Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: February 14, 2023 Ref: Attestation Statements Part 2.911(d)(5)(ii) Filing FCC ID: 2AQVU0037 JOYTECH Healthcare Co.,Ltd. (the applicant) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing covered equipment. Sincerely, Signature: Low larg printed name: Lan Yingting Rev 2/13/2023
1 | Confidentiality Letter | Cover Letter(s) | 224.95 KiB | February 21 2023 |
JOYTECH HEALTHCARE CO., LTD. Federal Communications Commission Authorization and Evaluation Division Confidentiality Request regarding application for certification of FCC ID: 2AQVU0037 Pursuant to Sections 0.457 and 0.459 of the Commissions Rules, we hereby request confidential treatment of information accompanying this application as outlined below:
Exhibit Type File Name
(Block Diagram, Schematics, Operational (Block Diagram.pdf, Schematics.pdf, Description): Operational Description.pdf) The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. :
Pursuant to DA04-1705 June 15, 2004 of the Commissions public notice, we also request temporary confidential treatment of information accompanying this application as outlined below:
Exhibit Type File Name Sincerely, Signature: | am ry printed name: Lan Yingting Rev 11/20/07
1 | Models Declaration Letter | Cover Letter(s) | 154.10 KiB | February 21 2023 |
JOYTECH HEALTHCARE CO., LTD. Model Confirmation Letter We, JOYTECH HEALTHCARE CO., LTD certify the product: Wrist-type Fully Automatic Digital Blood Pressure Monitor. And models: DBP-82A5B, DBP-82A6B, the main test model: DBP-82A5B. Their circuit design, layout, components used and internal wiring are the same. The model DBP-82A5B have an Individual Memory group switching button of the product, while the coverage model DBP-82A6B reached the Memory group switching function through by SETTING button . Signature: Low yy Printed name: Lan Yingting Company Name: JOYTECH HEALTHCARE CO., LTD. Date: 2023/1/7
1 | Power of Attorney Letter | Cover Letter(s) | 257.42 KiB | February 21 2023 |
JOYTECH HEALTHCARE CO., LTD. Federal Communications Commission Authorization and Evaluation Division 1435 Oakland Mills Road Columbia, MD 21046 Date: January 7, 2023 SUBJECT: FCC Application for (FCC ID: 2AQVU0037) To Whom It May Concern:
We, the undersigned, hereby authorize Mina Xu at Centre Testing International Group Co. Ltd / Building C, Hongwei Industrial Park Block 70, Bao'an District, Shenzhen, China on our behalf, to apply to the Federal Communications Commission on our equipment. Any and all acts carried out by Mina Xu at Centre Testing International Group Co., Ltd /
Building C, Hongwei Industrial Park Block 70, Bao'an District, Shenzhen, China on our behalf shall have the same effect as acts of our own. This is to advise that we are in full compliance with the Anti- Drug Abuse Act. We, the applicant, are not subject to a denial of federal benefits pursuant to Section 5301 of the Anti-Drug Act of 1988, 21 USC853a, and no party to the application is subject to a denial of federal benefits pursuant to that section. Regards, Signature: Lom Teey printed name: Lan Yingting C:\Users\Administrator\Desktop\7. EED320818977 DBP-82A5B FCC 225 X{#\POA Letter.docx
1 | US Agent Letter | Attestation Statements | 297.34 KiB | February 21 2023 |
Attestation Statements Date: February 16, 2023 TO: Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046, USA RE: Attestation Statements Part 2.911(d)(7) request for FCC ID: 2AQVU0037 JOYTECH Healthcare Co.,Ltd. the undersigned, hereby authorize CTI U.S. Inc. to act as our designated U.S. agent for service of process, JOYTECH Healthcare Co.,Ltd. accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. CTIU.S. Inc. accepts the responsibility to act as designated U.S. agent for service of process, provides an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. Applicant Information:
Company name: JOYTECH Healthcare Co.,Ltd. Contact Name: Lan Yingting Address: No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City, Zhejiang, 311100, China Telephone No: 0571-81957767 Email: cel@sejoy.com U. S. Agent Information:
FRN: 0033406968 Name: CTI U.S. Inc. Address: Suite 230, 1455 CTI U.S. Inc.Lincoln Parkway, Atlanta, GA, 30346 Contact Person: Robin Zhang Tel.: 248-461-3673 robin.zhang@cti-cert.com Applicant Signature: Daa os tiny Agent Signature:
(if the agent is different from the applicant) Applicant printed name: Lan Yingting Agent printed name: Robin Zhang
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2023-02-21 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2023-02-21
|
||||
1 | Applicant's complete, legal business name |
JOYTECH HEALTHCARE CO., LTD.
|
||||
1 | FCC Registration Number (FRN) |
0027764067
|
||||
1 | Physical Address |
No.365, Wuzhou Road, Yuhang Economic Development Zone
|
||||
1 |
No.365, Wuzhou Road
|
|||||
1 |
Hangzhou City, Zhejiang, N/A
|
|||||
1 |
China
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
T******@timcoengr.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AQVU
|
||||
1 | Equipment Product Code |
0037
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
L******** Y******
|
||||
1 | Title |
QA
|
||||
1 | Telephone Number |
0571-********
|
||||
1 | Fax Number |
0571-********
|
||||
1 |
c******@sejoy.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Wrist-type Fully Automatic Digital Blood Pressure Monitor | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power listed is conducted. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Centre Testing International Group Co., Ltd
|
||||
1 | Name |
V**** Z****
|
||||
1 | Telephone Number |
N/A********
|
||||
1 |
z******@cti-cert.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0013000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC