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DBP1257b-FDA Manual | Users Manual | 622.71 KiB | ||||
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1 | DBP1257b-FDA Manual | Users Manual | 622.71 KiB |
Document No.: JDBP-5304-050 Version: Z Date of Issue: 2018.12 Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1257b Arm Type 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
......................................................... 06 Unit Illustration
..................................... 10 Important Testing Guidelines Quick Start ................................................................. 11 Unit Operation ........................................................... 12 Battery Installation .................................................. 12 Time/Date Setting ....................................................... 13 Applying the Arm Cuff ............................................. 14 Testing ..................................................................... 15 Power Off ................................................................ 17 Memory Check .......................................................... 17 Memory Deletion ..................................................... 17 Troubleshooting ...................................................... 21
........................................ 22 Blood Pressure Information
................................................... 24 Blood Pressure QA
............................................................... 25 Maintenance
............................................................. 27 Specifications Warranty .................................................................... 29 Electromagnetic Compatibility Information .............. 30 Thank you for purchasing the DBP-1257b Blood Pressure Monitor. The unit has been constructed using reliable circuitry and durable materials. Used properly, this unit will provide yeas of satisfactory use. Measure blood pressure(systolic and diastolic)and pulse rate of adults and adolecents age 12 through 21years of age. All functions can be used safely and values can be read out in one LCD DISPLAY. Measurement position is on adult upper arm only. 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 81060-2-30) 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 oC, 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 oC, 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. Safety Notice 3 Safety Notice 4 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. 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 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 arm cuff. Do not attempt to repair. 19. Use only the approved arm cuff for this unit. Use of other arm cuffs may result in incorrect measurement results. 20. The system might produce incorrect readings if stored or used outside the manufacturer's specified temperature and humidity ranges. 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. Do not use the device during patient transport outside healthcare facility for interference source existing as well. 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. Only use a recommended AC adaptor double-insulated complying with EN 60601-1 and EN 60601-1-2. An unauthorized adapter may cause fire and electric shock. 29. Advising operator that Instruction manual/ Booklet must be consulted . 30.Do not use the device during transport vehicles for influencing measurement accuracy, such as patient transport in an ambulance or helicopter. 31. Contains small parts that may cause a chocking hazard if swallowed by infants. 32. Please align the polarities of each battery with the +ve and -ve signs imprinted on the battery housing when you replace the batteries . 33.This ME equipment or ME systems should be only used in shielded location. 34.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. 35.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 the unit, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Safety Notice 5 Safety Notice 6 WARNING SIGNS AND SYMBOLS USED Keep Dry 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. Federla Commulcation Commission (FCC) Interference Statement 1.This device complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. 2.This device is verified to comply with part 15 of the FCC Rules for use with cable television service. 3.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. 4.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. Unit Illustration Monitor Unit 7 Unit Illustration 8 Arm Cuff Medium size cuff (fits arm circumference: 22.0 cm -36.0 cm). Systolic Blood Pressure Diastolic Blood Pressure
" M " Button
" " Button
"SET" Button Air Jack Pulse Rate
"
MEM Button
"
AC Adapter Jack Battery cover 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 0 . 4 c m (
2
~
1 M R T A F E L
) h c n 0 . 8 i
~
M a i n A r t y r e I N D X E Arm Cuff Air Plug Air Tube If air is leakingfrom the arm cuff, replace the arm cuff with a new one. It is generally recommended to have the cuff replaced timely to ensure correct functioning and accuracy. Please consult your local authorized distributor or dealer. Display Low Battery Indicator WHO Blood Pressure Classification Indicator Last 3 Results Average Irregular Heartbeat Indicator Time Date Systolic Blood Pressure Diastolic Blood Pressure Pulse Rate Unit Illustration 9 Important Testing Guidelines 10 Contents Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1257b Arm Type 2.Owner's Manual 4.Storage Bag 1.Monitor Unit M R T A F E L
) h c n 0 . 8 i
~
M a i n A r t y r e I N D X E 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 0 . 4 c m (
2
~
1 3.Arm Cuff 5.2MOPPMedical AC Adapter(DC6.0 V,600mA)
(recommended, not provided) Avoid eating, exercising, and bathing for 30 minutes prior to testing. Sit in a calm environment for at least 5 minutes prior to testing. 1. 2. 3. Do not stand while testing. Sit in a relaxed position while keeping your arm level with your heart. 4. Avoid speaking or moving body parts while testing. 5. While testing, avoid strong electromagnetic interference such as microwave ovens and cell phones. 6. Wait 3 minutes or longer before re-testing. Try to measure your blood pressure at the same time each day for consistency. 7 8
. Test comparisons should only be made when monitor is used on the same arm, 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. Any blood pressure recording can be affected by the following factors:
1. The position of the subject, his or her physiologic condition;
2. The performance and accuracy of the device;
3. Cuff size: too small cuff (bladder) will produce a higher blood pressure value than usual, too big cuff (bladder) will produce a lower blood pressure value;
4. Measuring position does not keep level with your heart;
5. Speaking or moving body parts while testing;
6. Not relaxing for about 5 minutes before taking the measurement. Quick Start 1. Install batteries 2. Insert cuff air plug into the left side of monitor unit. (See Figure B)
. (See Figure A ) 11 Unit Operation Battery Installation Slide battery cover off as indicated by arrow. Install 4 new AAA alkaline batteries according to polarity. Close battery cover. 12 Figure A Figure B 3. Remove thick clothing from the arm area. 4. Rest for several minutes prior to testing. Sit down in a quiet place comfortably , back and arm support on a desk or table ,with your legs uncrossed ,your arm resting on a firm and your feet flat on the floor. (See Figure C ) Figure C AC Adapter jack is on the right side of the monitor. Medical AC adapter(DC 6.0 V,600mA) can be used with the device (recommended, not provided). The adapter connect pin should be positive inside and negative outside with a 2.1mm coaxial joint. Do not use another type of AC adaptor as it may harm the unit. 5. Apply cuff to your left arm and middle of the cuff at the level of your heart. Bottom of cuff should be placed approximately 1-2cm (1/2'') above elbow joint.(See Figures D&E) 1
-
2 c m
(
0.4
-
0.8
''
) Figure D Figure E 6. Press
" "
Button to start testing. Note:Power supply is specified as part of ME EQUIPMENT. AC Adapter Jack Unit Operation 1. Time/Date setting PressSET button again to set the Time/Date mode. Set the year first by adjusting the M button. PressSET button again to confirm curret month. Continue setting the date, hour and minute in the same method. Every time the SET button is pressed, it will lock in your seletion and continue in succession ( month,date,hour, minute) 13 Unit Operation Applying the Arm Cuff 1. Firmly insert air plug into opening located on left side of monitor unit. 14
/
2. With sticky nylon section facing outward, insert end of cuff underneath metal ring of cuff
. 3. Fasten cuff about 1-2cm (0.4-0.8'') above the elbow joint. For best results apply cuff to
" button to turn the unit off. All bare arm and keep level with heart while testing
. 2. Saved Settings While in any setting mode, press "
information will be saved. Note: If unit is left on and not in use for 3 minutes, it will automatically save all information and shut off. 1
-
2 c m
(
0.4
-
0.8
''
) Note: Do not insert air plug into opening located on right side of monitor unit. This opening is designed for an optional power supply only. Unit Operation Testing Press and hold 1. Power On appear for one second as unit performs a quick diagnosis. A long tone indicates device is ready for testing. button until a beep sounds. The LCD screen will
" "
15 Unit Operation 16 3. Testing After cuff inflation, air will slowly subside as indicated by the corresponding cuff pressure value. A flashing " " will appear simultaneously on screen signaling heart beat detection. Note: Unit will not function if residual air from previous testing is present in cuff. The LCD will flash " " until pressure is stabilized. 2. Pressurization The unit will automatically inflate to the proper shelf and stop inflating. During this time, please keep quiet. mmHg mmHg M D Note: Keep relaxed during testing. Avoid speaking or moving body parts. 4. Result Display Three short beeps sound when testing is complete. The screen will display measurements for systolic and diastolic blood pressure. mmHg M D M D Note: Refer to Page 17 for detail Blood Pressure Information. Unit Operation Power Off turn off the power itself about 3 minutes no operation in any mode. The " " button can be pressed to turn off the unit in any mode. The unit can 17 Safety Precaution: If pressure in arm cuff becomes too extreme while testing, press the " " button to turn power off. The cuff pressure will rapidly dissipate once the unit is off. Memory Check With power off, press and hold M button to turn the unit on.The LCD will display the last measurement memory as reading . Older test result in memory can be viewed by pressing theMbutton. No mmHg D No M M D Memory Deletion Which in memory check made. Press delete all history results and the LCD screen display with beep sounds. Then press
" "
and hold on for about 3 seconds to button to turn off the unit.
" "
Unit Operation Low Battery Indicator 4 short warning beeps sound when battery life is depleting and unable to inflate cuff for testing. The " " appears simultaneously for approximately 5 seconds prior to shutting off. No memory loss will occur throughout this process. Replace batteries at this time. 18 Static Pressure Measurement In the power down state, press and hold the " " button, and theninstall the batteries. Until the LCD screen is full, release the " " button. When the LCD screen displays the double zero, the bloodpressure meter is in static state. Software version is displayed at the heart rate . mmHg M D Note: Only Service personnel permitted to access to this mode, the mode unavailable in normal use. Unit Operation Bluetooth requirements The monitor requires a device with:
. Bluetooth 4.0 or later
. Android 5.0 or later
. IOS 9.0 or later And works with:
. iphone , iPod, iPad
. Android Phones and Tablets Wireless communication Frequency range : 2.4 Ghz (2400-2483.5 MHz) Modulation : GFSK Antenna gain:0.5dBi 19 Unit Operation 20 Bluetooth connection Using for the first time 1. Download the free JOYTECH healthcare 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. Pairing your monitor with a Smart Device The date and time on your monitor will automatically be set when you pair it with your smart device. 1. Make sure the Bluetooth in your smart device is turned on. 2. Open the app on your smart device and follow the set-up and pairing instructions. 3. Confirm the monitor is connected successfully. If the monitor is connected successfully to the smart device, bLE on will appear on the monitor display. mmHg
/
Unit Operation Troubleshooting 21 Blood Pressure Information 22 Problem Possible Cause Solution Blood Pressure Cuff is too tight or not properly positioned on the arm Firmly reposition cuff approximately
(
above the elbow joint
( See Page 12) 1-2cm 1/2"
) Blood pressure results are not within typical range Inaccurate test results due to body movement or monitor movement Sit in a relaxed position with arm placed near heart. Avoid speaking or moving body parts while testing. Make sure the monitor unit is placed in a stationary position throughout the testing period.
( See Page 7) Cuff fails to inflate properly Make sure hose is properly fastened to cuff and monitor unit Improper operation Read user manual carefully and re-test properly.
" "displayed Connection failure./
Data is not being transmitted Pressurization is over cuff rated pressure 300mmHg The blood pressure monitor might not be porperly placed within the smart devices tranmission range and is too far from the smart device. Read user manual carefully and re-test properly. If there are no causes of data transmission interference found near the blood pressure monitor, move the blood pressure monitor within 16ft.(5m) of the smart device and try again The blood pressure did not pair successfully to the smart device Try to pair the devices once again. The application on the smart device is not ready. Check the application then try sending the data again. 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 200 150 100 50 g H m m 6 12 18 Time of day 24 Example: fluctuation within a day (male, 35 years old) Blood Pressure Information 23 Blood Pressure QA 24 Health Reminder Hypertension is a dangerous disease that can affect the quality of life. It can lead to a lot of problems including heart failure, kidney failure, and cerebral hemorrhaging. By maintaining a healthy lifestyle and visiting your physician on a regular basis, hypertension and relative diseases are much easier to control when diagnosed in their 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. early stages. Systolic
( mmHg ) 180 160 140 130 120 Severe Hypertension Moderate Hypertension Mild Hypertension High-normal Normal Optimal 80 85 90 100 110 Diastolic
( mmHg ) Note: Do not be alarmed if an abnormal reading occurs. blood pressure occurs after 2-3 readings are taken at the same time extended period of time. Consult your physician if test results remain abnormal. A better indication of an individual's each day over an Note: Abnormal test results may be caused by:
1. Improper cuff placement Make sure cuff is snug-not too tight or too loose. Make sure bottom of the cuff is approximately 1-2cm (1/2'') above the elbow joint. 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. 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 arm? What is the difference?
A: Either arm can be used when testing, however, when comparing results, the same arm should be used. Testing on your left arm 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. Maintenance 1. Avoid dropping, slamming, or throwing the unit. 25 Maintenance 26 Cuff Cleaning:
Do not soak cuff in water!
4. 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 differentusers. Apply a small amount of rubbing alcohol to 5. Do not use petrol, thinners or similar solvents. 2. Avoid extreme temperatures. Do not expose unit directly under sunshine. 6. Remove batteries when not in operation for an extended period of time. 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. 7. Do not disassemble product. 8. It is recommended the performance should be checked every 2 years. 9. Expected service life: Approximately three years at 10 tests per day. 10.No service and maintenance while it is in use and maintenance only be performed by service personnel. Service and maintenance require parts, repair, technical support will be provided. Specifications 27 Specifications Product Description Arm-type Fully Automatic Blood Pressure Monitor Model Display DBP-1257b LCD Digital Display Size: 30mm45mm Measurement Method Oscillometric Method Systolic Pressure 60mmHg280mmHg Diastolic Pressure 30mmHg200mmHg Pressure Pressure 0mmHg300mmHg 3mmHg Measurement Range Pulse 30 ~ 180 Beats/Minute Pressurization Memory Function Power Source Battery Life Unit Weight Pulse Automatic Pressurization 5%
120 Memories Low Battery Detection Automatic Power-Off Bluetooth 4 AAA batteries or Medical AC Adapter ( DC 6.0V,600mA )
( Recommended, not provided ) Approximately 2 m onths at 3 tests per day Approx.360g (12.7 oz.) (excluding battery) Unit Dimensions Approx.131.2 x 101.8 x 44.1mm (L x W x H) Cuff Circumference Approx.135 (W)485(L) mm
(Medium cuff: Fits arm circumference 22-36 cm) Temperature 10 ~ 40 (50 ~104
) Operating Environment Humidity Pressure 15%93%RH 700hPa~1060hPa Warranty 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 Pressure Monitor due to improper handling. Please contact local retailer for details. Storage Environment Temperature:
Humidity 28
)
(-13 ~158
-25 ~70 93% RH Classification:
Ingress Protection rating:
Internal Powered Equipment,Type BF . Cuff is the Applied Part IP 20,Indoor Used Only Specifications are subject to change without notice. International Standards:
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. ANSI/AAMI ISO 81060-2, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type. (Cardiovascular) 3. AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)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. 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. 29 30 Electromagnetic Compatibility Information The device satisfies the EMC requirements of the international standard IEC 60601-1-2. The requirements are satisfied under the conditions described in the table below. The device is an electrical medical product and is subject to special precautionary measures with regard to EMC which must be published in the instructions for use. Portable and mobile HF communications equipment can affect the device. Use of the unit in conjunction with non-approved accessories can affect the device negatively and alter the electromagnetic compatibility. The device should not be used directly adjacent to or between other electrical equipment. Table 1 Guidance and declaration of manufacturer-electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. 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. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Emissions test Compliance Radiated emission CISPR 11 Group 1, class B. Conducted emission CISPR 11 Group 1, class B. Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Class A Complies Electromagnetic Compatibility Information Table 2 Guidance and declaration of manufacturer-electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environm-
ent. IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment
-guidance Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV,4 kV, 8 kV, 15 kV air 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 %. Electrostatic transient/burst IEC 61000-4-4 2 kV , 100kHz, for AC power port 2 kV , 100kHz, for AC power port Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 0.5kV, 1kV
(differential mode) 0.5kV, 1kV
(differential mode) Mains power quality should be that of a typical commercial or hospital environment. 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT;
250/300 cycle 0 % UT;
250/300 cycle Voltage dips, short interrupti-
ons and voltage variations on p-
ower supply in-
put lines IEC 61000-4-11 Mains power quality should be that of a typical commercial or hospital environment. 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. 31 Electromagnetic Compatibility Information 32 Table 3 Guidance and declaration of manufacturer-electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-
4-3 IEC 60601 test level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz Compliance level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz 385MHz, 27V
/m 385MHz, 27V
/m 450MHz, 28V
/m 450MHz, 28V
/m 710MHz,745 MHZ,780MHz 9V/m 710MHz,745 MHZ,780MHz 9V/m 810MHz,870 MHZ,930MHz 28V/m 810MHz,870 MHZ,930MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 2450MHz, 28V
/m 2450MHz, 28V
/m 5240MHz,5500 MHZ,5785MHz 9V/m 5240MHz,5500 MHZ,5785MHz 9V/m Electromagnetic environment
-guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended seperation distance 80 MHz to 800 MHz 800 MHz to 2.7 Ghz where P is the maximum output power rating of the transmitter in watts (W) according to the transm-
itter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:
Electromagnetic Compatibility Information 33 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 W 0.01 0.1 1 10 100 Separation distance according to frequency of transmitter m 800 MHz to 2.7 GHz 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 80 MHz to 800 MHz 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 th frequency range applies. e higher NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
1 | DBP1305b-FDA Manual | Users Manual | 761.43 KiB |
Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1305b Arm Type Document No.:JDBP-1304-050 VersionZ Date of Issue2018.12 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 Safety Notice ............................................................... 02
......................................................... 06 Unit Illustration
..................................... 09 Important Testing Guidelines Quick Start ................................................................. 10 Unit Operation ........................................................... 11 Battery Installation .................................................. 11 System Settings ........................................................ 12 Applying the Arm Cuff ............................................. 14 Testing ..................................................................... 17 Power Off ................................................................ 18 Memory Check ........................................................ 19 Memory Deletion ..................................................... 20 Last 3 Tests Average ................................................. 21 Low Battery Indicator ............................................. 22
.............................................. 23 Troubleshooting ...................................................... 25
........................................ 28 Blood Pressure Information
................................................... 29 Blood Pressure QA
............................................................... 30 Maintenance
............................................................. 32 Specifications Warranty .................................................................... 34 Electromagnetic Compatibility Information .............. 35 Bluetooth requirements 1 Safety Notice 2 Thank you for purchasing the DBP-1305b Blood Pressure Monitor. The unit has been constructed using reliable circuitry and durable materials. Used properly, this unit will provide years of satisfactory use. Measure blood pressure(systolic and diastolic)and pulse rate of adults and adolecents age 12 through 21years of age. All functions can be used safely and values can be read out in one LCD DISPLAY. Measurement position is on adult upper arm 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 81060-2-30) 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 oC, 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 oC, 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. Safety Notice 3 Important Instructions Before Use 1. Do not confuse self-monitoring with self-diagnosis. Blood pressure measurements should only be interpreted by a health professional who is familiar with your medical history. 2. Contact your physician if test results regularly indicate abnormal readings. 3. If you are taking medication, consult with your physician to determine the most appropriate time to measure your blood pressure. NEVER change a prescribed medication without first consulting with your physician. 4. Individuals with serious circulation problems may experience discomfort. Consult your physician prior to use. 5. For persons with irregular or unstable circulation resulting from diabetes, liver disease, arteriosclerosis or other medical conditions, there may be variations in blood pressure values measured at the wrist versus at the upper arm. Monitoring the trends in your blood pressure taken at either the arm or the wrist is nevertheless useful and important. 6. People suffering from vascular constriction, liver disorders or diabetes, people with cardiac pacemakers or a weak pulse, and women who are pregnant should consult their physician before measuring their blood pressure themselves. Different values may be obtained due to their condition. 7. People suffering from arrhythmias such as atrial or ventricular premature beats or atrial fibrillation only use this blood pressure monitor in consultation with your doctor. In certain cases oscillometric measurement method can produce incorrect readings. 8.Too frequent measurements can cause injury to the patient due to blood flow interference. 9.The cuff should not be applied over a wound as this can cause further injury. 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 arm cuff. Do not attempt to repair. 19. Use only the approved arm cuff for this unit. Use of other arm cuffs may result in incorrect measurement results. 20. The system might produce incorrect readings if stored or used outside 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. 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. Safety Notice 4 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. Dispose batteries properly; observe local laws and regulations. 27. Only use a recommended AC adaptor double-insulated complying with EN 60601-1 and EN 60601-1-2. An unauthorized adapter may cause fire and electric shock. 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. Please align the polarities of each battery with the +ve and -ve signs imprinted on the battery housing when you replace the batteries . 32.This ME equipment or ME systems should be only used in shielded location. 33.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. 34.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 the unit, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. WARNING SIGNS AND SYMBOLS USED Keep Dry 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. Safety Notice Federla Commulcation Commission (FCC) Interference Statement 5 Unit Illustration 6 1.This device complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. 2.This device is verified to comply with part 15 of the FCC Rules for use with cable television service. 3.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. 4.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. Monitor Unit Blood Pressure Classification Indicator LCD SYS m mHg Systolic Blood Pressure Diastolic Blood Pressure Pulse Rate DIA m mHg PUL
/min M START STOP SET Air Jack
" "
M Button START/STOP
"
"
Button
"
"
SET Button Battery cover AC Adapter Jack Unit Illustration Arm Cuff 7 Unit Illustration 8 Contents 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 0 . 4 c m (
2
~
1 M R T A F E L
) h c n 0 . 8 i
~
M a i n A r t y r e I N D X E Arm Cuff Air Plug Air Tube Display Groups Low Battery Indicator WHO Blood Pressure Classification Indicator mmHg kPa Last 3 Results Average Irregular Heartbeat Indicator AVG
(( )) Time Date D No M Systolic Blood Pressure Diastolic Blood Pressure Pulse Rate SYS m mHg DIA m mHg PUL
/min M START STOP SET 1.Monitor Unit Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1305b Arm Type 2.Owner's Manual M R T A F E L
) h c n 0 . 8 i
~
M a i n A r t y r e I N D X E 4.Storage Bag 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 0 . 4 c m (
2
~
1 3.Arm Cuff 5.2MOPPMedical AC Adapter(DC6.0 V,600mA)
(recommended, not provided) Important Testing Guidelines 9 Quick Start 10 Avoid eating, exercising, and bathing for 30 minutes prior to testing. Sit in a calm environment for at least 5 minutes prior to testing. 1. 2. 3. Do not stand while testing. Sit in a relaxed position while keeping your arm level with your heart. 4. Avoid speaking or moving body parts while testing. 5. While testing, avoid strong electromagnetic interference such as microwave ovens and cell phones. 6. Wait 3 minutes or longer before re-testing. Try to measure your blood pressure at the same time each day for consistency. 7 8
. Test comparisons should only be made when monitor is used on the same arm, 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. 1. Install batteries 2. Insert cuff air plug into the left side of monitor unit. (See Figure B)
. (See Figure A ) SYS m mHg DIA m mHg PUL
/min M START STOP SET Figure A Figure B 3. Remove thick clothing from the arm area. 4. Rest for several minutes prior to testing. Sit down in a quietplace comfortably , back and arm support on a desk or table ,withyour legs uncrossed ,your arm resting on a firm and your feet flat on the floor. (See Figure C ) Figure C 5. Apply cuff to your left arm and middle of the cuff at the level of your heart. Bottom of cuff should be placed approximately 1-2cm (1/2'') above elbow joint. (See Figures D&E) 1
-
2 c m
(
0.4
-
0.8
''
) Figure D Figure E 6. Press
" START/STOP "
Button to start testing. Unit Operation Battery Installation Slide battery cover off as indicated by arrow. Install 4 new AA alkaline batteries according to polarity. Close battery cover. 11 Unit Operation System Settings 12 With power off, press "SET" button to activate System Settings. The Memory Group icon flashes. 1. Select Memory Group While in the System Setting mode, you may accumulate test results into 2 different groups. This allows multiple users to save individual test results (up to 60 memories per group.) Press " M " button to choose a group setting. Test results will automatically store in each selected group. AC Adapter jack is on the right side of the monitor. Medical AC adapter(DC 6.0 V,600mA) can be used with the device (recommended, not provided). The adapter connect pin should be positive inside and negative outside with a 2.1mm coaxial joint. Do not use another type of AC adapter as it may harm the unit. 2. Time /Date Setting Press "SET" button again to set the Time/Date mode. Set the month first by adjusting the
" M " button. Press "SET " button again to confirm current month. Continue setting the day, hour and minute in the same way. Every time the " SET " button is pressed, it will lock in your selection and continue in succession (month, day, hour, minute.) AC Adapter Jack Note:Power supply is specified as part of ME EQUIPMENT. M D Unit Operation 13 Unit Operation 14 3.Voice Setting Press "SET" button to enter voice setting mode. Set the voice format ON or OFF by pressing the "M" button. Applying the Arm Cuff 1. Firmly insert air plug into opening located on left side of monitor unit. SYS m mHg DIA m mHg PUL
/min M START STOP SET 4.volum setting Press "SET" button to enter volume setting mode. Set the voice volume by adjusting the "M"
button. There are six volume levels. 2. With sticky nylon section facing outward, insert end of cuff underneath metal ring
. of cuff 3. Fasten cuff about 1-2cm (0.4-0.8'') above the elbow joint. For best results apply cuff to bare arm and keep level with heart while testing
. 1
-
2 c m
(
0.4
-
0.8
''
) 5. Saved Settings While in any setting mode, press " START/STOP " button to turn the unit off. All information will be saved. Note: Do not insert air plug into opening located on right side of monitor unit. This opening is designed for an optional power supply only. Note: If unit is left on and not in use for 3 minutes, it will automatically save all information and shut off. Unit Operation Testing 15 Unit Operation 16 2. Pressurization The unit will automatically inflate to the proper pressure value and stop inflating. During this time,please keep quiet. The LCD screen will appear for one Press "START/STOP" button to turn the unit on. 1. Power On second as unit performs a quick diagnosis. is ready for testing A voice tone will indicate when unit mmHg kPa AVG
(( )) D No M Note: Unit will not function if residual air from previous testing is present in cuff. The LCD will flash " " until pressure is stabilized. mmHg M D Note: Pressurization will gradually subside and ultimately stop when cuff is not properly applied to the arm. If this occurs, press START/STOP button to turn the unit off. Unit Operation 17 Unit Operation 18 3. Testing After cuff inflation, air will slowly subside as indicated by the corresponding cuff pressure value. A flashing " " will appear simultaneously on screen signaling heart beat detection. mmHg M D Note: Keep relaxed during testing. Avoid speaking or moving body parts. 4. Result Display corresponding WHO Classification. The screen will display measurements for systolicand diastolic blood pressure with voice broadcast. A indicator representing the current measurement will appear next to the Indicator mmHg M D Note: Refer to Page 23~24 for detail WHO Blood Pressure Classification Information. Irregular Heartbeat Indicator If the monitor detects an irregular heart rhythm two or more times during the measuring process, the Irregular Heartbeat Symbol " "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. 5. Deleting/Storing Test Results User may delete their current test result due to unfavorable testing conditions or for any other reason. To delete the last test result, press the "SET" button after result is displayed. If result is not deleted, it will automatically store by date within the previously configured Memory Group. Note: Be sure the appropriate Memory Group selection is made prior to testing. If the number of tests surpasses the allotted 60 memories per group, the most recent tests will appear first, thus eliminating the oldest readings. Power Off turn off the power itself about 3 minutes no operation in any mode. The " START/STOP " button can be pressed to turn off the unit in any mode. The unit can Safety Precaution: If pressure in arm cuff becomes too extreme while testing, press the " START/STOP " button to turn power off. The cuff pressure will rapidly dissipate once the unit is off. Unit Operation Memory Deletion Memory for a selected group may be deleted while in Memory Check mode. Press and hold the " SET " button for approximately 3 seconds to delete all memory records from the with voice broadcast "Memory Clear"
selected group Press the " START/STOP " button to turn the unit off. and then transfer into testing mode. 20 Unit Operation Memory Check With power off, you may check past test results by using the " M " button. The most recent test result and oldest test result in memory can be viewed by pressing and holding the " M " button upon activating test results you can press the M button to scroll through all test results stored in memory. 19 mmHg D No M M D Note: Previous test results will only be displayed from the most recently used memory group. To check previous test results in other memory groups, you must first select the desired group and then turn monitor off.
(See Select Memory Group on Page 10.)
"
"
Note: Memory cannot be recovered once it has been deleted. Unit Operation 21 Unit Operation 22 Last 3 Tests Average With power off, press the " M " 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 with voice broadcast
. The " " symbol will appear along with the corresponding WHO Blood Pressure Indicator. The Memory Check mode can be accessed by pressing the "M " button. To check the average results from other groups, select Low Battery Indicator The unit will broadcast"Low Battery"
testing. The " " appears simultaneously for approximately 5 seconds prior to shutting off. No memory loss will occur throughout this process. when battery life is depleting and unable to inflate cuff for Replace batteries at this time. the desired group first prior to activating the " M " button in the off position.
(See Select
"
Memory Group on Page 10.)
"
mmHg AVG M D Static Pressure Measurement In the power down state, press and hold the " START/STOP" button, and theninstall the batteries. Until the LCD screen is full, release the " START/STOP" button. When the LCD screen displays the double zero, the bloodpressure meter is in static state. Software version is displayed at the heart rate . mmHg M D Note: Only Service personnel permitted to access to this mode, the mode unavailable in normal use. Unit Operation Bluetooth requirements The monitor requires a device with:
. Bluetooth 4.0 or later
. Android 5.0 or later
. IOS 9.0 or later And works with:
. iphone , iPod, iPad
. Android Phones and Tablets Wireless communication Frequency range : 2.4 Ghz (2400-2483.5 MHz) Modulation : GFSK Antenna gain:0.5dBi 23 Unit Operation Bluetooth connection Using for the first time 1. Download the free JOYTECH healthcare App: On your mobile phone or table 24 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. Pairing your monitor with a Smart Device The date and time on your monitor will automatically be set when you pair it with your smart device. 1. Make sure the Bluetooth in your smart device is turned on. 2. Open the app on your smart device and follow the set-up and pairing instructions. 3. Confirm the monitor is connected successfully. If the monitor is connected successfully to the smart device, bLE on will appear on the monitor display. mmHg
/
Unit Operation Troubleshooting 25 Blood Pressure Information 26 Problem Possible Cause Solution Blood Pressure Cuff is too tight or not properly positioned on the arm Firmly reposition cuff approximately
(
above the elbow joint
( See Page 12) 1-2cm 1/2"
) Blood pressure results are not within typical range Inaccurate test results due to body movement or monitor movement Sit in a relaxed position with arm placed near heart. Avoid speaking or moving body parts while testing. Make sure the monitor unit is placed in a stationary position throughout the testing period.
( See Page 7) Cuff fails to inflate properly Make sure hose is properly fastened to cuff and monitor unit Improper operation Read user manual carefully and re-test properly.
" "displayed Connection failure./
Data is not being transmitted Pressurization is over cuff rated pressure 300mmHg The blood pressure monitor might not be porperly placed within the smart devices tranmission range and is too far from the smart device. Read user manual carefully and re-test properly. If there are no causes of data transmission interference found near the blood pressure monitor, move the blood pressure monitor within 16ft.(5m) of the smart device and try again The blood pressure did not pair successfully to the smart device Try to pair the devices once again. The application on the smart device is not ready. Check the application then try sending the data again. 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 200 150 100 50 g H m m 6 12 18 Time of day 24 Example: fluctuation within a day (male, 35 years old) Blood Pressure Information WHO Blood Pressure Classification Indicator The DBP-1305b is equipped with a classification indicator based on established guidelines from the World Health Organization. The chart below (color coded on monitor unit) indicates test results. 27 Blood Pressure Information Health Reminder 28 Hypertension is a dangerous disease that can affect the quality of life. It can lead to a lot of problems including heart failure, kidney failure, and cerebral hemorrhaging. By maintaining a healthy lifestyle and visiting your physician on a regular basis, hypertension and relative diseases are much easier to control when diagnosed in their Severe Hypertension Moderate Hypertension Mild Hypertension High-n ormal Normal Optimal Mild Hypertension mmHg M D
:
Blood Pressure Classification Indicator early stages. Systolic
( mmHg ) 180 160 140 130 120 Severe Hypertension Moderate Hypertension Mild Hypertension High-normal Normal Optimal 80 85 90 100 110 Diastolic
( mmHg ) Note: Do not be alarmed if an abnormal reading occurs. blood pressure occurs after 2-3 readings are taken at the same time extended period of time. Consult your physican if test results remain abnormal. A better indication of an individual's each day over an Blood Pressure QA 29 Maintenance 1. Avoid dropping, slamming, or throwing the unit. 30 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. Make sure bottom of the cuff is approximately 1-2cm (1/2'') above the elbow joint. 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. 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 arm? What is the difference?
A: Either arm can be used when testing, however, when comparing results, the same arm should be used. Testing on your left arm 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. L U in
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m P g H m m A I D M P O T S T R A T S T E S g H m m S Y S 2. Avoid extreme temperatures. Do not expose unit directly under sunshine. SYS m mHg DIA m mHg PUL
/min M START STOP SET 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. SYS m mHg DIA m mHg PUL
/min M START STOP SET Maintenance 31 Specifications 32 4. Cuff Cleaning and Disinfection:
A) Spread the cuff (skin-contact surface) upwards onto a clean table. Use a damp clean cloth
(water-based) to wipe the skin-contact surface with a force. B) Soak the cloth clean with drinking water and wring it dry. Repeat A) with the damp cloth
(water-based) for 3 times. C) Apply 70%-80% alcohol to a new cloth (or 75% alcohol cotton-ball), use it to wipe the skin-contact surface with a force. Then soak the cloth with the alcohol again
(or change a new 75% alcohol cotton-ball), repeat the disinfection procedure for 3 times. D)When the disinfection towards the skin-contactsurface is finished,wipe thenon-skin contact surface with a cloth (alcohol-based) or alcohol cotton-ball thoroughly for 3 times. E)Leave the cuff naturally dry,then it is ready for reuse. Notice: Do not soak in water or splash water on it. 5. Do not use petrol, thinners or similar solvents. 6. Remove batteries when not in operation for an extended period of time. 7. Do not disassemble product. Product Description Arm-type Fully Automatic Blood Pressure Monitor Model Display DBP-1305b LCD Digital Display Size: 84.1mm55.1mm (3.31" x 2.17" ) Measurement Method Oscillometric Method Systolic Pressure 60mmHg28 0mmHg Diastolic Pressure 30mmHg200mmHg Pressure Pressure 0mmHg300mmHg 3mmHg Measurement Range Pulse 30 ~ 180 Beats/Minute Pulse Automatic Pressurization 5%
120 Memories in Two Groups with Date and Time Irregular Heartbeat Detection Pressurization Memory Function WHO Classification Indicator Last 3 Results Average Low Battery Detection Automatic Power-Off Voice Backlight Bluetooth 4 AA batteries onths at 3 tests per day Approximately 2 m Approx.425g (14.99 oz.) (excluding battery) Approx.166 x 114 x 72mm (6.54" x 4.49" x 2.83" )(L x W x H) Medium cuff: Fits arm circumference 22-36 cm Temperature 10 ~ 40 (50 ~104 ) SYS m mHg DIA m mHg PUL
/min M START STOP SET Power Source Battery Life Unit Weight Unit Dimensions Cuff Circumference 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. Operating Environment Humidity Pressure 15%93%RH 700hPa~1060hPa Maintenance 33 Warranty 34 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 Pressure Monitor due to improper handling. Please contact local retailer for details. Storage Environment Temperature:
Humidity
(-13 ~158
)
-23 ~70 93% RH Classification:
Ingress Protection rating:
Internal Powered Equipment,Type BF . Cuff is the Applied Part IP 20,Indoor Used Only Battery Shelf life:
60 months Battery Storage Temperature:
-25~55 (-13~131) Specifications are subject to change without notice. 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. ANSI/AAMI ISO 81060-2, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type. (Cardiovascular) 3. AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)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. 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. 35 Electromagnetic Compatibility Information The device satisfies the EMC requirements of the international standard IEC 60601-1-2. The requirements are satisfied under the conditions described in the table below. The device is an electrical medical product and is subject to special precautionary measures with regard to EMC which must be published in the instructions for use. Portable and mobile HF communications equipment can affect the device. Use of the unit in conjunction with non-approved accessories can affect the device negatively and alter the electromagnetic compatibility. The device should not be used directly adjacent to or between other electrical equipment. Table 1 Guidance and declaration of manufacturer-electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. 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. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Emissions test Compliance Radiated emission CISPR 11 Group 1, class B. Conducted emission CISPR 11 Group 1, class B. Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Class A Complies Electromagnetic Compatibility Information 36 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 Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV,4 kV, 8 kV, 15 kV air 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 %. Electrostatic transient/burst IEC 61000-4-4 2 kV , 100kHz, for AC power port 2 kV , 100kHz, for AC power port Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 0.5kV, 1kV
(differential mode) 0.5kV, 1kV
(differential mode) Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT;
250/300 cycle 0 % UT;
250/300 cycle Voltage dips, short interrupti-
ons and voltage variations on p-
ower supply in-
put lines IEC 61000-4-11 Electromagnetic Compatibility Information 37 Electromagnetic Compatibility Information 38 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. Table 3 Guidance and declaration of manufacturer-electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-
4-3 IEC 60601 test level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz Compliance level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz 385MHz, 27V
/m 385MHz, 27V
/m 450MHz, 28V
/m 450MHz, 28V
/m 710MHz,745 MHZ,780MHz 9V/m 710MHz,745 MHZ,780MHz 9V/m 810MHz,870 MHZ,930MHz 28V/m 810MHz,870 MHZ,930MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 2450MHz, 28V
/m 2450MHz, 28V
/m 5240MHz,5500 MHZ,5785MHz 9V/m 5240MHz,5500 MHZ,5785MHz 9V/m Electromagnetic environment
-guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended seperation distance 80 MHz to 800 MHz 800 MHz to 2.7 Ghz where P is 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 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 W 0.01 0.1 1 10 100 Separation distance according to frequency of transmitter m 800 MHz to 2.7 GHz 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 80 MHz to 800 MHz 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 th frequency range applies. e higher NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
1 | DBP1307b-FDA Manual | Users Manual | 797.79 KiB |
Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1307b Arm Type Document No.:JDBP-1204-050 VersionZ Date of Issue2018.12 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
......................................................... 06 Unit Illustration
..................................... 08 Important Testing Guidelines Quick Start ................................................................. 09 Unit Operation ........................................................... 10 Battery Installation .................................................. 10 System Settings ........................................................ 11 Applying the Arm Cuff ............................................. 13 Testing ..................................................................... 14 Power Off ................................................................ 17 Memory Check
........................... 18 Memory Deletion ..................................................... 19 Low Battery Indicator ............................................. 19 Bluetooth requirement and connection .............. 20 Troubleshooting ................................................... 22
........................................ 23 Blood Pressure Information
................................................... 26 Blood Pressure QA
............................................................... 27 Maintenance
............................................................. 29 Specifications Warranty .................................................................... 31 Electromagnetic Compatibility Information .............. 32 and Last 3 Test Average Thank you for purchasing the DBP-1307b Blood Pressure Monitor. The unit has been constructed using reliable circuitry and durable materials. Used properly, this unit will provide years of satisfactory use. Measure blood pressure(systolic and diastolic)and pulse rate of adults and adolecents age 12 through 21years of age. All functions can be used safely and values can be read out in one LCD DISPLAY. Measurement position is on adult upper arm 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 81060-2-30) 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 oC, 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 oC, 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. Safety Notice 3 Important Instructions Before Use 1. Do not confuse self-monitoring with self-diagnosis. Blood pressure measurements should only be interpreted by a health professional who is familiar with your medical history. 2. Contact your physician if test results regularly indicate abnormal readings. 3. If you are taking medication, consult with your physician to determine the most appropriate time to measure your blood pressure. NEVER change a prescribed medication without first consulting with your physician. 4. Individuals with serious circulation problems may experience discomfort. Consult your physician prior to use. 5. For persons with irregular or unstable circulation resulting from diabetes, liver disease, arteriosclerosis or other medical conditions, there may be variations in blood pressure values measured at the wrist versus at the upper arm. Monitoring the trends in your blood pressure taken at either the arm or the wrist is nevertheless useful and important. 6. People suffering from vascular constriction, liver disorders or diabetes, people with cardiac pacemakers or a weak pulse, and women who are pregnant should consult their physician before measuring their blood pressure themselves. Different values may be obtained due to their condition. 7. People suffering from arrhythmias such as atrial or ventricular premature beats or atrial fibrillation only use this blood pressure monitor in consultation with your doctor. In certain cases oscillometric measurement method can produce incorrect readings. 8.Too frequent measurements can cause injury to the patient due to blood flow interference. 9.The cuff should not be applied over a wound as this can cause further injury. 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 arm cuff. Do not attempt to repair. 19. Use only the approved arm cuff for this unit. Use of other arm cuffs may result in incorrect measurement results. 20. The system might produce incorrect readings if stored or used outside 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. 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. Safety Notice 4 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. Dispose batteries properly; observe local laws and regulations. 27. Only use a recommended AC adaptor double-insulated complying with EN 60601-1 and EN 60601-1-2. An unauthorized adapter may cause fire and electric shock. 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. Please align the polarities of each battery with the +ve and -ve signs imprinted on the battery housing when you replace the batteries . 32.This ME equipment or ME systems should be only used in shielded location. 33.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. 34.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 the unit, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. WARNING SIGNS AND SYMBOLS USED Keep Dry 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. Safety Notice Federla Commulcation Commission (FCC) Interference Statement 5 Unit Illustration 6 Monitor Unit Blood Pressure Classification Indicator 1.This device complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. 2.This device is verified to comply with part 15 of the FCC Rules for use with cable television service. 3.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. 4.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. LCD Systolic Blood Pressure S Y m m S g H Diastolic Blood Pressure D I A m m H g Pulse Rate P L U
/ m in M E T S S A T R T O P T S Air Jack
" "
M Button
"
"
START/STOP Button
"
"
SET Button Arm Cuff Battery cover AC Adapter Jack Medium size cuff (fits arm circumference: 22.0 cm -36.0 cm). 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 4
. 0 c m (
2
~
1 M R T A F E L
) h c 8 i n
. 0
~
M a i n A r t y r e I N D X E Arm Cuff Air Plug Air Tube If air is leaking from the arm cuff, replace the arm cuff with a new one. It is generally recomm ended to have the cuff replaced timely to ensure correct functioning and accuracy. Please consult your local authorized Sejoy distributor or dealer. Unit Illustration Display Groups Low Battery Indicator WHO Blood Pressure Classification Indicator Results Average in Three Way Irregular Heartbeat Indicator Contents Time Date S Y m m S g H D I A m m H g P L U
/ m in E T S S A T R T O P T S M 1.Monitor Unit Systolic Blood Pressure Diastolic Blood Pressure Pulse Rate mmHg kPa AVG
(( ))
/
No Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1307b Arm Type 2.Owner's Manual 4.Storage Bag 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 4
. 0 c m (
2
~
1 M R T A F E L
) h c 8 i n
. 0
~
M a i n A r t y r e I N D X E 7 Important Testing Guidelines 8 Avoid eating, exercising, and bathing for 30 minutes prior to testing. Sit in a calm environment for at least 5 minutes prior to testing. 1. 2. 3. Do not stand while testing. Sit in a relaxed position while keeping your arm level with your heart. 4. Avoid speaking or moving body parts while testing. 5. While testing, avoid strong electromagnetic interference such as microwave ovens and cell phones. 6. Wait 3 minutes or longer before re-testing. Try to measure your blood pressure at the same time each day for consistency. 7 8
. Test comparisons should only be made when monitor is used on the same arm, 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. Any blood pressure recording can be affected by the following factors:
1. The position of the subject, his or her physiologic condition;
2. The performance and accuracy of the device;
3. Cuff size: too small cuff (bladder) will produce a higher blood pressure value than usual, too big cuff (bladder) will produce a lower blood pressure value;
4. Measuring position does not keep level with your heart;
5. Speaking or moving body parts while testing;
6. Not relaxing for about 5 minutes before taking the measurement. 3.Arm Cuff 5.2MOPPMedical AC Adapter(DC6.0 V,600mA)
(recommended, not provided) Quick Start 9 Unit Operation 10 1. Install batteries 2. Insert cuff air plug into the left side of monitor unit. (See Figure B)
. (See Figure A ) Battery Installation Slide battery cover off as indicated by arrow. Install 4 new AA alkaline batteries according to polarity. Close battery cover. S Y m m S g H D I A m m H g P L U
/ m in E T S S A T R T O P T S M Figure A Figure B 3. Remove thick clothing from the arm area. 4. Rest for several minutes prior to testing. Sit down in a quietplace comfortably , back and arm support on a desk or table ,withyour legs uncrossed ,your arm resting on a firm and your feet flat on the floor. (See Figure C ) Figure C 5. Apply cuff to your left arm and middle of the cuff at the level of your heart. Bottom of cuff should be placed approximately 1-2cm (1/2'') above elbow joint. (See Figures D&E) AC Adapter jack is on the back side of the monitor. Medical AC adapter(DC 6.0 V,600mA) can be used with the device (recommended, not provided). The adapter connect pin should be positive inside and negtive outside with a 2.1mm coaxial joint. Do not use any other type of AC adaptor as it may harm the unit. 1
-
2 c m
(
0.4
-
0.8
''
) Figure D Figure E 6. Press
" START/STOP "
Button to start testing. Note:Power supply is specified as part of ME EQUIPMENT. AC Adapter Jack Unit Operation System Settings 11 Unit Operation 12 3. Time Format setting Press SET button again to set the time fornat setting mode.Set the time format by adjusting theM button. EU means European Time US means U.S Time. With power off, press "SET" button to activate System Settings. The Memory Group icon flashes. 1. Select Memory Group While in the System Setting mode, you may accumulate test results into 2 different groups. This allows multiple users to save individual test results (up to 60 memories per group.) Press " M " button to choose a group setting. Test results will automatically store in each selected group.
/
/
4.Voice Setting Press "SET" button to enter voice setting mode. Set voice format ON or OFF by pressing the "M" button. 2. Time/Date setting PressSET button again to set the Time/Date mode. Set the year first by adjusting the M button. PressSET button again to confirm current month. Continue setting the date, hour and minute in the same way. Every time the SET button is pressed, it will lock in your selection and continue in succession ( month,day,hour, minute) 5.Volume Setting Press "SET" button to enter volume setting mode. Set the voice volume by adjusting the "M" button . There are six volume levels.
/
Unit Operation Applying the Arm Cuff 1. Firmly insert air plug into opening located on left side of monitor unit. S Y m m S g H D I A m m H g P L U
/ m in E T S S A T R T O P T S M 2. With sticky nylon section facing outward, insert end of cuff underneath metal ring
. of cuff 3. Fasten cuff about 1-2cm (0.4-0.8'') above the elbow joint. For best results apply cuff to bare arm and keep level with heart while testing
. 6. Saved Settings While in any setting mode, press " START/STOP " button to turn the unit off. All information will be saved. Note: If unit is left on and not in use for 3 minutes, it will automatically save all information and shut off. 13 Unit Operation 14 Testing 1. Power On second as unit performs a quick diagnosis. testing
. Press and hold "START/STOP" button to turn the unit on. The LCD screen will appear for one A voice tone will indicate when unit is ready for mmHg kPa AVG
(( ))
/
No 1
-
2 c m
(
0.4
-
0.8
''
) Note: Unit will not function if residual air from previous testing is present in cuff. The LCD will flash " " until pressure is stabilized. Note: Do not insert air plug into opening located on right side of monitor unit. This opening is designed for an optional power supply only. Unit Operation 15 Unit Operation 16 2. Pressurization The unit will automatically inflate to the proper pressure value and stop inflating. During this time,please keep quiet. 3. Testing After cuff inflation, air will slowly subside as indicated by the corresponding cuff pressure value. A flashing " " will appear simultaneously on screen signaling heart beat detection. mmHg
/
mmHg
/
Note: Keep relaxed during testing. Avoid speaking or moving body parts. Note: Pressurization will gradually subside and ultimately stop when cuff is not properly applied to the arm. If this occurs, press START/STOP button to turn the unit off. 4. Result Display corresponding WHO Classification. The screen will display measurements for systolic and diastolic blood pressure with voice broadcast. A indicator representing the current measurement will appear next to the Unit Operation 17 Irregular Heartbeat Indicator 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. 5. Deleting/Storing Test Results User may delete their current test result due to unfavorable testing conditions or for any other reason. To delete the last test result, press the "SET" button after result is displayed. If result is not deleted, it will automatically store by date within the previously configured Memory Group. Note: Be sure the appropriate Memory Group selection is made prior to testing. If the number of tests surpasses the allotted 60 memories per group, the most recent tests will appear first, thus eliminating the oldest readings. Power Off turn off the power itself about 3 minutes no operation in any mode. The " START/STOP " button can be pressed to turn off the unit in any mode. The unit can Safety Precaution: If pressure in arm cuff becomes too extreme while testing, press the " START/STOP " button to turn power off. The cuff pressure will rapidly dissipate once the unit is off. Indicator mmHg
/
Note: Refer to Page 23~24 for detail WHO Blood Pressure Classification Information. Unit Operation Last 3 Tests Average With power offpress the "M" 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 "AVG" symbol will appear along with the corresponding WHO Blood Pressure Indicator. The Memory Check mode can be accessed by pressing "M" button. To check the average results from other groups, select the desired group first prior to activating "SET" button in the off position.(See "Select Memory Group" on Page 10) 18 mmHg AVG
/
Memory Check You may check past test results by using the "M" button. The most recent test result and oldest test result in memory can be viewed by pressing and holding the "M" button. Upon activating test results. you can press the "M"
button to scroll through all test results stored in memory. mmHg
/
No
/
Unit Operation Memory Deletion Memory for a selected group may be deleted while in Memory Check mode. Press and hold the " SET " button for approximately 3 seconds to delete all memory records from the selected group. testing mode. Press the "START/STOP " button to turn the unit off. with voice broadcast "Memory Clear"
and then transfer into 19 Note: Memory cannot be recovered once it has been deleted. Low Battery Indicator The unit will broadcast "Low Battery"
testing. The " " appears simultaneously for approximately 5 seconds prior to shutting off. No memory loss will occur throughout this process. when battery life is depleting and unable to inflate cuff for Replace batteries at this time. Unit Operation Static Pressure Measurement In the power down state, press and hold the " START/STOP" button, and theninstall 20 the batteries. Until the LCD screen is full, release the " START/STOP" button. When the LCD screen displays the double zero, the bloodpressure meter is in static state. Software version is displayed at the heart rate . mmHg
/
Note: Only Service personnel permitted to access to this mode, the mode unavailable in normal use. Bluetooth requirements The monitor requires a device with:
. Bluetooth 4.0 or later
. Android 5.0 or later
. IOS 9.0 or later And works with:
. iphone , iPod, iPad
. Android Phones and Tablets Wireless communication Frequency range : 2.4 Ghz (2400-2483.5 MHz) Unit Operation Bluetooth connection Using for the first time 1. Download the free JOYTECH healthcare 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. Pairing your monitor with a Smart Device The date and time on your monitor will automatically be set when you pair it with your smart device. 1. Make sure the Bluetooth in your smart device is turned on. 2. Open the app on your smart device and follow the set-up and pairing instructions. 3. Confirm the monitor is connected successfully. If the monitor is connected successfully to the smart device, bLE on will appear on the monitor display. mmHg
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Modulation : GFSK Antenna gain:0.5dBi 21 Unit Operation Troubleshooting 22 Problem Possible Cause Solution Cuff is too tight or not properly positioned on the arm Firmly reposition cuff approximately
(
above the elbow joint
( See Page 12) 1-2cm 1/2"
) Blood pressure results are not within typical range Inaccurate test results due to body movement or monitor movement Sit in a relaxed position with arm placed near heart. Avoid speaking or moving body parts while testing. Make sure the monitor unit is placed in a stationary position throughout the testing period.
( See Page 7) Cuff fails to inflate properly Make sure hose is properly fastened to cuff and monitor unit Improper operation Read user manual carefully and re-test properly.
" "displayed Connection failure./
Data is not being transmitted Pressurization is over cuff rated pressure 300mmHg The blood pressure monitor might not be porperly placed within the smart devices tranmission range and is too far from the smart device. Read user manual carefully and re-test properly. If there are no causes of data transmission interference found near the blood pressure monitor, move the blood pressure monitor within 16ft.(5m) of the smart device and try again The blood pressure did not pair successfully to the smart device Try to pair the devices once again. The application on the smart device is not ready. Check the application then try sending the data again. Blood Pressure Information 23 Blood Pressure Information 24 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 200 150 100 50 g H m m 6 12 18 Time of day 24 Example: fluctuation within a day (male, 35 years old) WHO Blood Pressure Classification Indicator The DBP-1307b is equipped with a classification indicator based on established guidelines from the World Health Organization. The chart below (color coded on monitor unit) indicates test results. Severe Hypertension Moderate Hypertension Mild Hypertension High-n ormal Normal Optimal Mild Hypertension mmHg
/
:
Blood Pressure Classification Indicator Blood Pressure Information 25 Blood Pressure QA 26 Health Reminder Hypertension is a dangerous disease that can affect the quality of life. It can lead to a lot of problems including heart failure, kidney failure, and cerebral hemorrhaging. By maintaining a healthy lifestyle and visiting your physician on a regular basis, hypertension and relative diseases are much easier to control when diagnosed in their early stages. Systolic
( mmHg ) 180 160 140 130 120 Severe Hypertension Moderate Hypertension Mild Hypertension High-normal Normal Optimal 80 85 90 100 110 Diastolic
( mmHg ) Note: Do not be alarmed if an abnormal reading occurs. blood pressure occurs after 2-3 readings are taken at the same time extended period of time. Consult your physician if test results remain abnormal. A better indication of an individual's each day over an 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. Make sure bottom of the cuff is approximately 1-2cm (1/2'') above the elbow joint. 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. 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 arm? What is the difference?
A: Either arm can be used when testing, however, when comparing results, the same arm should be used. Testing on your left arm 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. Maintenance 1. Avoid dropping, slamming, or throwing the unit. STOP START M
/min PUL mmHg DIA S ET mmHg SYS 2. Avoid extreme temperatures. Do not expose unit directly under sunshine. SYS mmHg DIA mmHg PUL
/min SET START STOP M 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. SYS mmHg DIA mmHg PUL
/min SET START STOP M 27 Maintenance 28 4. Cuff Cleaning and Disinfection:
A) Spread the cuff (skin-contact surface) upwards onto a clean table. Use a damp clean cloth
(water-based) to wipe the skin-contact surface with a force. B) Soak the cloth clean with drinking water and wring it dry. Repeat A) with the damp cloth
(water-based) for 3 times. C) Apply 70%-80% alcohol to a new cloth (or 75% alcohol cotton-ball), use it to wipe the skin-contact surface with a force. Then soak the cloth with the alcohol again
(or change a new 75% alcohol cotton-ball), repeat the disinfection procedure for 3 times. D)When the disinfection towards the skin-contactsurface is finished,wipe thenon-skin contact surface with a cloth (alcohol-based) or alcohol cotton-ball thoroughly for 3 times. E)Leave the cuff naturally dry,then it is ready for reuse. Notice: Do not soak in water or splash water on it. 5. Do not use petrol, thinners or similar solvents. 6. Remove batteries when not in operation for an extended period of time. 7. Do not disassemble product. SYS mmHg DIA mmHg PUL
/min SET START STOP M 8. It is recommended the performance should be checked every 2 years. 9. Expected service life: Approximately three years at 10 tests per day. 10.No service and maintenance while it is in use and maintenance only be performed by service personnel. Service and maintenance require parts, repair, technical support will be provided. Specifications 29 Specifications 30 Product Description Arm-type Fully Automatic Blood Pressure Monitor Operating Environment Pressure 700hPa~1060hPa Model Display DBP-1307b LCD Digital Display Size: 102mm68.9mm (4.02" x 2.71" ) Measurement Method Oscillometric Method Systolic Pressure 60mmHg28 0mmHg Diastolic Pressure 30mmHg200mmHg Pressure Pressure 0mmHg300mmHg 3mmHg Measurement Range Pulse 30 ~ 180 Beats/Minute Pulse 5%
Pressurization Automatic Pressurization Memory Function Power Source Battery Life Unit Weight Unit Dimensions 120 Memories in Two Groups with Date and Time Irregular Heartbeat Detection WHO Classification Indicator Last 3 Tests Average Low Battery Detection Automatic Power-Off Voice Backlight Bluetooth 4 AA batteries or Medical AC Adapter(DC6.0V, 600mA)
(recommended, not provided) Approximately 2 m Approx.488g (17.21 oz.) (excluding battery) Approx.166 x 114 x 72mm (6.53" x 4.49" x 2.83" )(L x W x H) at 3 tests per day onths Cuff Circumference Medium cuff: Fits arm circumference 22-36 cm Operating Environment Humidity Temperature 10 ~ 40 (50 ~104 ) 15% ~ 93% RH Temperature:
-25 ~70
(-13 ~158
) Storage Environment Humidity 93% RH Classification:
Ingress Protection rating:
Internal Powered Equipment,Type BF . Cuff is the Applied Part IP 20,Indoor Used Only Battery Shelf life:
60 months Battery Storage Temperature:
-25~55 (-13~131) Specifications are subject to change without notice. 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. ANSI/AAMI ISO 81060-2, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type. (Cardiovascular) 3. AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)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. Correct Disposal of This Product
(Waste Electrical & Electronic Equipment) This marking shown on the product indicates that it should not be disposed with other household waste at the end of its life. To prevent potential harm to the environment or to human health, please separate this product from other types of wastes and recycle it responsibly. When disposing this type of product, contact the retailer where product was purchased or contact your local government office for details regarding how this item can be disposed in an environmentally safe recycling center. Business users should contact their supplier and check the terms and conditions of the purchasing agreement. This product should not be mixed with other commercial wastes for disposal. This product is free of hazardous materials. Warranty 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 Pressure Monitor due to improper handling. Please contact local retailer for details. 31 32 Electromagnetic Compatibility Information The device satisfies the EMC requirements of the international standard IEC 60601-1-2. The requirements are satisfied under the conditions described in the table below. The device is an electrical medical product and is subject to special precautionary measures with regard to EMC which must be published in the instructions for use. Portable and mobile HF communications equipment can affect the device. Use of the unit in conjunction with non-approved accessories can affect the device negatively and alter the electromagnetic compatibility. The device should not be used directly adjacent to or between other electrical equipment. Table 1 Guidance and declaration of manufacturer-electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. 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. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Emissions test Compliance Radiated emission CISPR 11 Group 1, class B. Conducted emission CISPR 11 Group 1, class B. Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Class A Complies 33 Electromagnetic Compatibility Information 34 Table 3 Guidance and declaration of manufacturer-electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-
4-3 IEC 60601 test level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz Compliance level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz 385MHz, 27V
/m 385MHz, 27V
/m 450MHz, 28V
/m 450MHz,
/m 28V 710MHz,745 MHZ,780MHz 9V/m 710MHz,745 MHZ,780MHz 9V/m 810MHz,870 MHZ,930MHz 28V/m 810MHz,870 MHZ,930MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 2450MHz, 28V
/m 2450MHz, 28V
/m 5240MHz,5500 MHZ,5785MHz 9V/m 5240MHz,5500 MHZ,5785MHz 9V/m Electromagnetic environment
-guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended seperation distance 80 MHz to 800 MHz 800 MHz to 2.7 Ghz where P is the maximum output power rating of the transmitter in watts (W) according to the transm-
itter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:
Electromagnetic Compatibility Information 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 Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV,4 kV, 8 kV, 15 kV air 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 %. Electrostatic transient/burst IEC 61000-4-4 2 kV , 100kHz, for AC power port 2 kV , 100kHz, for AC power port Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 0.5kV, 1kV
(differential mode) 0.5kV, 1kV
(differential mode) Mains power quality should be that of a typical commercial or hospital environment. 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT;
250/300 cycle 0 % UT;
250/300 cycle Voltage dips, short interrupti-
ons and voltage variations on p-
ower supply in-
put lines IEC 61000-4-11 Mains power quality should be that of a typical commercial or hospital environment. 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 35 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 W 0.01 0.1 1 10 100 Separation distance according to frequency of transmitter m 800 MHz to 2.7 GHz 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 80 MHz to 800 MHz 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 th frequency range applies. e higher NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
1 | DBP1318b-FDA Manual | Users Manual | 1009.65 KiB |
Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1318b Arm Type Document No.: JDBP-2604-050 VersionZ Date of Issue2018.12 m m H g M D 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
......................................................... 06 Unit Illustration
..................................... 09 Important Testing Guidelines 10 Quick Start ................................................................. Unit Operation ........................................................... 11 Battery Installation .................................................. 11 Time/Date Setting ....................................................... 12 Applying the Arm Cuff ............................................. 13 Testing ..................................................................... 14 Power Off ................................................................ 16 Memory Check .......................................................... 17 Memory Deletion ..................................................... 18 Last 3 Test Average .................................................... 17 Bluetooth connection .......................................... ... 20 Troubleshooting ...................................................... 21 Blood Pressure Information ........................................ 22 Blood Pressure QA ................................................... 25 Maintenance ............................................................... 26 Specifications ............................................................. 28 Warranty .................................................................... 30 Electromagnetic Compatibility Information ................ 31 Thank you for purchasing the DBP-1318b Blood Pressure Monitor. The unit has been constructed using reliable circuitry and durable materials. Used properly, this unit will provide yeas of satisfactory use. Measure blood pressure(systolic and diastolic)and pulse rate of adults and adolecents age 12 through 21years of age. LCD DISPLAY. Measurement position is on adult upper arm only. The PATIENT is an intended OPERATOR All functions can be used safely and values can be read out in one 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 81060-2-30) 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 oC, 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 oC, 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. Safety Notice 3 Safety Notice 4 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. 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 arm cuff. Do not attempt to repair. 19. Use only the approved arm cuff for this unit. Use of other arm cuffs may result in incorrect measurement results. 20. The system might produce incorrect readings if stored or used outside 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. 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. Dispose batteries properly; observe local laws and regulations. 27. Only use a recommended AC adaptor double-insulated complying with EN 60601-1 and EN 60601-1-2. An unauthorized adapter may cause fire and electric shock. 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. Please align the polarities of each battery with the +ve and -ve signs imprinted on the battery housing when you replace the batteries . 32.This ME equipment or ME systems should be only used in shielded location. 33.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. 34.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 the unit, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. WARNING SIGNS AND SYMBOLS USED Keep Dry 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. 5 Unit Illustration 6 Safety Notice Federla Commulcation Commission (FCC) Interference Statement 1.This device complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. 2.This device is verified to comply with part 15 of the FCC Rules for use with cable television service. 3.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. 4.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. Monitor Unit Blood Pressure Classification Indicator LCD Systolic Blood Pressure Diastolic Blood Pressure Pulse Rate Air Jack
"
MODE Button
"
ON/OFF
"
"
Button SET
"
"
Button Battery cover Unit Illustration 7 Unit Illustration 8 Arm Cuff Medium size cuff (fits arm circumference: 22.0 cm -36.0 cm). Contents Contents 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 0 . 4 c m (
2
~
1 M R T A F E L
) h c n 0 . 8 i
~
M a i n A r t y r e I N D X E Arm Cuff Air Plug Air Tube If air is leaking from the arm cuff, replace the arm cuff with a new one. It is generally recommended to have the cuff replaced timely to ensure correct functioning and accuracy. Please consult your local authorized distributor or dealer. 1.Monitor Unit Display Groups Low Battery Indicator WHO Blood Pressure Classification Indicator Last 3 Results Average Irregular Heartbeat Indicator Time Date Systolic Blood Pressure Diastolic Blood Pressure Pulse Rate 3.Arm Cuff Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1318b Arm Type m m H g M D 2.Owner's Manual 4.Storage Case Important Testing Guidelines 9 Quick Start 10 5.2MOPPMedical AC Adapter(DC6.0 V,600mA)
(recommended, not provided) Avoid eating, exercising, and bathing for 30 minutes prior to testing. 1. 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 arm level with your heart. 4. Avoid speaking or moving body parts while testing. 5. While testing, avoid strong electromagnetic interference such as microwave ovens and cell phones. 6. Wait 3 minutes or longer before re-testing. 7. Try to measure your blood pressure at the same time each day for consistency. 8. Test comparisons should only be made when monitor is used on the same arm, 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. Any blood pressure recording can be affected by the following factors:
1. The position of the subject, his or her physiologic condition;
2. The performance and accuracy of the device;
3. Cuff size: too small cuff (bladder) will produce a higher blood pressure value than usual, too big cuff (bladder) will produce a lower blood pressure value;
4. Measuring position does not keep level with your heart;
5. Speaking or moving body parts while testing;
6. Not relaxing for about 5 minutes before taking the measurement. 1. Install batteries 2. Insert cuff air plug into the left side of monitor unit. (See Figure B)
. (See Figure A ) Figure A 3. Remove thick clothing from the arm area. 4. Rest for several minutes prior to testing. Sit down in a quietplace comfortably , back and arm support on a desk or table ,withyour legs uncrossed ,your arm resting on a firm and your feet flat on the floor. (See Figure C ) Figure B Figure C 5. Apply cuff to your left arm and middle of the cuff at the level of your heart. Bottom of cuff should be placed approximately 1-2cm (1/2'') above elbow joint. (See Figures D&E) 1
-
2 c m
(
0.4
-
0.8
''
) Figure D Figure E 6. Press
"ON/OFF "
Button to start testing. Unit Operation Battery Installation Slide battery cover off as indicated by arrow. Install 4 new AAA alkaline batteries according to polarity. Close battery cover. 11 Unit Operation System Settings With power off, press SET button to actuate system setting, the Memory Group icon flashes. 1. Select memory Group While in the System Setting mode you may accumulate test results into 2 different groups. Press MODE button to choose a group setting. The test results will automatically store in each selected group. 12 AC adapter jack is on the right side of the monitor. Medical AC adapter(DC 6.0 V,600mA) can be used with the device (recommended, not provided). The adapter connect pin should be positive inside and negative outside with a 2.1mm coaxial joint. Do not use another type of AC adaptor as it may harm the unit. 2. Time /Date Setting Press "SET" button again to set the Time/Date mode. Set the month firstly by adjusting the
"MODE " button. Press "SET" button again to confirm current month. Continue setting the day, hour, and minute in the same way. Every time the "SET" button is pressed, it will lock in your selection and continue in succession (month, day, hour, minute.) AC adapter Jack Note:Power supply is specified as part of ME EQUIPMENT. Unit Operation Applying the Arm Cuff 1. Firmly insert air plug into opening located on left side of monitor unit. M D 3. Save settings. While in any setting mode, press "ON/OFF" button to turn the unit off. All information will be saved. NoteIf unit is left on and not in use for 3 minutes,it will automatically save all information and shut off. 13 Unit Operation Testing 14 Press and hold 1. Power On appear for one second as unit performs a quick diagnosis. A long tone indicates device is ready for testing. button until a beep sounds. The LCD screen will
"ON/OFF"
2. With sticky nylon section facing outward, insert end of cuff underneath metal ring
. of cuff 3. Fasten cuff about 1-2cm (0.4-0.8'') above the elbow joint. For best results apply cuff to bare arm and keep level with heart while testing
. 1
-
2 c m
(
0.4
-
0.8
''
) Note: Unit will not function if residual air from previous testing is present in cuff. The LCD will flash " " until pressure is stabilized. 2. Pressurization The unit will automatically inflate to the proper pressure value and stop inflating. During this time,please keep quiet. Note: Do not insert air plug into opening located on right side of monitor unit. This opening is designed for an optional power supply only. mmHg M D Note: Pressurization will gradually subside and ultimately stop when cuff is not properly applied to the arm. If this occurs, press ON/OFF button to turn the unit off. Unit Operation 15 Unit Operation 16 3. Testing After cuff inflation, air will slowly subside as indicated by the corresponding cuff pressure value. A flashing " " will appear simultaneously on screen signaling heart beat detection. mmHg M D Note: Keep relaxed during testing. Avoid speaking or moving body parts. 4. Result Display Three short beeps sound when testing is complete. The screen will display measurements for systolic and diastolic blood pressure. An indicator representing the current measurement will appear next to the corresponding WHO Classification. Indicator Note: Refer to detaile d WHO Blood Pressure Classification Information. Irregular Heartbeat Indicator If the monitor detects an irregular heart rhythm two or more times during the measuring process, the Irregular Heartbeat Symbol " "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. 5. Deleting/Storing Test Results User may delete their current test result due to unfavorable testing conditions or for any other reason. To delete the last test result, press the "SET" button after result is displayed. If result is not deleted, it will automatically store by date within the previously configured Memory Group. Note: Be sure the appropriate Memory Group selection is made prior to testing. If the number of tests surpasses the allotted 60 memories per group, the most recent tests will appear first, thus eliminating the oldest readings. Power Off turn off the power itself about 3 minutes no operation in any mode. The "ON/OFF" button can be pressed to turn off the unit in any mode. The unit can Safety Precaution: If pressure in arm 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. Unit Operation Last 3 Tests Average With power off, press the " M " button to activatescreen 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 " AV G " symbol will appear along with the corresponding WHO Blood Pressure Indicator. The Memory Check mode can be accessed by pressing "MODE" button. To check the average results from other groups, you must firstly select the desired group and then turn monitor off.
(See "Select Memory Group") 17 Unit Operation 18 Memory Deletion Memory for a selected group may be deleted while in Memory Check mode. Press and hold the "SET" button for approximately 3 seconds to delete all memory records from the selected group. The monitor will beep indicating successful deletion and then transfer into testing mode. Press the "ON/OFF" button to turn the unit off. If the memory is less than 3 groups, press the "MODE" button to memory check mode. Note: Memory cannot be recovered once it has been deleted. Memory Check While in last 3 tests average mode, press "MODE"button again, you may check the last test results. The most recent test result and oldest test result in memory can be viewed by pressing and holding the "MODE" button. Upon activating test results, you can press the "MODE"
button to scroll through all test results stored in memory. Low Battery Indicator 4 short warning beeps sound when battery life is depleting and unable to inflate cuff for testing. The " " appears simultaneously for approximately 5 seconds prior to shutting off. Replace batteries at this time. No memory loss will occur throughout this process. D No M NotePrevious test will only be displayed from the most recently used memory group. To check previous test results in other memory groups, you must first select the desired group and then turn monitor off. (See "Select Memory Group") Unit Operation Static Pressure Measurement In the power down state, press and hold the " ON/OFF " button, and theninstall the batteries. 19 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 at the heart rate . Note: Only Service personnel permitted to access to this mode, the mode unavailable in normal use. Bluetooth requirements The monitor requires a device with:
. Bluetooth 4.0 or later
. Android 5.0 or later
. IOS 9.0 or later And works with:
. iphone , iPod, iPad
. Android Phones and Tablets Wireless communication Frequency range : 2.4 Ghz (2400-2483.5 MHz) Modulation : GFSK Antenna gain:0.5dBi Unit Operation Troubleshooting Problem Possible Cause Solution Cuff is too tight or not properly positioned on the arm Firmly reposition cuff approximately
(
above the elbow joint
( See Page 12) 1-2cm 1/2"
) Blood pressure results are not within typical range Inaccurate test results due to body movement or monitor movement Sit in a relaxed position with arm placed near heart. Avoid speaking or moving body parts while testing. Make sure the monitor unit is placed in a stationary position throughout the testing period.
( See Page 7) Unit Operation 20 Bluetooth connection Using for the first time 1. Download the free JOYTECH healthcare 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. Pairing your monitor with a Smart Device The date and time on your monitor will automatically be set when you pair it with your smart device. 1. Make sure the Bluetooth in your smart device is turned on. 2. Open the app on your smart device and follow the set-up and pairing instructions. 3. Confirm the monitor is connected successfully. If the monitor is connected successfully to the smart device, bLE on will appear on the monitor display. mmHg
/
21 Blood Pressure Information 22 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. Cuff fails to inflate properly Make sure hose is properly fastened to cuff and monitor unit If these measuring numbers become too high, it means the heart is working harder than it should. Improper operation Read user manual carefully and re-test properly.
" "displayed Connection failure./
Data is not being transmitted Pressurization is over cuff rated pressure 300mmHg The blood pressure monitor might not be porperly placed within the smart devices tranmission range and is too far from the smart device. Read user manual carefully and re-test properly. If there are no causes of data transmission interference found near the blood pressure monitor, move the blood pressure monitor within 16ft.(5m) of the smart device and try again The blood pressure did not pair successfully to the smart device Try to pair the devices once again. The application on the smart device is not ready. Check the application then try sending the data again. 200 150 100 50 g H m m Upper curve : systolic blood pressure Lower curve: diastolic blood pressure 6 12 18 Time of day 24 Example: fluctuation within a day (male, 35 years old) Blood Pressure Information 23 Blood Pressure Information 24 WHO Blood Pressure Classification Indicator The DBP-1318b is equipped with a classification indicator based on established guidelines from the World Health Organization. The chart below (color coded on monitor unit) indicates test results. Health Reminder Hypertension is a dangerous disease that can affect the quality of life. It can lead to a lot of problems including heart failure, kidney failure, and cerebral hemorrhaging. By maintaining a healthy lifestyle and visiting your physician on a regular basis, hypertension and relative diseases are much easier to control when diagnosed in their Severe Hypertension Moderate Hypertension Mild Hypertension High-n ormal Normal Optimal Mild Hypertension
:
Blood Pressure Classification Indicator early stages. Systolic
( mmHg ) 180 160 140 130 120 Severe Hypertension Moderate Hypertension Mild Hypertension High-normal Normal Optimal 80 85 90 100 110 Diastolic
( mmHg ) Note: Do not be alarmed if an abnormal reading occurs. blood pressure occurs after 2-3 readings are taken at the same time extended period of time. Consult your physician if test results remain abnormal. A better indication of an individual's each day over an Blood Pressure QA 25 Maintenance 26 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. Make sure bottom of the cuff is approximately 1-2cm (1/2'') above the elbow joint. 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. 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 arm? What is the difference?
A: Either arm can be used when testing, however, when comparing results, the same arm should be used. Testing on your left arm 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 expose unit directly under sunshine. 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. Maintenance 27 Specifications 28 4. Cuff Cleaning and Disinfection:
A) Spread the cuff (skin-contact surface) upwards onto a clean table. Use a damp clean cloth
(water-based) to wipe the skin-contact surface with a force. B) Soak the cloth clean with drinking water and wring it dry. Repeat A) with the damp cloth
(water-based) for 3 times. C) Apply 70%-80% alcohol to a new cloth (or 75% alcohol cotton-ball), use it to wipe the skin-contact surface with a force. Then soak the cloth with the alcohol again
(or change a new 75% alcohol cotton-ball), repeat the disinfection procedure for 3 times. D)When the disinfection towards the skin-contactsurface is finished,wipe thenon-skin contact surface with a cloth (alcohol-based) or alcohol cotton-ball thoroughly for 3 times. E)Leave the cuff naturally dry,then it is ready for reuse. Notice: Do not soak in water or splash water on it. 5. Do not use petrol, thinners or similar solvents. 6. Remove batteries when not in operation for an extended period of time. 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. Product Description Arm-type Fully Automatic Blood Pressure Monitor Model Display DBP-1318b LCD Digital Display Size: 66mm x 43mm (2.60" x 1.69") Measurement Method Oscillometric Method Systolic Pressure 60mmHg28 0mmHg Diastolic Pressure 30mmHg200mmHg Pressure Pressure 0mmHg300mmHg 3mmHg Measurement Range Pulse 30 ~ 180 Beats/Minute Pulse Automatic Pressurization 5%
120 Memories in Two Groups with Date and Time Irregular Heartbeat Detection WHO Classification Indicator Last 3 Tests Average Low Battery Detection Pressurization Memory Function Automatic Power-Off Bluetooth 4 AAA batteries or Medical AC Adapter(DC6.0V, 600mA)
(recommended, not provided) Approximately 2 m at 3 tests per day Approx.317g (11.18 oz.) (excluding battery) Approx.139 x 88 x 43mm (5.47" x 3.46" x 1.69") (L x W x H) onths Power Source Battery Life Unit Weight Unit Dimensions Cuff Circumference Medium cuff: Fits arm circumference 22-36 cm Temperature Operating Environment Humidity 10 ~ 40 (50 ~104 15% ~ 93% RH
) Pressure 700hPa~1060hPa Specifications 29 Warranty 30 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 Pressure Monitor due to improper handling. Please contact local retailer for details. Temperature:
-25 ~70
(-13 ~158
) Storage Environment Humidity 93% RH Classification:
Ingress Protection rating:
Internal Powered Equipment,Type BF . Cuff is the Applied Part IP 20,Indoor Used Only Battery Shelf life:
60 months Battery Storage Temperature:
-25~55 (-13~131) Specifications are subject to change without notice. 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. ANSI/AAMI ISO 81060-2, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type. (Cardiovascular) 3. AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)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. 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. 31 Electromagnetic Compatibility Information The device satisfies the EMC requirements of the international standard IEC 60601-1-2. The requirements are satisfied under the conditions described in the table below. The device is an electrical medical product and is subject to special precautionary measures with regard to EMC which must be published in the instructions for use. Portable and mobile HF communications equipment can affect the device. Use of the unit in conjunction with non-approved accessories can affect the device negatively and alter the electromagnetic compatibility. The device should not be used directly adjacent to or between other electrical equipment. Table 1 Guidance and declaration of manufacturer-electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. 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. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Emissions test Compliance Radiated emission CISPR 11 Group 1, class B. Conducted emission CISPR 11 Group 1, class B. Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Class A Complies Electromagnetic Compatibility Information Table 2 32 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 Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV,4 kV, 8 kV, 15 kV air 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 %. Electrostatic transient/burst IEC 61000-4-4 2 kV , 100kHz, for AC power port 2 kV , 100kHz, for AC power port Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 0.5kV, 1kV
(differential mode) 0.5kV, 1kV
(differential mode) Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT;
250/300 cycle 0 % UT;
250/300 cycle Voltage dips, short interrupti-
ons and voltage variations on p-
ower supply in-
put lines IEC 61000-4-11 Electromagnetic Compatibility Information 33 Electromagnetic Compatibility Information 34 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. Table 3 Guidance and declaration of manufacturer-electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-
4-3 IEC 60601 test level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz Compliance level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz 385MHz, 27V
/m 385MHz, 27V
/m 450MHz, 28V
/m 450MHz, 28V
/m 710MHz,745 MHZ,780MHz 9V/m 710MHz,745 MHZ,780MHz 9V/m 810MHz,870 MHZ,930MHz 28V/m 810MHz,870 MHZ,930MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 2450MHz, 28V
/m 2450MHz, 28V
/m 5240MHz,5500 MHZ,5785MHz 9V/m 5240MHz,5500 MHZ,5785MHz 9V/m Electromagnetic environment
-guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended seperation distance 80 MHz to 800 MHz 800 MHz to 2.7 Ghz where P is 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 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 W 0.01 0.1 1 10 100 Separation distance according to frequency of transmitter m 800 MHz to 2.7 GHz 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 80 MHz to 800 MHz 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 th frequency range applies. e higher NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
1 | DBP1319b-FDA Manual | Users Manual | 927.91 KiB |
Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1319b Arm Type Document No.:JDBP-2704-050 Version: Z Date of Issue: 2018.12 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 Safety Notice 2 Thank you for purchasing the DBP-1319b Blood Pressure Monitor. The unit has been constructed using reliable circuitry and durable materials. Used properly, this unit will provide yeas of satisfactory use
. Measure blood pressure(systolic and diastolic)and pulse rate of adults and adolecents age 12 through 21years of age. All functions can be used safely and values can be read out in one LCD DISPLAY. Measurement position is on adult upper arm 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 81060-2-30) 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 oC, 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 oC, 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. 1 Contents Safety Notice ............................................................... 02 Unit Illustration ......................................................... 06 Important Testing Guidelines ..................................... 09 Quick Start ................................................................. 10 Unit Operation ........................................................... 11 Battery Installation .................................................. 11 System Settings ........................................................ 12 Applying the Arm Cuff ............................................. 14 Testing ..................................................................... 17 Power Off ................................................................ 18 Last3 Tests Average .......... ...................................... 18 Memory Check ...................................................... 19 Memory Deletion ..................................................... 20 Low Battery Indicator ............................................. 21 Bluetooth requirements ........................................... 23 Troubleshooting ...................................................... 24 Blood Pressure Information ........................................ 25 Blood Pressure Q A ................................................... 28 Maintenance ............................................................... 29 Specifications ............................................................. 31 Warranty .................................................................... 33 Electromagnetic Compatibility Information ............... 34 Safety Notice 3 Safety Notice 4 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. 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 arm cuff. Do not attempt to repair. 19. Use only the approved arm cuff for this unit. Use of other arm cuffs may result in incorrect measurement results. 20. The system might produce incorrect readings if stored or used outside 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. 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. Dispose batteries properly; observe local laws and regulations. 27. Only use a recommended AC adaptor double-insulated complying with EN 60601-1 and EN 60601-1-2. An unauthorized adapter may cause fire and electric shock. 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. Please align the polarities of each battery with the +ve and -ve signs imprinted on the battery housing when you replace the batteries . 32.This ME equipment or ME systems should be only used in shielded location. 33.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. 34.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 the unit, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. WARNING SIGNS AND SYMBOLS USED Keep Dry 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. Safety Notice Federla Commulcation Commission (FCC) Interference Statement 5 Unit Illustration 6 1.This device complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. 2.This device is verified to comply with part 15 of the FCC Rules for use with cable television service. 3.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. 4.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. Monitor Unit Blood Pressure Classification Indicator LCD S H g m Y m S Systolic Blood Pressure Diastolic Blood Pressure H g Pulse Rate D IA m m P U L m m H g M T S T O P R T A S T E S Air Jack
" "
M Button
"
"
START/STOP Button
"
"
SET Button Battery cover AC Adapter Jack Unit Illustration Arm Cuff Medium size cuff (fits arm circumference: 22.0 cm -36.0 cm). 7 Unit Illustration 8 M R T A
) h F c E L 8 i n
. 0
~
M a i n A r t e y r I N X E D Contents S H g m Y m S D IA m m H g P U L m m H g Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1319b Arm Type 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 4
. 0 c m (
2
~
1 Arm Cuff Air Plug Air Tube M T S T O P R T A S T E S If air is leaking from the arm cuff, replace the arm cuff with a new one. It is generally recommended to have the cuff replaced timely to ensure correct functioning and accuracy. Please consult your local authorized distributor or dealer. 1.Monitor Unit 2.Owner's Manual Display Groups Low Battery Indicator WHO Blood Pressure Classification Indicator Last 3 Results Average Irregular Heartbeat Indicator Time Date mmHg kPa AVG
(( ))
/
No Systolic Blood Pressure Diastolic Blood Pressure Pulse Rate M R T A F E
) h c 8 i n L
. 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 0
~
4
. 0 c m (
2
~
1 i n A r M a y r e t I N X E D 3.Arm Cuff 4.Storage Bag 5.2MOPPMedical AC Adapter(DC6.0 V,600mA)
(recommended, not provided) Important Testing Guidelines 9 Quick Start 10 Avoid eating, exercising, and bathing for 30 minutes prior to testing. Sit in a calm environment for at least 5 minutes prior to testing. 1. 2. Do not stand while testing. Sit in a relaxed position while keeping your arm level with 3 your heart. 4. Avoid speaking or moving body parts while testing. 5. While testing, avoid strong electromagnetic interference such as microwave ovens and cell phones. 6
. Wait 3 minutes or longer before re-testing. Try to measure your blood pressure at the same time each day for consistency. 7 8
. Test comparisons should only be made when monitor is used on the same arm, 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. 1. Install batteries 2. Insert cuff air plug into the left side of monitor unit. (See Figure B)
. (See Figure A ) S S H g Y m m D I A m m g H P L H g U m m M T E S S A T R T O P T S Figure A Figure B 3. Remove thick clothing from the arm area. 4. Rest for several minutes prior to testing. Sit down in a quietplace comfortably , back and arm support on a desk or table ,withyour legs uncrossed ,your arm resting on a firm and your feet flat on the floor. (See Figure C ) Any blood pressure recording can be affected by the following factors:
1. The position of the subject, his or her physiologic condition;
2. The performance and accuracy of the device;
3. Cuff size: too small cuff (bladder) will produce a higher blood pressure value than usual, too big cuff (bladder) will produce a lower blood pressure value;
4. Measuring position does not keep level with your heart;
5. Speaking or moving body parts while testing;
6. Not relaxing for about 5 minutes before taking the measurement. Figure C 5. Apply cuff to your left arm and middle of the cuff at the level of your heart. Bottom of cuff should be placed approximately 1-2cm (1/2'') above elbow joint. (See Figures D&E) 1
-
2 c m
(
0.4
-
0.8
''
) Figure D Figure E 6. Press " START/STOP " Button to start testing. Unit Operation Battery Installation Slide battery cover off as indicated by arrow. Install 4 new AA alkaline batteries according to polarity. Close battery cover. 11 12 Unit Operation System Settings With power off, press "SET" button to activate System Settings. The Memory Group icon flashes. 1. Select Memory Group While in the System Setting mode, you may accumulate test results into 2 different groups. This allows multiple users to save individual test results (up to 60 memories per group.) Press " M " button to choose a group setting. Test results will automatically store in each selected group. AC Adapter jack is on the back side of the monitor. Medical AC adapter(DC 6.0 V,600mA) can be used with the device (recommended, not provided). The adapter connect pin should be positive inside and negtive outside with a 2.1mm coaxial joint. Do not use any other type of AC adapter as it may harm the unit. 2. Time/Date setting PressSET button again to set the Time/Date mode. Set the year first by adjusting the M button. PressSET button again to confiom curret month:Continue setting the date, hour and minute in the same way Every time the SET button is pressed, it will lock in your selection and continue in succession ( month,day,hour, minute) AC Adapter Jack Note:Power supply is specified as part of ME EQUIPMENT. Unit Operation
/
3. Time Format setting Press SET button again to set the time fornat setting mode.Set the time format by adjusting theM button. EU means European Time US means U.S Time. 13 Unit Operation Applying the Arm Cuff 1. Firmly insert air plug into opening located on left side of monitor unit. 14
/
/
S S H g Y m m D I A m m g H 4.Voice Setting Press "SET" button to enter voice setting mode. Set voice format ON or OFF by pressing the "M" button. P L H g U m m M T E S S A T R T O P T S 5.Volume Setting Press "SET" button to enter volume setting mode. Set the voice volume by adjusting the "M" button . There are six volume levels. 6. Saved Settings While in any setting mode, press " START/STOP " button to turn the unit off. All information will be saved. Note: If unit is left on and not in use for 3 minutes, it will automatically save all information and shut off. 2. With sticky nylon section facing outward, insert end of cuff underneath metal ring
. of cuff 3. Fasten cuff about 1-2cm (0.4-0.8'') above the elbow joint. For best results apply cuff to bare arm and keep level with heart while testing
. 1
-
2 c m
(
0.4
-
0.8
''
) Note: Do not insert air plug into opening located on right side of monitor unit. This opening is designed for an optional power supply only. Unit Operation 15 Unit Operation 16 Testing 1. Power On Press and hold "START/STOP" button to turn the unit on. The LCD screen will appear for one second as unit performs a quick diagnosis. A voice tone will indicate when unit is ready for testing. 2. Pressurization The unit will automatically inflate to the proper pressure value and stop inflating. During this time,please keep quiet. mmHg kPa AVG
(( ))
/
No mmHg
/
Note: Pressurization will gradually subside and ultimately stop when cuff is not properly applied to the arm. If this occurs, press START/STOP button to turn the unit off. 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 17 Unit Operation 18 3. Testing After cuff inflation, air will slowly subside as indicated by the corresponding cuff pressure value. A flashing " " will appear simultaneously on screen signaling heart beat detection. mmHg
/
Note: Keep relaxed during testing. Avoid speaking or moving body parts. 4. Result Display 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. Indicator mmHg
/
Note: Refer to Page 23~24 for detail WHO Blood Pressure Classification Information. Irregular Heartbeat Indicator If the monitor detects an irregular heart rhythm two or more times during the measuring process, the Irregular Heartbeat Symbol " "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. 5. Deleting/Storing Test Results User may delete their current test result due to unfavorable testing conditions or for any other reason. To delete the last test result, press the "SET" button after result is displayed. If result is not deleted, it will automatically store by date within the previously configured Memory Group. Note: Be sure the appropriate Memory Group selection is made prior to testing. If the number of tests surpasses the allotted 60 memories per group, the most recent tests will appear first, thus eliminating the oldest readings. Power Off turn off the power itself about 3 minutes no operation in any mode. The " START/STOP " button can be pressed to turn off the unit in any mode. The unit can Safety Precaution: If pressure in arm cuff becomes too extreme while testing, press the " START/STOP " button to turn power off. The cuff pressure will rapidly dissipate once the unit is off. Unit Operation 19 Unit Operation 20 Last 3 Tests Average With power offpress the "M" 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 "AVG" symbol will appear along with the corresponding WHO Blood Pressure Indicator. The Memory Check mode can be accessed by pressing "M" buttons. To check the average results from other groups, select the desired group first prior to activating "SET" button in the off position.(See "Select Memory Group" on Page 10) Memory Check With power offyou may check past test results by using the "M" buttons. The most recent test result and oldest test result in memory can be viewed by pressing and holding the "M" button. Upon activating test results. you can press the "M"
button to scroll through all test results stored in memory. mmHg AVG
/
mmHg
/
No
/
NotePrevious test will only be displayed from the most recently used memory group . To check previous test results in other memory groups, you must first select the desired group and then turn monitor off.(See"Select Memory Group" on Page 10 ) Unit Operation Memory Deletion Memory for a selected group may be deleted while in Memory Check mode. Press and hold the " SET " button for approximately 3 seconds to delete all memory records from the selected groupwith voice broadcast "Memory Clear" and then transfer into testing mode. Press the "START/STOP " button to turn the unit off. 21 Unit Operation Static Pressure Measurement In the power down state, press and hold the " START/STOP" button, and theninstall the batteries. Until the LCD screen is full, release the " START/STOP" button. When the LCD screen displays the double zero, the bloodpressure meter is in static state. Software version is displayed at the heart rate . 22 Note: Memory cannot be recovered once it has been deleted. Low Battery Indicator The unit will broadcast "Low Battery" when battery life is depleting and unable to inflate cuff for testing. The " " appears simultaneously for approximately 5 seconds prior to shutting off. Replace batteries at this time. No memory loss will occur throughout this process. mmHg
/
Note: Only Service personnel permitted to access to this mode, the mode unavailable in normal use. Bluetooth requirements The monitor requires a device with:
. Bluetooth 4.0 or later
. Android 5.0 or later
. IOS 9.0 or later And works with:
. iphone , iPod, iPad
. Android Phones and Tablets Wireless communication Frequency range : 2.4 Ghz (2400-2483.5 MHz) Modulation : GFSK Antenna gain:0.5dBi Unit Operation Bluetooth connection Using for the first time 1. Download the free JOYTECH healthcare 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. Pairing your monitor with a Smart Device The date and time on your monitor will automatically be set when you pair it with your smart device. 1. Make sure the Bluetooth in your smart device is turned on. 2. Open the app on your smart device and follow the set-up and pairing instructions. 3. Confirm the monitor is connected successfully. 23 Unit Operation Troubleshooting 24 Problem Possible Cause Solution Cuff is too tight or not properly positioned on the arm Firmly reposition cuff approximately
(
above the elbow joint
( See Page 12) 1-2cm 1/2"
) Blood pressure results are not within typical range Inaccurate test results due to body movement or monitor movement Sit in a relaxed position with arm placed near heart. Avoid speaking or moving body parts while testing. Make sure the monitor unit is placed in a stationary position throughout the testing period.
( See Page 7) If the monitor is connected successfully to the smart device, bLE on will appear on the
" "displayed monitor display. mmHg
/
Connection failure./
Data is not being transmitted Cuff fails to inflate properly Make sure hose is properly fastened to cuff and monitor unit Improper operation Read user manual carefully and re-test properly. Pressurization is over cuff rated pressure 300mmHg The blood pressure monitor might not be porperly placed within the smart devices tranmission range and is too far from the smart device. Read user manual carefully and re-test properly. If there are no causes of data transmission interference found near the blood pressure monitor, move the blood pressure monitor within 16ft.(5m) of the smart device and try again The blood pressure did not pair successfully to the smart device Try to pair the devices once again. The application on the smart device is not ready. Check the application then try sending the data again. Blood Pressure Information 25 Blood Pressure Information 26 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. 200 150 100 50 g H m m Upper curve : systolic blood pre ssur e Lower curve: diastolic blood pressure 6 12 18 Time of day 24 Example: fluctuation within a day (male, 35 years old) WHO Blood Pressure Classification Indicator The DBP-1319b is equipped with a classification indicator based on established guidelines from the World Health Organization. The chart below (color coded on monitor unit) indicates test results. Severe Hypertension Moderate Hypertension Mild Hypertension High-n ormal Normal Optimal Mild Hypertension mmHg
/
:
Blood Pressure Classification Indicator Blood Pressure Information 27 Health Reminder Hypertension is a dangerous disease that can affect the quality of life. It can lead to a lot of problems including heart failure, kidney failure, and cerebral hemorrhaging. By maintaining a healthy lifestyle and visiting your physician on a regular basis, hypertension and relative diseases are much easier to control when diagnosed in their Blood Pressure QA 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. 28 early stages. Systolic
( mmHg ) 180 160 140 130 120 Severe Hypertension Moderate Hypertension Mild Hypertension High-normal Normal Optimal 80 85 90 100 110 Diastolic
( mmHg ) Note: Do not be alarmed if an abnormal reading occurs. blood pressure occurs after 2-3 readings are taken at the same time extended period of time. Consult your physician if test results remain abnormal. A better indication of an individual's each day over an Note: Abnormal test results may be caused by:
1. Improper cuff placement Make sure cuff is snug-not too tight or too loose. Make sure bottom of the cuff is approximately 1-2cm (1/2'') above the elbow joint. 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. 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 arm? What is the difference?
A: Either arm can be used when testing, however, when comparing results, the same arm should be used. Testing on your left arm 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. Maintenance 1. Avoid dropping, slamming, or throwing the unit. SET S A S T P T R O T M m P Hg m UL Hg m m DIA m S Y m Hg S 29 Maintenance 30 4. Cuff Cleaning and Disinfection:
A) Spread the cuff (skin-contact surface) upwards onto a clean table. Use a damp clean cloth
(water-based) to wipe the skin-contact surface with a force. B) Soak the cloth clean with drinking water and wring it dry. Repeat A) with the damp cloth
(water-based) for 3 times. C) Apply 70%-80% alcohol to a new cloth (or 75% alcohol cotton-ball), use it to wipe the skin-contact surface with a force. Then soak the cloth with the alcohol again
(or change a new 75% alcohol cotton-ball), repeat the disinfection procedure for 3 times. D)When the disinfection towards the skin-contactsurface is finished,wipe thenon-skin contact surface with a cloth (alcohol-based) or alcohol cotton-ball thoroughly for 3 times. E)Leave the cuff naturally dry,then it is ready for reuse. Notice: Do not soak in water or splash water on it. 2. Avoid extreme temperatures. Do not expose unit directly under sunshine. 5. Do not use petrol, thinners or similar solvents. SYS mmHg DIA mmHg PUL mmHg SET START STOP M 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. SYS mmHg DIA mmHg PUL mmHg SET START STOP M 6. Remove batteries when not in operation for an extended period of time. 7. Do not disassemble product. SYS mmHg DIA mmHg PUL mmHg SET START STOP M 8. It is recommended the performance should be checked every 2 years. 9. Expected service life: Approximately three years at 10 tests per day. 10.No service and maintenance while it is in use and maintenance only be performed by service personnel. Service and maintenance require parts, repair, technical support will be provided. Specifications 31 Specifications Product Description Arm-type Fully Automatic Blood Pressure Monitor Model Display DBP-1319b LCD Digital Display Size: 102mm 68.9mm (4.02" x 2.71" ) Measurement Method Oscillometric Method Systolic Pressure 60mmHg28 0mmHg Diastolic Pressure 30mmHg200mmHg Pressure Pressure 0mmHg300mmHg 3mmHg Measurement Range Pulse 30 ~ 180 Beats/Minute 5%
Pulse Automatic Pressurization 120 Memories in Two Groups with Date and Time Irregular Heartbeat Detection WHO Classification Indicator Last3 Tests Average Low Battery Detection Pressurization Memory Function Automatic Power-Off Backlight Voice Bluetooth 4 AA batteries or Medical AC Adapter(DC6.0V, 600mA)
(recommended, not provided) Approximately 2 months at 3 tests per day Approx.480g (16.93 oz.) (excluding battery) Approx.166 x 114 x 72mm (6.54" x 4.49" x 2.83" )(L x W x H) Power Source Battery Life Unit Weight Unit Dimensions Cuff Circumference Medium cuff: Fits arm circumference 22-36 cm Operating Environment Humidity Temperature 10 ~ 40 (50 ~104 ) 15% ~ 93% RH Pressure 700hPa~1060hPa Storage Environment Temperature:
Humidity 32
)
(-13 ~158
-25 ~70 93% RH Classification:
Internal Powered Equipment,Type BF . Cuff is the Applied Part Ingress Protection Rating:
IP20, Indoor Use Only Battery Shelf life:
60 months
-25~55 (-13~131) Battery Storage Temperature:
Specifications are subject to change without notice. 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. ANSI/AAMI ISO 81060-2, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type. (Cardiovascular) 3. AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)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. Correct Disposal of This Product
(Waste Electrical & Electronic Equipment) This marking shown on the product indicates that it should not be disposed with other household waste at the end of its life. To prevent potential harm to the environment or to human health, please separate this product from other types of wastes and recycle it responsibly. When disposing this type of product, contact the retailer where product was purchased or contact your local government office for details regarding how this item can be disposed in an environmentally safe recycling center. Business users should contact their supplier and check the terms and conditions of the purchasing agreement. This product should not be mixed with other commercial wastes for disposal. This product is free of hazardous materials. Warranty 33 Electromagnetic Compatibility Information 34 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 Pressure Monitor due to improper handling. Please contact local retailer for details. 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. 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. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Emissions test Compliance Radiated emission CISPR 11 Group 1, class B. Conducted emission CISPR 11 Group 1, class B. Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Class A Complies Electromagnetic Compatibility Information Table 2 35 Electromagnetic Compatibility Information 36 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 Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV,4 kV, 8 kV, 15 kV air 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 %. Electrostatic transient/burst IEC 61000-4-4 2 kV , 100kHz, for AC power port 2 kV , 100kHz, for AC power port Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 0.5kV, 1kV
(differential mode) 0.5kV, 1kV
(differential mode) Mains power quality should be that of a typical commercial or hospital environment. 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT;
250/300 cycle 0 % UT;
250/300 cycle Voltage dips, short interrupti-
ons and voltage variations on p-
ower supply in-
put lines IEC 61000-4-11 Mains power quality should be that of a typical commercial or hospital environment. 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. Table 3 Guidance and declaration of manufacturer-electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-
4-3 IEC 60601 test level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz Compliance level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz 385MHz, 27V
/m 385MHz, 27V
/m 450MHz, 28V
/m 450MHz, 28V
/m 710MHz,745 MHZ,780MHz 9V/m 710MHz,745 MHZ,780MHz 9V/m 810MHz,870 MHZ,930MHz 28V/m 810MHz,870 MHZ,930MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 2450MHz, 28V
/m 2450MHz, 28V
/m 5240MHz,5500 MHZ,5785MHz 9V/m 5240MHz,5500 MHZ,5785MHz 9V/m Electromagnetic environment
-guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended seperation distance 80 MHz to 800 MHz 800 MHz to 2.7 Ghz where P is 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:
37 Electromagnetic Compatibility Information Table 4 Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated therefore disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W 0.01 0.1 1 10 100 Separation distance according to frequency of transmitter m 800 MHz to 2.7 GHz 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 80 MHz to 800 MHz 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 th frequency range applies. e higher NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
1 | DBP1332b-FDA Manual | Users Manual | 1.39 MiB |
Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1332b Arm Type Document No.:JDBP-3704-050 VersionZ Date of Issue2018.12 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 1 Safety Notice 2 Thank you for purchasing the DBP-1332b Blood Pressure Monitor. The unit has been constructed using reliable circuitry and durable materials. Used properly, this unit will provide yeas of satisfactory use. Measure blood pressure(systolic and diastolic)and pulse rate of adults and adolecents age 12 through 21years of age. All functions can be used safely and functions can be used safely and values can be read out in one LCD DISPLAY. Measurement position is on adult upper arm 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 81060-2-30) 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 oC, 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 oC, 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. Contents Safety Notice ............................................................... 02 Unit Illustration ......................................................... 06 Important Testing Guidelines ..................................... 09 Quick Start ................................................................. 10 Unit Operation ........................................................... 11 Battery Installation .................................................. 11 System Settings ........................................................ 12 Applying the Arm Cuff ............................................. 14 Testing ..................................................................... 15 Power Off ................................................................ 18 Memory Check ........................................................ 19 Memory Deletion ..................................................... 20 Last 3 Tests Average ................................................. 21 Low Battery Indicator ............................................. 21 Bluetooth requirements ........................................... 23 Troubleshooting ...................................................... 22 Blood Pressure Information ........................................ 25 Blood Pressure Q A ................................................... 28 Maintenance ............................................................... 29 Specifications ............................................................. 31 Warranty .................................................................... 33 Electromagnetic Compatibility Information .............. 34 Safety Notice 3 Important Instructions Before Use 1. Do not confuse self-monitoring with self-diagnosis. Blood pressure measurements should only be interpreted by a health professional who is familiar with your medical history. 2. Contact your physician if test results regularly indicate abnormal readings. 3. If you are taking medication, consult with your physician to determine the most appropriate time to measure your blood pressure. NEVER change a prescribed medication without first consulting with your physician. 4. Individuals with serious circulation problems may experience discomfort. Consult your physician prior to use. 5. For persons with irregular or unstable circulation resulting from diabetes, liver disease, arteriosclerosis or other medical conditions, there may be variations in blood pressure values measured at the wrist versus at the upper arm. Monitoring the trends in your blood pressure taken at either the arm or the wrist is nevertheless useful and important. 6. People suffering from vascular constriction, liver disorders or diabetes, people with cardiac pacemakers or a weak pulse, and women who are pregnant should consult their physician before measuring their blood pressure themselves. Different values may be obtained due to their condition. 7. People suffering from arrhythmias such as atrial or ventricular premature beats or atrial fibrillation only use this blood pressure monitor in consultation with your doctor. In certain cases oscillometric measurement method can produce incorrect readings. 8.Too frequent measurements can cause injury to the patient due to blood flow interference. 9.The cuff should not be applied over a wound as this can cause further injury. 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 arm cuff. Do not attempt to repair. 19. Use only the approved arm cuff for this unit. Use of other arm cuffs may result in incorrect measurement results. 20. The system might produce incorrect readings if stored or used outside 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. 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. Safety Notice 4 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. Dispose batteries properly; observe local laws and regulations. 27. Only use a recommended AC adaptor double-insulated complying with EN 60601-1 and EN 60601-1-2. An unauthorized adapter may cause fire and electric shock. 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. Please align the polarities of each battery with the +ve and -ve signs imprinted on the battery housing when you replace the batteries . 32.This ME equipment or ME systems should be only used in shielded location. 33.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. 34.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 the unit, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. WARNING SIGNS AND SYMBOLS USED Keep Dry 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. Safety Notice Federla Commulcation Commission (FCC) Interference Statement 5 Unit Illustration 6 1.This device complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. 2.This device is verified to comply with part 15 of the FCC Rules for use with cable television service. 3.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. 4.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. Monitor Unit Blood Pressure Classification Indicator LCD SYS mmHg Systolic Blood Pressure Diastolic Blood Pressure DIA mmHg Pulse Rate PULSE
/min S TA R T S T O P M SET
" "
M Button START/STOP
"
"
Button
"
"
SET Button Air Jack Battery cover AC Adapter Jack Unit Illustration Arm Cuff Medium size cuff (fits arm circumference: 22.0 cm -36.0 cm). 7 Unit Illustration 8 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 0 . 4 c m (
2
~
1 M R T A F E L
) h c n 0 . 8 i
~
M a i n A r t y r e I N D X E Arm Cuff Air Plug Air Tube If air is leakingfrom the arm cuff, replace the arm cuff with a new one. It is generally recommended to have the cuff replaced timely to ensure correct functioning and accuracy. Please consult your local authorized distributor or dealer. Display Groups Low Battery Indicator WHO Blood Pressure Classification Indicator mmHg kPa Last 3 Results Average Irregular Heartbeat Indicator AVG
(( )) Time Date D No M Systolic Blood Pressure Diastolic Blood Pressure Pulse Rate Contents SYS mmHg DIA mmHg SET PULSE
/min S TA R T S T O P M 1.Monitor Unit 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 0 . 4 c m (
2
~
1 M R T A F E L
) h c n 0 . 8 i
~
M a i n A r t y r e I N D X E Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1332b Arm Type 2.Owner's Manual 4.Storage Bag 3.Arm Cuff 5.2MOPPMedical AC Adapter(DC6.0 V,600mA)
(recommended, not provided) Important Testing Guidelines 9 Quick Start 10 Avoid eating, exercising, and bathing for 30 minutes prior to testing. Sit in a calm environment for at least 5 minutes prior to testing. 1. 2. Do not stand while testing. Sit in a relaxed position while keeping your arm level with 3 your heart. 4. Avoid speaking or moving body parts while testing. 5. While testing, avoid strong electromagnetic interference such as microwave ovens and cell phones. 6
. Wait 3 minutes or longer before re-testing. Try to measure your blood pressure at the same time each day for consistency. 7 8
. Test comparisons should only be made when monitor is used on the same arm, 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. Any blood pressure recording can be affected by the following factors:
1. The position of the subject, his or her physiologic condition;
2. The performance and accuracy of the device;
3. Cuff size: too small cuff (bladder) will produce a higher blood pressure value than usual, too big cuff (bladder) will produce a lower blood pressure value;
4. Measuring position does not keep level with your heart;
5. Speaking or moving body parts while testing;
6. Not relaxing for about 5 minutes before taking the measurement. 1. Install batteries 2. Insert cuff air plug into the left side of monitor unit. (See Figure B)
. (See Figure A ) SYS mmHg DIA mmHg SET PULSE
/min S TA R T S T O P M Figure A Figure B 3. Remove thick clothing from the arm area. 4. Rest for several minutes prior to testing. Sit down in a quietplace comfortably , back and arm support on a desk or table ,with your legs uncrossed ,your arm resting on a firm and your feet flat on the floor. (See Figure C ) Figure C 5. Apply cuff to your left arm and middle of the cuff at the level of your heart. Bottom of cuff should be placed approximately 1-2cm ('') above elbow joint.(See Figures D&E) 1
-
2 c m
(
0.4
-
0.8
''
) Figure D Figure E 6. Press " START/STOP " Button to start testing. Unit Operation Battery Installation Slide battery cover off as indicated by arrow. Install 4 new AA alkaline batteries according to polarity. Close battery cover. 11 Unit Operation System Settings 12 With power off, press "SET" button to activate System Settings. The Memory Group icon flashes. 1. Select Memory Group While in the System Setting mode, you may accumulate test results into 2 different groups. This allows multiple users to save individual test results (up to 60 memories per group.) Press " M " button to choose a group setting. Test results will automatically store in each selected group. AC Adapter jack is on the back side of the monitor. Medical AC adapter(DC 6.0 V,600mA) can be used with the device (recommended, not provided). The adapter connect pin should be positive inside and negative outside with a 2.1mm coaxial joint. Do not use another type of AC adapter as it may harm the unit. 2. Time /Date Setting Press "SET" button again to set the Time/Date mode. Set the month first by adjusting the
" M " button. Press "SET " button again to confirm current month. Continue setting the day, hour and minute in the same way. Every time the " SET " button is pressed, it will lock in your selection and continue in succession (month, day, hour, minute.) AC Adapter Jack Note:Power supply is specified as part of ME EQUIPMENT. M D Unit Operation 13 Unit Operation 14 3.Voice Setting Press "SET" button to enter voice setting mode. Set voice format ON or OFF by pressing the "M" button. Applying the Arm Cuff 1. Firmly insert air plug into opening located on left side of monitor unit. 4.Volume Setting Press "SET" button to enter volume setting mode. Set the voice volume by adjusting the "M" button . There are six volume levels. 5. Saved Settings While in any setting mode, press " START/STOP " button to turn the unit off. All information will be saved. SYS mmHg DIA mmHg SET PULSE
/min S TA R T S T O P M 2. With sticky nylon section facing outward, insert end of cuff underneath metal ring
. of cuff 3. Fasten cuff about 1-2cm (0.4-0.8'') above the elbow joint. For best results apply cuff to bare arm and keep level with heart while testing
. 1
-
2 c m
(
0.4
-
0.8
''
) Note: If unit is left on and not in use for 3 minutes, it will automatically save all information and shut off. Note: Do not insert air plug into opening located on right side of monitor unit. This opening is designed for an optional power supply only. Unit Operation 15 Unit Operation 16 Testing 1. Power On Press and hold "START/STOP" button to turn the unit on. The LCD screen will appear for one second as unit performs a quick diagnosis. A voice tone will indicate when unit is ready for testing. mmHg kPa AVG
(( )) D No M Note: Unit will not function if residual air from previous testing is present in cuff. The LCD will flash " " until pressure is stabilized. 2. Pressurization The unit will automatically inflate to the proper pressure value and stop inflating. During this time,please keep quiet. mmHg M D Note: Pressurization will gradually subside and ultimately stop when cuff is not properly applied to the arm. If this occurs, press START/STOP button to turn the unit off. Unit Operation 17 Unit Operation 18 3. Testing After cuff inflation, air will slowly subside as indicated by the corresponding cuff pressure value. A flashing " " will appear simultaneously on screen signaling heart beat detection. mmHg M D Note: Keep relaxed during testing. Avoid speaking or moving body parts. 4. Result Display 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. Indicator mmHg M D Note: Refer to Page 23~24 for detail WHO Blood Pressure Classification Information. Irregular Heartbeat Indicator If the monitor detects an irregular heart rhythm two or more times during the measuring process, the Irregular Heartbeat Symbol " "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. 5. Deleting/Storing Test Results User may delete their current test result due to unfavorable testing conditions or for any other reason. To delete the last test result, press the "SET" button after result is displayed. If result is not deleted, it will automatically store by date within the previously configured Memory Group. Note: Be sure the appropriate Memory Group selection is made prior to testing. If the number of tests surpasses the allotted 60 memories per group, the most recent tests will appear first, thus eliminating the oldest readings. Power Off turn off the power itself about 3 minutes no operation in any mode. The " START/STOP " button can be pressed to turn off the unit in any mode. The unit can Safety Precaution: If pressure in arm cuff becomes too extreme while testing, press the " START/STOP " button to turn power off. The cuff pressure will rapidly dissipate once the unit is off. Unit Operation Memory Check With power off, you may check past test results by using the " M " button. The most recent test result and oldest test result in memory can be viewed by pressing and holding the " M " button upon activating test results you can press the M button to scroll through all test results stored in memory. 19 Unit Operation Memory Deletion 20 Memory for a selected group may be deleted while in Memory Check mode. Press and hold the " SET " button for approximately 3 seconds to delete all memory records from the selected groupwith voice broadcast "Memory Clear" and then transfer into testing mode. Press the "START/STOP " button to turn the unit off. mmHg D No M M D Note: Previous test results will only be displayed from the most recently used memory group. To check previous test results in other memory groups, you must first select the desired group and then turn monitor off.
(See "Select Memory Group" on Page 10.) Note: Memory cannot be recovered once it has been deleted. Unit Operation Last 3 Tests Average With power off, press the " M " 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. The Memory Check mode can be accessed by pressing the "M " button. To check the average results from other groups, select the desired group first prior to activating the " M " button in the off position. (See "Select Memory Group" on Page 10.) mmHg AVG Low Battery Indicator The unit will broadcast "Low Battery" when battery life is depleting and unable to inflate cuff for M D testing. The " " appears simultaneously for approximately 5 seconds prior to shutting off. Replace batteries at this time. No memory loss will occur throughout this process. 21 Unit Operation Static Pressure Measurement In the power down state, press and hold the " START/STOP" button, and theninstall the batteries. Until the LCD screen is full, release the " START/STOP" button. When the LCD screen displays the double zero, the bloodpressure meter is in static state. Software version is displayed at the heart rate . 22 mmHg
/
Note: Only Service personnel permitted to access to this mode, the mode unavailable in normal use. Bluetooth requirements The monitor requires a device with:
. Bluetooth 4.0 or later
. Android 5.0 or later
. IOS 9.0 or later And works with:
. iphone , iPod, iPad
. Android Phones and Tablets Wireless communication Frequency range : 2.4 Ghz (2400-2483.5 MHz) Modulation : GFSK Antenna gain:0.5dBi Unit Operation 23 Unit Operation Troubleshooting 24 Bluetooth connection Using for the first time 1. Download the free JOYTECH healthcare App: On your mobile phone or table go to www.sejoy.com. Problem Possible Cause Solution Cuff is too tight or not properly positioned on the arm Firmly reposition cuff approximately
(
above the elbow joint
( See Page 12) 1-2cm 1/2"
) 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. Blood pressure results are not within typical range 4. Selection device Blood pressure monitor. Pairing your monitor with a Smart Device The date and time on your monitor will automatically be set when you pair it with your smart device. 1. Make sure the Bluetooth in your smart device is turned on. 2. Open the app on your smart device and follow the set-up and pairing instructions. 3. Confirm the monitor is connected successfully. If the monitor is connected successfully to the smart device, bLE on will appear on the monitor display. mmHg
/
Inaccurate test results due to body movement or monitor movement Sit in a relaxed position with arm placed near heart. Avoid speaking or moving body parts while testing. Make sure the monitor unit is placed in a stationary position throughout the testing period.
( See Page 7) Cuff fails to inflate properly Make sure hose is properly fastened to cuff and monitor unit Improper operation Read user manual carefully and re-test properly.
" "displayed Connection failure./
Data is not being transmitted Pressurization is over cuff rated pressure 300mmHg The blood pressure monitor might not be porperly placed within the smart devices tranmission range and is too far from the smart device. Read user manual carefully and re-test properly. If there are no causes of data transmission interference found near the blood pressure monitor, move the blood pressure monitor within 16ft.(5m) of the smart device and try again The blood pressure did not pair successfully to the smart device Try to pair the devices once again. The application on the smart device is not ready. Check the application then try sending the data again. Blood Pressure Information 25 Blood Pressure Information 26 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 200 150 100 50 g H m m 6 12 18 Time of day 24 Example: fluctuation within a day (male, 35 years old) WHO Blood Pressure Classification Indicator The DBP-1332b is equipped with a classification indicator based on established guidelines from the World Health Organization. The chart below (color coded on monitor unit) indicates test results. Severe Hypertension Moderate Hypertension Mild Hypertension High-n ormal Normal Optimal Mild Hypertension mmHg M D
:
Blood Pressure Classification Indicator Blood Pressure Information 27 Blood Pressure QA 28 Health Reminder Hypertension is a dangerous disease that can affect the quality of life. It can lead to a lot of problems including heart failure, kidney failure, and cerebral hemorrhaging. By maintaining a healthy lifestyle and visiting your physician on a regular basis, hypertension and relative diseases are much easier to control when diagnosed in their early stages. Systolic
( mmHg ) 180 160 140 130 120 Severe Hypertension Moderate Hypertension Mild Hypertension High-normal Normal Optimal 80 85 90 100 110 Diastolic
( mmHg ) Note: Do not be alarmed if an abnormal reading occurs. blood pressure occurs after 2-3 readings are taken at the same time extended period of time. Consult your physician if test results remain abnormal. A better indication of an individual's each day over an 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. Make sure bottom of the cuff is approximately 1-2cm (1/2'') above the elbow joint. 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. 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 arm? What is the difference?
A: Either arm can be used when testing, however, when comparing results, the same arm should be used. Testing on your left arm 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. Maintenance 29 Maintenance 30 1. Avoid dropping, slamming, or throwing the unit. E in
/
m S L U P g H m m A I D g H S m Y m S M P T O R T A S T S T E S 4. Cuff Cleaning and Disinfection:
A) Spread the cuff (skin-contact surface) upwards onto a clean table. Use a damp clean cloth
(water-based) to wipe the skin-contact surface with a force. B) Soak the cloth clean with drinking water and wring it dry. Repeat A) with the damp cloth
(water-based) for 3 times. C) Apply 70%-80% alcohol to a new cloth (or 75% alcohol cotton-ball), use it to wipe the skin-contact surface with a force. Then soak the cloth with the alcohol again
(or change a new 75% alcohol cotton-ball), repeat the disinfection procedure for 3 times. D)When the disinfection towards the skin-contactsurface is finished,wipe thenon-skin contact surface with a cloth (alcohol-based) or alcohol cotton-ball thoroughly for 3 times. E)Leave the cuff naturally dry,then it is ready for reuse. Notice: Do not soak in water or splash water on it. 2. Avoid extreme temperatures. Do not expose unit directly under sunshine. 5. Do not use petrol, thinners or similar solvents. SYS mmHg DIA mmHg SET PULSE
/min S TA R T S T O P M 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. SYS mmHg DIA mmHg SET PULSE
/min S TA R T S T O P M 6. Remove batteries when not in operation for an extended period of time. 7. Do not disassemble product. SYS mmHg DIA mmHg SET PULSE
/min S TA R T S T O P M 8. It is recommended the performance should be checked every 2 years. 9. Expected service life: Approximately three years at 10 tests per day. 10.No service and maintenance while it is in use and maintenance only be performed by service personnel. Service and maintenance require parts, repair, technical support will be provided. Specifications 31 Specifications Product Description Arm-type Fully Automatic Blood Pressure Monitor Model Display DBP-1332b LCD Digital Display Size: 84.1mm 55.1mm (3.31" x 2.17" ) Measurement Method Oscillometric Method Systolic Pressure 60mmHg28 0mmHg Diastolic Pressure 30mmHg200mmHg Measurement Range Pressure Pressure 0mmHg300mmHg 3mmHg or 2% above 200mmHg Pulse 30 ~ 180 Beats/Minute Pressurization Memory Pulse Automatic Pressurization 5%
120 Memories in Two Groups with Date and Time Irregular Heartbeat Detection WHO Classification Indicator Last 3 Results Average Low Battery Detection Automatic Power-Off Backlight Voice Bluetooth 4 AA batteries or Medical AC Adapter(DC6.0V, 600mA)
(recommended, not provided) Approximately 2 months at 3 tests per day Approx.382g (13.47 oz.) (excluding battery) Function Power Source Battery Life Unit Weight Unit Dimensions Approx.148x100x56mm (5.83"x3.94"x2.21")LxWxH Cuff Circumference Medium cuff: Fits arm circumference 22-36 cm Temperature 10 ~ 40 (50 ~104 ) Operating Environment Humidity Pressure 15%93%RH 700hPa~1060hPa Warranty 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 Pressure Monitor due to improper handling. Please contact local retailer for details. Storage Environment Temperature:
Humidity 32
)
(-13 ~158
-25 ~70 93% RH Classification:
Ingress Protection Rating:
Internal Powered Equipment,Type BF . Cuff is the Applied Part IP20, Indoor Use Only 60 months
-25~55 (-13~131) Battery Shelf life:
Battery Storage Temperature:
Specifications are subject to change without notice. 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. ANSI/AAMI ISO 81060-2, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type. (Cardiovascular) 3. AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)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. 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. 33 Electromagnetic Compatibility Information 34 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. 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. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Emissions test Compliance Radiated emission CISPR 11 Group 1, class B. Conducted emission CISPR 11 Group 1, class B. Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Class A Complies Warranty Table 2 35 Electromagnetic Compatibility Information 36 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 Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV,4 kV, 8 kV, 15 kV air 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 %. Electrostatic transient/burst IEC 61000-4-4 2 kV , 100kHz, for AC power port 2 kV , 100kHz, for AC power port Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 0.5kV, 1kV
(differential mode) 0.5kV, 1kV
(differential mode) Mains power quality should be that of a typical commercial or hospital environment. 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT;
250/300 cycle 0 % UT;
250/300 cycle Voltage dips, short interrupti-
ons and voltage variations on p-
ower supply in-
put lines IEC 61000-4-11 Mains power quality should be that of a typical commercial or hospital environment. 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. Table 3 Guidance and declaration of manufacturer-electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-
4-3 IEC 60601 test level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz Compliance level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz 385MHz, 27V
/m 385MHz, 27V
/m 450MHz, 28V
/m 450MHz, 28V
/m 710MHz,745 MHZ,780MHz 9V/m 710MHz,745 MHZ,780MHz 9V/m 810MHz,870 MHZ,930MHz 28V/m 810MHz,870 MHZ,930MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 2450MHz, 28V
/m 2450MHz, 28V
/m 5240MHz,5500 MHZ,5785MHz 9V/m 5240MHz,5500 MHZ,5785MHz 9V/m Electromagnetic environment
-guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended seperation distance 80 MHz to 800 MHz 800 MHz to 2.7 Ghz where P is the maximum output power rating of the transmitter in watts (W) according to the transm-
itter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:
Electromagnetic Compatibility Information 37 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 W 0.01 0.1 1 10 100 Separation distance according to frequency of transmitter m 800 MHz to 2.7 GHz 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 80 MHz to 800 MHz 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 th frequency range applies. e higher NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
1 | DBP1333b-FDA Manual | Users Manual | 1.13 MiB |
Document No.:JDBP-3804-050 Version: Z Date of Issue: 2018.12 Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1333b Arm Type 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 Safety Notice ............................................................... 02
......................................................... 0 6 Unit Illustration
..................................... 0 Important Testing Guidelines 9 Quick Start ................................................................. 10 Unit Operation ........................................................... 1 1 Battery Installation .................................................. 11 System Settings ........................................................ 12 Applying the Arm Cuff ............................................. 14 Testing ..................................................................... 15 Power Off ................................................................ 18
.......... ...................................... 19 Memory Check ...................................................... 20 Memory Deletion ..................................................... 21 Low Battery Indicator ............................................. 21 Bluetooth requirements ........................................... 23 Troubleshooting ...................................................... 24
........................................ 2 Blood Pressure Information 5
................................................... 2 8 Blood Pressure QA
............................................................... 2 Maintenance 9
............................................................. Specifications 31 Warranty .................................................................... 3 3 Electromagnetic Compatibility Information .............. 3 4 Last 3 Tests Average 1 Safety Notice 2 Thank you for purchasing the DBP-1333b Blood Pressure Monitor. The unit has been constructed using reliable circuitry and durable materials. Used properly, this unit will provide yeas of satisfactory use. Measure blood pressure(systolic and diastolic)and pulse rate of adults and adolecents age 12 through 21years of age. All functions can be used safely and values can be read out in one LCD DISPLAY. Measurement position is on adult upper arm 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 81060-2-30) 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 oC, 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 oC, 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. Safety Notice 3 Important Instructions Before Use 1. Do not confuse self-monitoring with self-diagnosis. Blood pressure measurements should only be interpreted by a health professional who is familiar with your medical history. 2. Contact your physician if test results regularly indicate abnormal readings. 3. If you are taking medication, consult with your physician to determine the most appropriate time to measure your blood pressure. NEVER change a prescribed medication without first consulting with your physician. 4. Individuals with serious circulation problems may experience discomfort. Consult your physician prior to use. 5. For persons with irregular or unstable circulation resulting from diabetes, liver disease, arteriosclerosis or other medical conditions, there may be variations in blood pressure values measured at the wrist versus at the upper arm. Monitoring the trends in your blood pressure taken at either the arm or the wrist is nevertheless useful and important. 6. People suffering from vascular constriction, liver disorders or diabetes, people with cardiac pacemakers or a weak pulse, and women who are pregnant should consult their physician before measuring their blood pressure themselves. Different values may be obtained due to their condition. 7. People suffering from arrhythmias such as atrial or ventricular premature beats or atrial fibrillation only use this blood pressure monitor in consultation with your doctor. In certain cases oscillometric measurement method can produce incorrect readings. 8.Too frequent measurements can cause injury to the patient due to blood flow interference. 9.The cuff should not be applied over a wound as this can cause further injury. 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 arm cuff. Do not attempt to repair. 19. Use only the approved arm cuff for this unit. Use of other arm cuffs may result in incorrect measurement results. 20. The system might produce incorrect readings if stored or used outside 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. 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. Safety Notice 4 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. Dispose batteries properly; observe local laws and regulations. 27. Only use a recommended AC adaptor double-insulated complying with EN 60601-1 and EN 60601-1-2. An unauthorized adapter may cause fire and electric shock. 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. Please align the polarities of each battery with the +ve and -ve signs imprinted on the battery housing when you replace the batteries . 32.This ME equipment or ME systems should be only used in shielded location. 33.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. 34.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 the unit, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. WARNING SIGNS AND SYMBOLS USED Keep Dry 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. Safety Notice Federla Commulcation Commission (FCC) Interference Statement 5 Unit Illustration 6 1.This device complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. 2.This device is verified to comply with part 15 of the FCC Rules for use with cable television service. 3.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. 4.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. Monitor Unit Blood Pressure Classification Indicator LCD SYS mmHg Systolic Blood Pressure Diastolic Blood Pressure DIA mmHg Pulse Rate PULSE
/min S TA R T S T O P M SET
" "
M Button START/STOP
"
"
Button
"
"
SET Button Air Jack Battery cover AC Adapter Jack Unit Illustration 7 Unit Illustration 8 Arm Cuff Medium size cuff (fits arm circumference: 22.0 cm -36.0 cm). Contents 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 4
. 0 c m (
2
~
1 M R T A F E L
) h c 8 i n
. 0
~
M a i n A r t y r e I N D X E Arm Cuff Air Plug Air Tube If air is leaking from the arm cuff, replace the arm cuff with a new one. It is generally recommended to have the cuff replaced timely to ensure correct functioning and accuracy. Please consult your local authorized distributor or dealer. Display Groups Low Battery Indicator WHO Blood Pressure Classification Indicator Results Average in Three Way Irregular Heartbeat Indicator Time Date mmHg kPa AVG
(( ))
/
No Systolic Blood Pressure Diastolic Blood Pressure Pulse Rate SYS mmHg DIA mmHg SET PULSE
/min S TA R T S T O P M 1.Monitor Unit M R T A F E L
) h c n 0 . 8 i
~
M a i n A r t y r e I N D X E Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1333b Arm Type 2.Owner's Manual 4.Storage Bag 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 0 . 4 c m (
2
~
1 3.Arm Cuff 5.2MOPPMedical AC Adapterr(DC6.0 V,600mA)
(recommended, not provided) Important Testing Guidelines 9 Quick Start 10 Avoid eating, exercising, and bathing for 30 minutes prior to testing. 1. 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 arm level with your heart. 4. Avoid speaking or moving body parts while testing. 5. While testing, avoid strong electromagnetic interference such as microwave ovens and cell phones. 6. Wait 3 minutes or longer before re-testing. 7. Try to measure your blood pressure at the same time each day for consistency. 8. Test comparisons should only be made when monitor is used on the same arm, 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.
:
Any blood pressure recording can be affected by the following factors 1. The position of the subject, his or her physiologic condition;
2. The performance and accuracy of the device;
3. Cuff size: too small cuff (bladder) will produce a higher blood pressure value than usual, too big cuff (bladder) will produce a lower blood pressure value;
4. Measuring position does not keep level with your heart;
5. Speaking or moving body parts while testing;
6. Not relaxing for about 5 minutes before taking the measurement. 1. Install batteries 2. Insert cuff air plug into the left side of monitor unit. (See Figure B)
. (See Figure A ) SYS mmHg DIA mmHg SET PULSE
/min S TA R T S T O P M Figure A Figure B 3. Remove thick clothing from the arm area. 4. Rest for several minutes prior to testing. Sit down in a quietplace comfortably , back and arm support on a desk or table ,with your legs uncrossed ,your arm resting on a firm and your feet flat on the floor. (See Figure C ) Figure C 5. Apply cuff to your left arm and middle of the cuff at the level of your heart. Bottom of cuff should be placed approximately 1-2cm ('') above elbow joint.(See Figures D&E) 1
-
2 c m
(
0.4
-
0.8
''
) Figure D Figure E 6. Press
" START/STOP "
Button to start testing. Unit Illustration Battery Installation Slide battery cover off as indicated by arrow. Install 4 new AA alkaline batteries according to polarity. Close battery cover. 11 Important Testing Guidelines 12 System Settings With power off, press "SET" button to activate System Settings. The Memory Group icon flashes. 1. Select Memory Group While in the System Setting mode, you may accumulate test results into 2 different groups. This allows multiple users to save individual test results (up to 60 memories per group.) Press " M " button to choose a group setting. Test results will automatically store in each selected group. AC Adapter jack is on the back side of the monitor. Medical AC adapter(DC 6.0 V,600mA) can be used with the device (recommended, not provided). The adapter connect pin should be positive inside and negtive outside with a 2.1mm coaxial joint. Do not use any other type of AC adapter as it may harm the unit. 2. Time/Date setting PressSET button again to set the Time/Date mode. Set the year first by adjusting the M button. PressSET button again to confirm current month. Continue setting the date, hour and minute in the same way. Every time the SET button is pressed, it will lock in your selection and continue in succession ( month,date,hour, minute) AC Adapter Jack Note:Power supply is specified as part of ME EQUIPMENT.
/
Unit Operation 3. Time Format setting Press SET button again to set the time fornat setting mode.Set the time format by adjusting theM button. EU means European Time US means U.S Time. 13 Unit Operation Applying the Arm Cuff 1. Firmly insert air plug into opening located on left side of monitor unit. 14
/
/
4.Voice Setting Press "SET" button to enter voice setting mode. Set voice format ON or OFF by pressing the "M" button. SYS mmHg DIA mmHg SET PULSE
/min S TA R T S T O P M 2. With sticky nylon section facing outward, insert end of cuff underneath metal ring of cuff
. 3. Fasten cuff about 1-2cm (0.4-0.8'') above the elbow joint. For best results apply cuff to bare arm and keep level with heart while testing
. 5.Volume Setting Press "SET" button to enter volume setting mode. Set the voice volume by adjusting the "M" button . There are six volume levels. 1
-
2 c m
(
0.4
-
0.8
''
) 6. Saved Settings While in any setting mode, press " START/STOP " button to turn the unit off. All information will be saved. Note: If unit is left on and not in use for 3 minutes, it will automatically save all information and shut off. Note: Do not insert air plug into opening located in the front of monitor unit. This opening is designed for an optional power supply only. Unit Operation 15 Unit Operation 16 Testing 1. Power On for one second as unit performs a quick diagnosis. A voice tone will indicate when unit is ready for testing. Press and hold "START/STOP" button to turn the unit on. The LCD screen will appear mmHg kPa AVG
(( ))
/
No Note: Unit will not function if residual air from previous testing is present in cuff. The LCD will flash " " until pressure is stabilized. 2. Pressurization The unit will automatically inflate to the proper pressure value and stop inflating. During this time,please keep quiet. mmHg
/
Note: Pressurization will gradually subside and ultimately stop when cuff is not properly applied to the arm. If this occurs, press START/STOP button to turn the unit off. Unit Operation 17 Unit Operation 18 3. Testing After cuff inflation, air will slowly subside as indicated by the corresponding cuff pressure value. A flashing " " will appear simultaneously on screen signaling heart beat detection. mmHg
/
Note: Keep relaxed during testing. Avoid speaking or moving body parts. 4. Result Display 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. Indicator mmHg
/
Note: Refer to Page 23~24 for detail WHO Blood Pressure Classification Information. Irregular Heartbeat Indicator If the monitor detects an irregular heart rhythm two or more times during the measuring process, the Irregular Heartbeat Symbol " "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. 5. Deleting/Storing Test Results User may delete their current test result due to unfavorable testing conditions or for any other reason. To delete the last test result, press the "SET" button after result is displayed. If result is not deleted, it will automatically store by date within the previously configured Memory Group. Note: Be sure the appropriate Memory Group selection is made prior to testing. If the number of tests surpasses the allotted 60 memories per group, the most recent tests will appear first, thus eliminating the oldest readings. Power Off turn off the power itself about 3 minutes no operation in any mode. The " START/STOP " button can be pressed to turn off the unit in any mode. The unit can Safety Precaution: If pressure in arm cuff becomes too extreme while testing, press the " START/STOP " button to turn power off. The cuff pressure will rapidly dissipate once the unit is off. Unit Operation 19 Unit Operation 20 Last 3 Tests Average With power offpress the "M" 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 "AVG" symbol will appear along with the corresponding WHO Blood Pressure Indicator. The Memory Check mode can be accessed by pressing "M" button. To check the average results from other groups, select the desired group first prior to activating "SET" button in the off position.(See "Select Memory Group" on Page 10) Memory Check With power offyou may check past test results by using the "M" button. The most recent test result and oldest test result in memory can be viewed by pressing and holding the "M" button. Upon activating test results. you can press the "M"
button to scroll through all test results stored in memory. mmHg AVG
/
mmHg
/
No
/
NotePrevious test will only be displayed from the most recently used memory group . To check previous test results in other memory groups, you must first select the desired group and then turn monitor off.(See"Select Memory Group" on Page 10 ) Unit Operation 21 Memory Deletion Memory for a selected group may be deleted while in Memory Check mode. Press and hold the " SET " button for approximately 3 seconds to delete all memory records from the selected groupwith voice broadcast "Memory Clear" and then transfer into testing mode. Press the "START/STOP " button to turn the unit off. Unit Operation Static Pressure Measurement In the power down state, press and hold the " START/STOP" button, and theninstall the batteries. Until the LCD screen is full, release the " START/STOP" button. When the LCD screen displays the double zero, the bloodpressure meter is in static state. Software version is displayed at the heart rate . 22 Note: Memory cannot be recovered once it has been deleted. Low Battery Indicator 4 short warning beeps sound when battery life is depleting and unable to inflate cuff for testing. The " " appears simultaneously for approximately 5 seconds prior to shutting off. Replace batteries at this time. No memory loss will occur throughout this process. mmHg
/
Note: Only Service personnel permitted to access to this mode, the mode unavailable in normal use. Bluetooth requirements The monitor requires a device with:
. Bluetooth 4.0 or later
. Android 5.0 or later
. IOS 9.0 or later And works with:
. iphone , iPod, iPad
. Android Phones and Tablets Wireless communication Frequency range : 2.4 Ghz (2400-2483.5 MHz) Modulation : GFSK Antenna gain:0.5dBi Unit Operation Bluetooth connection Using for the first time 1. Download the free JOYTECH healthcare 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. Pairing your monitor with a Smart Device The date and time on your monitor will automatically be set when you pair it with your smart device. 1. Make sure the Bluetooth in your smart device is turned on. 2. Open the app on your smart device and follow the set-up and pairing instructions. 3. Confirm the monitor is connected successfully. 23 Unit Operation Troubleshooting 24 Problem Possible Cause Solution Cuff is too tight or not properly positioned on the arm Firmly reposition cuff approximately
(
above the elbow joint
( See Page 12) 1-2cm 1/2"
) Blood pressure results are not within typical range Inaccurate test results due to body movement or monitor movement Sit in a relaxed position with arm placed near heart. Avoid speaking or moving body parts while testing. Make sure the monitor unit is placed in a stationary position throughout the testing period.
( See Page 7) If the monitor is connected successfully to the smart device, bLE on will appear on the
" "displayed monitor display. mmHg
/
Connection failure./
Data is not being transmitted Cuff fails to inflate properly Make sure hose is properly fastened to cuff and monitor unit Improper operation Read user manual carefully and re-test properly. Pressurization is over cuff rated pressure 300mmHg The blood pressure monitor might not be porperly placed within the smart devices tranmission range and is too far from the smart device. Read user manual carefully and re-test properly. If there are no causes of data transmission interference found near the blood pressure monitor, move the blood pressure monitor within 16ft.(5m) of the smart device and try again The blood pressure did not pair successfully to the smart device Try to pair the devices once again. The application on the smart device is not ready. Check the application then try sending the data again. Blood Pressure Information 25 Blood Pressure Information 26 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 200 150 100 50 g H m m 6 12 18 Time of day 24 Example: fluctuation within a day (male, 35 years old) WHO Blood Pressure Classification Indicator The DBP-1333b is equipped with a classification indicator based on established guidelines from the World Health Organization. The chart below (color coded on monitor unit) indicates test results. Severe Hypertension Moderate Hypertension Mild Hypertension High-n ormal Normal Optimal Mild Hypertension mmHg
/
:
Blood Pressure Classification Indicator Blood Pressure Information 27 Blood Pressure QA 28 Health Reminder Hypertension is a dangerous disease that can affect the quality of life. It can lead to a lot of problems including heart failure, kidney failure, and cerebral hemorrhaging. By maintaining a healthy lifestyle and visiting your physician on a regular basis, hypertension and relative diseases are much easier to control when diagnosed in their 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. early stages. Systolic
( mmHg ) 180 160 140 130 120 Severe Hypertension Moderate Hypertension Mild Hypertension High-normal Normal Optimal 80 85 90 100 110 Diastolic
( mmHg ) Note: Do not be alarmed if an abnormal reading occurs. blood pressure occurs after 2-3 readings are taken at the same time extended period of time. Consult your physician if test results remain abnormal. A better indication of an individual's each day over an Note: Abnormal test results may be caused by:
1. Improper cuff placement Make sure cuff is snug-not too tight or too loose. Make sure bottom of the cuff is approximately 1-2cm (1/2'') above the elbow joint. 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. 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 arm? What is the difference?
A: Either arm can be used when testing, however, when comparing results, the same arm should be used. Testing on your left arm 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. Maintenance 29 Maintenance 30 1. Avoid dropping, slamming, or throwing the unit. E in
/
m S L U P g H m m A I D M P T O R T A S T S T E S g H S m Y m S 2. Avoid extreme temperatures. Do not expose unit directly under sunshine. SYS mmHg DIA mmHg SET PULSE
/min S TA R T S T O P M 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. SYS mmHg DIA mmHg SET PULSE
/min S TA R T S T O P M 4. Cuff Cleaning and Disinfection:
A) Spread the cuff (skin-contact surface) upwards onto a clean table. Use a damp clean cloth
(water-based) to wipe the skin-contact surface with a force. B) Soak the cloth clean with drinking water and wring it dry. Repeat A) with the damp cloth
(water-based) for 3 times. C) Apply 70%-80% alcohol to a new cloth (or 75% alcohol cotton-ball), use it to wipe the skin-contact surface with a force. Then soak the cloth with the alcohol again
(or change a new 75% alcohol cotton-ball), repeat the disinfection procedure for 3 times. D)When the disinfection towards the skin-contactsurface is finished,wipe thenon-skin contact surface with a cloth (alcohol-based) or alcohol cotton-ball thoroughly for 3 times. E)Leave the cuff naturally dry,then it is ready for reuse. Notice: Do not soak in water or splash water on it. 5. Do not use petrol, thinners or similar solvents. 6. Remove batteries when not in operation for an extended period of time. 7. Do not disassemble product. SYS mmHg DIA mmHg SET PULSE
/min S TA R T S T O P M 8. It is recommended the performance should be checked every 2 years. 9. Expected service life: Approximately three years at 10 tests per day. 10.No service and maintenance while it is in use and maintenance only be performed by service personnel. Service and maintenance require parts, repair, technical support will be provided. Specifications 31 Specifications 32 Product Description Arm-type Fully Automatic Blood Pressure Monitor Model Display DBP-1333b LCD Digital Display Size:102.1mm68.9mm (4.02" x 2.71") Measurement Method Oscillometric Method Systolic Pressure 60mmHg28 0mmHg Diastolic Pressure 30mmHg200mmHg Measurement Range Pressure Pressure 0mmHg300mmHg 3mmHg or 2% above 200mmHg Pulse 30 ~ 180 Beats/Minute Pressurization Memory Function Power Source Battery Life Unit Weight Pulse Automatic Pressurization 5%
120 Memories in Two Groups with Date and Time Irregular Heartbeat Detection WHO Classification Indicator Last 3 Test Average Low Battery Detection Automatic Power-Off Backlight Voice Bluetooth 4 AA batteries or Medical AC Aadapter (DC6.0V, 600mA)
(recommended, not provided) Approximately 2 m onths at 3 tests per day Approx.430g (15.17 oz.) (excluding battery) Unit Dimensions Approx.164 x 111x 60mm (6.46" x 4.37" x 2.36" )(L x W x H) Cuff Circumference Medium cuff: Fits arm circumference 22-36 cm Temperature 10
~ 40 (50 ~104 ) Operating Environment Humidity Pressure 15% ~ 93%RH 700hPa~1060hPa Warranty 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 Pressure Monitor due to improper handling. Please contact local retailer for details. Temperature:
-25 ~70
(-13 ~158
) Storage Environment Humidity 93% RH Classification:
Ingress Protection Rating:
Battery Shelf life:
Battery Storage Temperature:
Internal Powered Equipment,Type BF . Cuff is the Applied Part IP20, Indoor Use Only 60 months
-25~55 (-13~131) Specifications are subject to change without notice. 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. ANSI/AAMI ISO 81060-2, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type. (Cardiovascular) 3. AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)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. 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. 33 Electromagnetic Compatibility Information 34 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. 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. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Emissions test Compliance Radiated emission CISPR 11 Group 1, class B. Conducted emission CISPR 11 Group 1, class B. Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Class A Complies Electromagnetic Compatibility Information Table 2 Guidance and declaration of manufacturer-electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environm-
ent. IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment
-guidance Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV,4 kV, 8 kV, 15 kV air 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 %. Electrostatic transient/burst IEC 61000-4-4 2 kV , 100kHz, for AC power port 2 kV , 100kHz, for AC power port Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 0.5kV, 1kV
(differential mode) 0.5kV, 1kV
(differential mode) Mains power quality should be that of a typical commercial or hospital environment. 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT;
250/300 cycle 0 % UT;
250/300 cycle Voltage dips, short interrupti-
ons and voltage variations on p-
ower supply in-
put lines IEC 61000-4-11 Mains power quality should be that of a typical commercial or hospital environment. 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. 35 Electromagnetic Compatibility Information 36 Table 3 Guidance and declaration of manufacturer-electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-
4-3 IEC 60601 test level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz Compliance level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz 385MHz, 27V
/m 385MHz, 27V
/m 450MHz, 28V
/m 450MHz, 28V
/m 710MHz,745 MHZ,780MHz 9V/m 710MHz,745 MHZ,780MHz 9V/m 810MHz,870 MHZ,930MHz 28V/m 810MHz,870 MHZ,930MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 2450MHz, 28V
/m 2450MHz, 28V
/m 5240MHz,5500 MHZ,5785MHz 9V/m 5240MHz,5500 MHZ,5785MHz 9V/m Electromagnetic environment
-guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended seperation distance 80 MHz to 800 MHz 800 MHz to 2.7 Ghz where P is the maximum output power rating of the transmitter in watts (W) according to the transm-
itter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:
Electromagnetic Compatibility Information 37 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 W 0.01 0.1 1 10 100 Separation distance according to frequency of transmitter m 800 MHz to 2.7 GHz 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 80 MHz to 800 MHz 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 th frequency range applies. e higher NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
1 | DBP1358b-FDA Manual | Users Manual | 631.69 KiB |
Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1358b Arm Type Document No.:JDBP-5404-050 VersionZ Date of Issue2018.12 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 Safety Notice ............................................................... 02
......................................................... 06 Unit Illustration
..................................... 09 Important Testing Guidelines 10 Quick Start ................................................................. Unit Operation ........................................................... 11 Battery Installation .................................................. 11 System Settings ........................................................ 12 Applying the Arm Cuff ............................................. 14 Testing ..................................................................... 15 Power Off ................................................................ 18 Memory Check ........................................................ 19 Memory Deletion ..................................................... 20 Last 3 Tests Average ................................................. 21 Low Battery Indicator ............................................. 22 Bluetooth requirements ........................................... 23 Troubleshooting ...................................................... 25
........................................ 26 Blood Pressure Information
................................................... 29 Blood Pressure QA
............................................................... 30 Maintenance
............................................................. 32 Specifications Warranty .................................................................... 34 Electromagnetic Compatibility Information .............. 35 1 Safety Notice 2 Thank you for purchasing the DBP-1358b Blood Pressure Monitor. The unit has been constructed using reliable circuitry and durable materials. Used properly, this unit will provide years of satisfactory use. Measure blood pressure(systolic and diastolic)and pulse rate of adults and adolecents age 12 through 21years of age. All functions can be used safely and values can be read out in one LCD DISPLAY. Measurement position is on adult upper arm only. 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 81060-2-30) 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 oC, 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 oC, 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. Safety Notice 3 Safety Notice 4 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. 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 arm cuff. Do not attempt to repair. 19. Use only the approved arm cuff for this unit. Use of other arm cuffs may result in incorrect measurement results. 20. The system might produce incorrect readings if stored or used outside 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. 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. Only use a recommended AC adaptor double-insulated complying with EN 60601-1 and EN 60601-1-2. An unauthorized adapter may cause fire and electric shock. This ME equipment or ME systems should be only used in shielded location. 29. Advising operator that Instruction manual/ Booklet must be consulted. 30. Do not use the device during transport vehicles for influencing measurement accuracy, such as patient transport in an ambulance or helicopter. 31. Contains small parts that may cause a chocking hazard if swallowed by infants. 32. Please align the polarities of each battery with the +ve and -ve signs imprinted on the battery housing when you replace the batteries . 33 34.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. 35.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 the unit, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. WARNING SIGNS AND SYMBOLS USED Keep Dry 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. Safety Notice Federla Commulcation Commission (FCC) Interference Statement 5 Unit Illustration 6 1.This device complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. 2.This device is verified to comply with part 15 of the FCC Rules for use with cable television service. 3.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. 4.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. 5.This equipment complies with radio frequency exposure limits set forth by the FCC for an uncontrolled environment. 6. This device must not be co-located or operating in conjunction with any other antenna or transmitter. 7.This equipment should be installed and operated with a minimum distance of 70cm between the device and the user or bystanders. Monitor Unit Systolic Blood Pressure Diastolic Blood Pressure
" M " Button
" " Button
"SET" Button Air Jack Pulse Rate AC Adapter Jack Battery cover Unit Illustration Arm Cuff 7 Unit Illustration 8 Contents 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 0 . 4 c m (
2
~
1 M R T A F E L
) h c n 0 . 8 i
~
M a i n A r t y r e I N D X E Arm Cuff Air Plug Air Tube Display Groups 43 Low Battery Indicator WHO Blood Pressure Classification Indicator mmHg kPa Last 3 Results Average Irregular Heartbeat Indicator AVG
(( )) Time Date D No M Systolic Blood Pressure Diastolic Blood Pressure Pulse Rate Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1358b Arm Type 2.Owner's Manual 1.Monitor Unit M R T A F E L
) h c n 0 . 8 i
~
M a i n A r t y r e I N D X E 4.Storage Bag 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 0 . 4 c m (
2
~
1 3.Arm Cuff 5.2MOPPMedical AC Adapter(DC6.0 V,600mA)
(recommended, not provided) Important Testing Guidelines 9 Quick Start 10 Avoid eating, exercising, and bathing for 30 minutes prior to testing. Sit in a calm environment for at least 5 minutes prior to testing. 1. 2. Do not stand while testing. Sit in a relaxed position while keeping your arm level with 3 your heart. 4. Avoid speaking or moving body parts while testing. 5. While testing, avoid strong electromagnetic interference such as microwave ovens and cell phones. 6
. Wait 3 minutes or longer before re-testing. Try to measure your blood pressure at the same time each day for consistency. 7 8
. Test comparisons should only be made when monitor is used on the same arm, 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. 1. Install batteries 2. Insert cuff air plug into the left side of monitor unit. (See Figure B)
. (See Figure A ) Figure A Figure B 3. Remove thick clothing from the arm area. 4. Rest for several minutes prior to testing. Sit down in a quietplace comfortably , back and arm support on a desk or table ,withyour legs uncrossed ,your arm resting on a firm and your feet flat on the floor. (See Figure C ) Figure C 5. Apply cuff to your left arm and middle of the cuff at the level of your heart. Bottom of cuff should be placed approximately 1-2cm (1/2'') above elbow joint. (See Figures D&E) 1
-
2 c m
(
0.4
-
0.8
''
) Figure D Figure E 6. Press
"
"
Button to start testing. Unit Operation Battery Installation Slide battery cover off as indicated by arrow. Install 4 new AAA alkaline batteries according to polarity. Close battery cover. 11 Unit Operation System Settings 12 With power off, press "SET" button to activate System Settings. The Memory Group icon flashes. 1. Select Memory Group While in the System Setting mode, you may accumulate test results into 2 different groups. This allows multiple users to save individual test results (up to 60 memories per group.) Press " M " button to choose a group setting. Test results will automatically store in each selected group. AC Adapter jack is on the right side of the monitor. Medical AC adapter(DC 6.0 V,600mA) can be used with the device (recommended, not provided). The adapter connect pin should be positive inside and negative outside with a 2.1mm coaxial joint. Do not use another type of AC adapter as it may harm the unit. 2. Time /Date Setting Press "SET" button again to set the Time/Date mode. Set the month first by adjusting the
" M " button. Press "SET " button again to confirm current month. Continue setting the day, hour and minute in the same way. Every time the " SET " button is pressed, it will lock in your selection and continue in succession (month, day, hour, minute.) AC Adapter Jack Note:Power supply is specified as part of ME EQUIPMENT. M D Unit Operation 13 Unit Operation 14 3.Voice Setting Press "SET" button to enter voice setting mode. Set the voice format ON or OFF by pressing the "M" button. Applying the Arm Cuff 1. Firmly insert air plug into opening located on left side of monitor unit. 4.volum setting Press "SET" button to enter volume setting mode. Set the voice volume by adjusting the "M"
button. There are six volume levels. 2. With sticky nylon section facing outward, insert end of cuff underneath metal ring
. of cuff 3. Fasten cuff about 1-2cm (0.4-0.8'') above the elbow joint. For best results apply cuff to bare arm and keep level with heart while testing
. 1
-
2 c m
(
0.4
-
0.8
''
) 5. Saved Settings While in any setting mode, press "
All information will be saved.
" button to turn the unit off. Note: If unit is left on and not in use for 3 minutes, it will automatically save all information and shut off. Note: Do not insert air plug into opening located on right side of monitor unit. This opening is designed for an optional power supply only. Unit Operation 15 Unit Operation 16 Testing Press " " button to turn the unit on. 1. Power On second as unit performs a quick diagnosis. is ready for testing The LCD screen will appear for one A voice tone will indicate when unit mmHg kPa 43 AVG
(( )) D No M Note: Unit will not function if residual air from previous testing is present in cuff. The LCD will flash " " until pressure is stabilized. 2. Pressurization The unit will automatically inflate to the proper shelf and stop inflating. During this time, please keep quiet. mmHg M D Note: Pressurization will gradually subside and ultimately stop when cuff is not properly applied to the arm. If this occurs, press button to turn the unit off. Unit Operation 17 Unit Operation 18 3. Testing After cuff inflation, air will slowly subside as indicated by the corresponding cuff pressure value. A flashing " " will appear simultaneously on screen signaling heart beat detection. mmHg M D Note: Keep relaxed during testing. Avoid speaking or moving body parts. 4. Result Display corresponding WHO Classification. The screen will display measurements for systolicand diastolic blood pressure with voice broadcast. A indicator representing the current measurement will appear next to the Irregular Heartbeat Indicator 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. 5. Deleting/Storing Test Results User may delete their current test result due to unfavorable testing conditions or for any other reason. To delete the last test result, press the "SET" button after result is displayed. If result is not deleted, it will automatically store by date within the previously configured Memory Group. Note: Be sure the appropriate Memory Group selection is made prior to testing. If the number of tests surpasses the allotted 60 memories per group, the most recent tests will appear first, thus eliminating the oldest readings. Indicator mmHg M D Note: Refer to Page 23~24 for detail WHO Blood Pressure Classification Information. Power Off turn off the power itself about 3 minutes no operation in any mode.
" button can be pressed to turn off the unit in any mode. The unit can The "
Safety Precaution: If pressure in arm cuff becomes too extreme while testing, press the "
dissipate once the unit is off.
" button to turn power off. The cuff pressure will rapidly Unit Operation 19 Unit Operation 20 Memory Deletion Memory for a selected group may be deleted while in Memory Check mode. Press and hold the " SET " button for approximately 3 seconds to delete all memory records from the selected group Press the "
with voice broadcast "Memory Clear"
and then transfer into testing mode.
" button to turn the unit off. Memory Check With power off, you may check past test results by using the " M " button. The most recent test result and oldest test result in memory can be viewed by pressing and holding the " M " button upon activating test results you can press the M button to scroll through all test results stored in memory. mmHg D No M M D Note: Previous test results will only be displayed from the most recently used memory group. To check previous test results in other memory groups, you must first select the desired group and then turn monitor off.
(See "Select Memory Group" on Page 10.) Note: Memory cannot be recovered once it has been deleted. Unit Operation Last 3 Tests Average With power off, press the " M " button to activate screen display. After the unit 21 Unit Operation Low Battery Indicator 22 4 short warning beeps sound when battery life is depleting and unable to inflate cuff for performs a self diagnosis, the screen will display the average test results from the last 3 testing. The " " appears simultaneously for approximately 5 seconds prior to shutting readings of the last group used with voice broadcast
. The " " symbol will appear along with the corresponding WHO Blood Pressure Indicator. The Memory Check mode can be accessed by pressing the "M " button. To check the average results from other groups, select off. Replace batteries at this time. No memory loss will occur throughout this process. the desired group first prior to activating the " M " button in the off position.
(See Select
"
Memory Group on Page 10.)
"
mmHg AVG M D Static Pressure Measurement In the power down state, press and hold the " " button, and theninstall the batteries. Until the LCD screen is full, release the " " button. When the LCD screen displays the double zero, the bloodpressure meter is in static state. Software version is displayed at the heart rate . mmHg M D Note: Only Service personnel permitted to access to this mode, the mode unavailable in normal use. Unit Operation Bluetooth requirements The monitor requires a device with:
. Bluetooth 4.0 or later
. Android 5.0 or later
. IOS 9.0 or later And works with:
. iphone , iPod, iPad
. Android Phones and Tablets Wireless communication Frequency range : 2.4 Ghz (2400-2483.5 MHz) Modulation : GFSK Antenna gain:0.5dBi 23 Unit Operation 24 Bluetooth connection Using for the first time 1. Download the free JOYTECH healthcare 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. Pairing your monitor with a Smart Device The date and time on your monitor will automatically be set when you pair it with your smart device. 1. Make sure the Bluetooth in your smart device is turned on. 2. Open the app on your smart device and follow the set-up and pairing instructions. 3. Confirm the monitor is connected successfully. If the monitor is connected successfully to the smart device, bLE on will appear on the monitor display. mmHg
/
Unit Operation Troubleshooting 25 Blood Pressure Information 26 Problem Possible Cause Solution Cuff is too tight or not properly positioned on the arm Firmly reposition cuff approximately
(
above the elbow joint
( See Page 12) 1-2cm 1/2"
) Blood pressure results are not within typical range Inaccurate test results due to body movement or monitor movement Sit in a relaxed position with arm placed near heart. Avoid speaking or moving body parts while testing. Make sure the monitor unit is placed in a stationary position throughout the testing period.
( See Page 7) Cuff fails to inflate properly Make sure hose is properly fastened to cuff and monitor unit Improper operation Read user manual carefully and re-test properly.
" "displayed Connection failure./
Data is not being transmitted Pressurization is over cuff rated pressure 300mmHg The blood pressure monitor might not be porperly placed within the smart devices tranmission range and is too far from the smart device. Read user manual carefully and re-test properly. If there are no causes of data transmission interference found near the blood pressure monitor, move the blood pressure monitor within 16ft.(5m) of the smart device and try again The blood pressure did not pair successfully to the smart device Try to pair the devices once again. The application on the smart device is not ready. Check the application then try sending the data again. 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 200 150 100 50 g H m m 6 12 18 Time of day 24 Example: fluctuation within a day (male, 35 years old) Blood Pressure Information 27 WHO Blood Pressure Classification Indicator The DBP-1358b is equipped with a classification indicator based on established guidelines from the World Health Organization. The chart below (color coded on monitor unit) indicates test results. Blood Pressure Information Health Reminder 28 Hypertension is a dangerous disease that can affect the quality of life. It can lead to a lot of problems including heart failure, kidney failure, and cerebral hemorrhaging. By maintaining a healthy lifestyle and visiting your physician on a regular basis, hypertension and relative diseases are much easier to control when diagnosed in their Severe Hypertension Moderate Hypertension Mild Hypertension High-n ormal Normal Optimal Mild Hypertension mmHg M D
:
Blood Pressure Classification Indicator early stages. Systolic
( mmHg ) 180 160 140 130 120 Severe Hypertension Moderate Hypertension Mild Hypertension High-normal Normal Optimal 80 85 90 100 110 Diastolic
( mmHg ) Note: Do not be alarmed if an abnormal reading occurs. blood pressure occurs after 2-3 readings are taken at the same time extended period of time. Consult your physican if test results remain abnormal. A better indication of an individual's each day over an Blood Pressure QA 29 Maintenance 30 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. Make sure bottom of the cuff is approximately 1-2cm (1/2'') above the elbow joint. 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. 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 arm? What is the difference?
A: Either arm can be used when testing, however, when comparing results, the same arm should be used. Testing on your left arm 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 expose unit directly under sunshine. 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. Maintenance 31 Specifications 32 Cuff Cleaning:
Do not soak cuff in water!
4. 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 differentusers. Apply a small amount of rubbing alcohol to Product Description Arm-type Fully Automatic Blood Pressure Monitor Model Display DBP-1358b LCD Digital Display Size: 45.7mm 62mm 5. Do not use petrol, thinners or similar solvents. Measurement Method Oscillometric Method 6. Remove batteries when not in operation for an extended period of time. Pulse 30 ~ 180 Beats/Minute Systolic Pressure 60mmHg28 0mmHg Diastolic Pressure 30mmHg200mmHg Pressure Pressure 0mmHg300mmHg 3mmHg Measurement Range 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. Pressurization Memory Function Power Source Battery Life Unit Weight Pulse Automatic Pressurization 5%
120 Memories in Two Groups with Date and Time Irregular Heartbeat Detection WHO Classification Indicator Last 3 Results Average Low Battery Detection Automatic Power-Off Voice Bluetooth 4 AAA batteries Approximately 2 m onths at 3 tests per day Approx.425g (14.99 oz.) (excluding battery) Unit Dimensions Approx.131.5 x 101.8 x 44.1mm(L x W x H) Cuff Circumference Approx.135 (W)485(L) mm
(Medium cuff: Fits arm circumference 22-36 cm) Temperature 10 ~ 40 (50 ~104
) Operating Environment Humidity Pressure 15%93%RH 700hPa~1060hPa Specifications 33 Warranty 34 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 Pressure Monitor due to improper handling. Please contact local retailer for details. Storage Environment Temperature:
Humidity
(-13 ~158
)
-25 ~70 93% RH Classification:
Internal Powered Equipment,Type BF . Cuff is the Applied Part Ingress Protection rating:
Specifications are subject to change without notice. IP 20,Indoor Used Only 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. ANSI/AAMI ISO 81060-2, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type. (Cardiovascular) 3. AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)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. 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. Electromagnetic Compatibility Information 35 Electromagnetic Compatibility Information Table 2 36 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. 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. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Emissions test Compliance Radiated emission CISPR 11 Group 1, class B. Conducted emission CISPR 11 Group 1, class B. Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Class A Complies 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 Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV,4 kV, 8 kV, 15 kV air 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 %. Electrostatic transient/burst IEC 61000-4-4 2 kV , 100kHz, for AC power port 2 kV , 100kHz, for AC power port Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 0.5kV, 1kV
(differential mode) 0.5kV, 1kV
(differential mode) Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT;
250/300 cycle 0 % UT;
250/300 cycle Voltage dips, short interrupti-
ons and voltage variations on p-
ower supply in-
put lines IEC 61000-4-11 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 37 Electromagnetic Compatibility Information 38 38 Table 3 Guidance and declaration of manufacturer-electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-
4-3 IEC 60601 test level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz Compliance level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz 385MHz, 27V
/m 385MHz, 27V
/m 450MHz, 28V
/m 450MHz, 28V
/m 710MHz,745 MHZ,780MHz 9V/m 710MHz,745 MHZ,780MHz 9V/m 810MHz,870 MHZ,930MHz 28V/m 810MHz,870 MHZ,930MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 2450MHz, 28V
/m 2450MHz, 28V
/m 5240MHz,5500 MHZ,5785MHz 9V/m 5240MHz,5500 MHZ,5785MHz 9V/m Electromagnetic environment
-guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended seperation distance 80 MHz to 800 MHz 800 MHz to 2.7 Ghz where P is 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 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 W 0.01 0.1 1 10 100 Separation distance according to frequency of transmitter m 800 MHz to 2.7 GHz 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 80 MHz to 800 MHz 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 th frequency range applies. e higher NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
1 | DBP1359b-FDA Manual | Users Manual | 688.64 KiB |
Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1359b Arm Type Document No.:JDBP-5504-050 Version: Z Date of Issue: 2018.12 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 Safety Notice 2 Thank you for purchasing the DBP-1359b Blood Pressure Monitor. The unit has been constructed using reliable circuitry and durable materials. Used properly, this unit will provide yeas of satisfactory use. Measure blood pressure(systolic and diastolic)and pulse rate of adults and adolecents age 12 through 21years of age. All functions can be used safely and values can be read out in one LCD DISPLAY. Measurement position is on adult upper arm only. 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 81060-2-30) 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 oC, 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 oC, 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. 1 Contents Safety Notice ............................................................... 02 Unit Illustration ......................................................... 06 Important Testing Guidelines ..................................... 09 Quick Start ................................................................. 10 Unit Operation ........................................................... 11 11 Battery Installation .................................................. System Settings ........................................................ 12 Applying the Arm Cuff ............................................. 14 Testing ..................................................................... 15 Power Off ................................................................ 18 Memory Check ...................................................... 19 Last3 Tests Average .......... ...................................... 20 Memory Deletion ..................................................... 21 Low Battery Indicator ............................................. 21 Bluetooth requirements ........................................... 22 Troubleshooting ...................................................... 24 Blood Pressure Information ........................................ 25 Blood Pressure Q A ................................................... 28 Maintenance ............................................................... 29 Specifications ............................................................. 31 Warranty .................................................................... 33 Electromagnetic Compatibility Information .............. 34 Safety Notice 3 Safety Notice 4 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. 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 arm cuff. Do not attempt to repair. 19. Use only the approved arm cuff for this unit. Use of other arm cuffs may result in incorrect measurement results. 20. The system might produce incorrect readings if stored or used outside 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. 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. Dispose batteries properly; observe local laws and regulations. 27. Only use a recommended AC adaptor double-insulated complying with EN 60601-1 and EN 60601-1-2. An unauthorized adapter may cause fire and electric shock. 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. Please align the polarities of each battery with the +ve and -ve signs imprinted on the battery housing when you replace the batteries . 32.This ME equipment or ME systems should be only used in shielded location. 33.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. 34.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 the unit, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. WARNING SIGNS AND SYMBOLS USED Keep Dry 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. Safety Notice Federla Commulcation Commission (FCC) Interference Statement 5 Unit Illustration 6 1.This device complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. 2.This device is verified to comply with part 15 of the FCC Rules for use with cable television service. 3.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. 4.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. Monitor Unit Systolic Blood Pressure Diastolic Blood Pressure M
"
" Button
" " Button
"SET" Button Air Jack Pulse Rate AC Adapter Jack Battery cover Unit Illustration Arm Cuff Medium size cuff (fits arm circumference: 22.0 cm -36.0 cm). 7 Unit Illustration Contents 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 4
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2
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1 M R T A F E L
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M a i n A r t y r e I N D X E 8 Owner's Manual Arm-type Fully Automatic Digital Blood Pressure Monitor Model DBP-1359b Arm Type Arm Cuff Air Plug Air Tube If air is leaking from the arm cuff, replace the arm cuff with a new one. It is generally recommended to have the cuff replaced timely to ensure correct functioning and accuracy. Please consult your local authorized distributor or dealer. 1.Monitor Unit 2.Owner's Manual Display Groups WHO Blood Pressure Classification Indicator Last 3 Results Average Irregular Heartbeat Indicator Low Battery Indicator Time and Data Systolic Blood Pressure Diastolic Blood Pressure Pulse Rate M R T A F E
) h c 8 i n L
. 4.Storage Bag 2 2 ~ 3 6 c m 8 . 6 ~ 1 4 . 2 i n c h ) 0
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4
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2
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1 i n A r M a y r e t I N X E D 3.Arm Cuff 5.2MOPPMedical AC Adapter(DC6.0 V,600mA)
(recommended, not provided) Important Testing Guidelines 9 Quick Start 10 Avoid eating, exercising, and bathing for 30 minutes prior to testing. Sit in a calm environment for at least 5 minutes prior to testing. 1. 2. Do not stand while testing. Sit in a relaxed position while keeping your arm level with 3 your heart. 4. Avoid speaking or moving body parts while testing. 5. While testing, avoid strong electromagnetic interference such as microwave ovens and cell phones. 6
. Wait 3 minutes or longer before re-testing. Try to measure your blood pressure at the same time each day for consistency. 7 8
. Test comparisons should only be made when monitor is used on the same arm, 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. 1. Install batteries 2. Insert cuff air plug into the left side of monitor unit. (See Figure B)
. (See Figure A ) Figure A Figure B 3. Remove thick clothing from the arm area. 4. Rest for several minutes prior to testing. Sit down in a quietplace comfortably , back and arm support on a desk or table ,withyour legs uncrossed ,your arm resting on a firm and your feet flat on the floor. (See Figure C ) Any blood pressure recording can be affected by the following factors:
1. The position of the subject, his or her physiologic condition;
2. The performance and accuracy of the device;
3. Cuff size: too small cuff (bladder) will produce a higher blood pressure value than usual, too big cuff (bladder) will produce a lower blood pressure value;
4. Measuring position does not keep level with your heart;
5. Speaking or moving body parts while testing;
6. Not relaxing for about 5 minutes before taking the measurement. Figure C 5. Apply cuff to your left arm and middle of the cuff at the level of your heart. Bottom of cuff should be placed approximately 1-2cm (1/2'') above elbow joint. (See Figures D&E) 1
-
2 c m
(
0.4
-
0.8
''
) Figure D Figure E 6. Press " " Button to start testing. Unit Operation Battery Installation Slide battery cover off as indicated by arrow. Install 4 new AAA alkaline batteries according to polarity. Close battery cover. 11 Unit Operation System Settings With power off, press "SET" button to activate System Settings. The Memory Group icon flashes. 1. Select Memory Group While in the System Setting mode, you may accumulate test results into 2 different groups. This allows multiple users to save individual test results (up to 60 memories per group.) Press " M " button to choose a group setting. Test results will automatically store in each selected group. AC Adapter jack is on the back side of the monitor. Medical AC adapter(DC 6.0 V,600mA) can be used with the device (recommended, not provided). The adapter connect pin should be positive inside and negtive outside with a 2.1mm coaxial joint. Do not use any other type of AC adapter as it may harm the unit. 2. Time/Date setting PressSET button again to set the Time/Date mode. Set the year first by adjusting the M button. PressSET button again to confirm curret month. Continue setting the date, hour and minute in the same method. Every time the SET button is pressed, it will lock in your seletion and continue in succession ( month,date,hour, minute) AC Adapter Jack Note:Power supply is specified as part of ME EQUIPMENT.
/
Unit Operation 3.Voice Setting Press "SET" button to enter voice setting mode. Set voice format ON or OFF by pressing the "M" button. 13 Unit Operation Applying the Arm Cuff 1. Firmly insert air plug into opening located on left side of monitor unit. 12 14 4.Volume Setting Press "SET" button to enter volume setting mode. Set the voice volume by adjusting the "M" button . There are six volume levels. 5. Saved Settings While in any setting mode, press "
information will be saved.
" button to turn the unit off. All Note: If unit is left on and not in use for 3 minutes, it will automatically save all information and shut off. 2. With sticky nylon section facing outward, insert end of cuff underneath metal ring
. of cuff 3. Fasten cuff about 1-2cm (0.4-0.8'') above the elbow joint. For best results apply cuff to bare arm and keep level with heart while testing
. 1
-
2 c m
(
0.4
-
0.8
''
) Note: Do not insert air plug into opening located on right side of monitor unit. This opening is designed for an optional power supply only. Unit Operation 15 Unit Operation 16 Testing 1. Power On Press and hold "
for one second as unit performs a quick diagnosis. A voice tone will indicate when unit is ready for testing. button to turn the unit on. The LCD screen will appear 2. Pressurization The unit will automatically inflate to the proper shelf and stop inflating. During this time, please keep quiet. mmHg
/
Note: Pressurization will gradually subside and ultimately stop when cuff is not properly applied to the arm. If this occurs, press to turn the unit off. button 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 17 Unit Operation 18 3. Testing After cuff inflation, air will slowly subside as indicated by the corresponding cuff pressure value. A flashing " " will appear simultaneously on screen signaling heart beat detection. mmHg
/
Note: Keep relaxed during testing. Avoid speaking or moving body parts. 4. Result Display 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. Indicator mmHg
/
Note: Refer to Page 23~24 for detail WHO Blood Pressure Classification Information. Irregular Heartbeat Indicator If the monitor detects an irregular heart rhythm two or more times during the measuring process, the Irregular Heartbeat Symbol " "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. 5. Deleting/Storing Test Results User may delete their current test result due to unfavorable testing conditions or for any other reason. To delete the last test result, press the "SET" button after result is displayed. If result is not deleted, it will automatically store by date within the previously configured Memory Group. Note: Be sure the appropriate Memory Group selection is made prior to testing. If the number of tests surpasses the allotted 60 memories per group, the most recent tests will appear first, thus eliminating the oldest readings. Power Off turn off the power itself about 3 minutes no operation in any mode.
" button can be pressed to turn off the unit in any mode. The unit can The "
Safety Precaution: If pressure in arm cuff becomes too extreme while testing, press the "
dissipate once the unit is off.
" button to turn power off. The cuff pressure will rapidly Unit Operation 19 Unit Operation 20 Last 3 Tests Average With power off, press the " M " 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 with voice broadcast. The " " symbol will appear along with the corresponding WHO Blood Pressure Indicator. The Memory Check mode can be accessed by pressing the "M " buttons. To check the average results from other groups, select the desired group first prior to activating the " M " button in the off position. (See "Select Memory Group" on Page 11.) Memory Check With power off, you may check past test results by using the " M " button. The most recent test result and oldest test result in memory can be viewed by pressing and holding the " M " button upon activating test results you can press the M button to scroll through all test results stored in memory. mmHg
/
No
/
Note: Previous test results will only be displayed from the most recently used memory group. To check previous test results in other memory groups, you must first select the desired group and then turn monitor off.
(See "Select Memory Group" on Page 10.) Unit Operation Memory Deletion Memory for a selected group may be deleted while in Memory Check mode. Press and hold the " SET " button for approximately 3 seconds to delete all memory records from the selected groupwith voice broadcast "Memory Clear" and then transfer into testing mode. Press the " " button to turn the unit off. 21 Note: Memory cannot be recovered once it has been deleted. Low Battery Indicator The unit will broadcast "Low Battery" when battery life is depleting and unable to inflate cuff for testing. The " " appears simultaneously for approximately 5 seconds prior to shutting off. Replace batteries at this time. No memory loss will occur throughout this process. Unit Operation Bluetooth requirements The monitor requires a device with:
22
. Bluetooth 4.0 or later
. Android 5.0 or later
. IOS 9.0 or later And works with:
. iphone , iPod, iPad
. Android Phones and Tablets Wireless communication Frequency range : 2.4 Ghz (2400-2483.5 MHz) Modulation : GFSK Antenna gain:0.5dBi Unit Operation Bluetooth connection Using for the first time 1. Download the free JOYTECH healthcare 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. Pairing your monitor with a Smart Device The date and time on your monitor will automatically be set when you pair it with your smart device. 1. Make sure the Bluetooth in your smart device is turned on. 2. Open the app on your smart device and follow the set-up and pairing instructions. 3. Confirm the monitor is connected successfully. 23 Unit Operation Troubleshooting 24 Problem Possible Cause Solution Cuff is too tight or not properly positioned on the arm Firmly reposition cuff approximately
(
above the elbow joint
( See Page 12) 1-2cm 1/2"
) Blood pressure results are not within typical range Inaccurate test results due to body movement or monitor movement Sit in a relaxed position with arm placed near heart. Avoid speaking or moving body parts while testing. Make sure the monitor unit is placed in a stationary position throughout the testing period.
( See Page 7) If the monitor is connected successfully to the smart device, bLE on will appear on the
" "displayed monitor display. mmHg
/
Connection failure./
Data is not being transmitted Cuff fails to inflate properly Make sure hose is properly fastened to cuff and monitor unit Improper operation Read user manual carefully and re-test properly. Pressurization is over cuff rated pressure 300mmHg The blood pressure monitor might not be porperly placed within the smart devices tranmission range and is too far from the smart device. Read user manual carefully and re-test properly. If there are no causes of data transmission interference found near the blood pressure monitor, move the blood pressure monitor within 16ft.(5m) of the smart device and try again The blood pressure did not pair successfully to the smart device Try to pair the devices once again. The application on the smart device is not ready. Check the application then try sending the data again. Blood Pressure Information 25 Blood Pressure Information 26 WHO Blood Pressure Classification Indicator The DBP-1359b is equipped with a classification indicator based on established guidelines from the World Health Organization. The chart below (color coded on monitor unit) indicates test results. 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. 200 150 100 50 g H m m Upper curve : systolic blood pre ssur e Lower curve: diastolic blood pressure Mild Hypertension 6 12 18 Time of day 24 Example: fluctuation within a day (male, 35 years old)
:
Blood Pressure Classification Indicator Severe Hypertension Moderate Hypertension Mild Hypertension High-n ormal Normal Optimal mmHg
/
Blood Pressure Information Health Reminder Hypertension is a dangerous disease that can affect the quality of life. It can lead to a lot of problems including heart failure, kidney failure, and cerebral hemorrhaging. By maintaining a healthy lifestyle and visiting your physician on a regular basis, hypertension and relative diseases are much easier to control when diagnosed in their early stages. Systolic
( mmHg ) 180 160 140 130 120 Severe Hypertension Moderate Hypertension Mild Hypertension High-normal Normal Optimal 80 85 90 100 110 Diastolic
( mmHg ) Note: Do not be alarmed if an abnormal reading occurs. blood pressure occurs after 2-3 readings are taken at the same time extended period of time. Consult your physician if test results remain abnormal. A better indication of an individual's each day over an 27 Blood Pressure QA 28 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. Make sure bottom of the cuff is approximately 1-2cm (1/2'') above the elbow joint. 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. 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 arm? What is the difference?
A: Either arm can be used when testing, however, when comparing results, the same arm should be used. Testing on your left arm 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. Maintenance 1. Avoid dropping, slamming, or throwing the unit. 29 Maintenance 30 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. 5. Do not use petrol, thinners or similar solvents. 2. Avoid extreme temperatures. Do not expose unit directly under sunshine. 6. Remove batteries when not in operation for an extended period of time. 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. 7. Do not disassemble product. 8. It is recommended the performance should be checked every 2 years. 9. Expected service life: Approximately three years at 10 tests per day. 10.No service and maintenance while it is in use and maintenance only be performed by service personnel. Service and maintenance require parts, repair, technical support will be provided. Specifications 31 Specifications Product Description Arm-type Fully Automatic Blood Pressure Monitor Model Display DBP-1359b LCD Digital Display Size: 69mm 67mm Measurement Method Oscillometric Method Systolic Pressure 60mmHg28 0mmHg Diastolic Pressure 30mmHg200mmHg Measurement Range Pressure Pressure 0mmHg300mmHg 3mmHg or 2% of the reading above 200 mmHg Pressurization Memory Function Pulse 30 ~ 180 Beats/Minute Pulse Automatic Pressurization 5%
120 Memories in Two Groups with Date and Time Irregular Heartbeat Detection WHO Classification Indicator Last3 Tests Average Low Battery Detection Automatic Power-Off voice Backlight Power Source Battery Life Unit Weight Unit Dimensions Cuff Circumference Bluetooth 4 AA Abatteries or Medical AC Adapter(DC6.0V, 600mA)
(recommended, not provided) Approximately 2 months at 3 tests per day Approx.480g (16.93 oz.) (excluding battery) Approx.131.2 x 101.8 x 44.1mm (L x W x H) Approx.135 (W)485(L) mm
(Medium cuff: Fits arm circumference 22-36 cm) Temperature Operating Environment Humidity 10 ~ 40 (50 ~104 15% ~ 93% RH
) Pressure 700hPa~1060hPa Storage Environment Temperature:
Humidity 32
)
(-13 ~158
-25 ~70 93% RH Classification:
Internal Powered Equipment,Type BF . Cuff is the Applied Part Ingress Protection Rating:
IP20, Indoor Use Only Specifications are subject to change without notice. International Standards:
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. ANSI/AAMI ISO 81060-2, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type. (Cardiovascular) 3. AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)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. Correct Disposal of This Product
(Waste Electrical & Electronic Equipment) This marking shown on the product indicates that it should not be disposed with other household waste at the end of its life. To prevent potential harm to the environment or to human health, please separate this product from other types of wastes and recycle it responsibly. When disposing this type of product, contact the retailer where product was purchased or contact your local government office for details regarding how this item can be disposed in an environmentally safe recycling center. Business users should contact their supplier and check the terms and conditions of the purchasing agreement. This product should not be mixed with other commercial wastes for disposal. This product is free of hazardous materials. Warranty 33 Electromagnetic Compatibility Information 34 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 Pressure Monitor due to improper handling. Please contact local retailer for details. 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. 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. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Emissions test Compliance Radiated emission CISPR 11 Group 1, class B. Conducted emission CISPR 11 Group 1, class B. Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Class A Complies Electromagnetic Compatibility Information 35 Electromagnetic Compatibility Information 36 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 Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV,4 kV, 8 kV, 15 kV air 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 %. Electrostatic transient/burst IEC 61000-4-4 2 kV , 100kHz, for AC power port 2 kV , 100kHz, for AC power port Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 0.5kV, 1kV
(differential mode) 0.5kV, 1kV
(differential mode) Mains power quality should be that of a typical commercial or hospital environment. 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT;
0,5 cycle At 0, 45, 90, 135, 180, 225
, 270 and 315 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT; 1 cycle and 70 % UT;
25/30 cycles Single phase:
at 0 0 % UT;
250/300 cycle 0 % UT;
250/300 cycle Voltage dips, short interrupti-
ons and voltage variations on p-
ower supply in-
put lines IEC 61000-4-11 Mains power quality should be that of a typical commercial or hospital environment. 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. Table 3 Guidance and declaration of manufacturer-electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-
4-3 IEC 60601 test level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz Compliance level 3V for 0.15-
80MHz; 6V in ISM and amate
-ur radio bands between0.15-
80MHz 385MHz, 27V
/m 385MHz, 27V
/m 450MHz, 28V
/m 450MHz, 28V
/m 710MHz,745 MHZ,780MHz 9V/m 710MHz,745 MHZ,780MHz 9V/m 810MHz,870 MHZ,930MHz 28V/m 810MHz,870 MHZ,930MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 1720MHz,1845 MHZ,1970MHz 28V/m 2450MHz, 28V
/m 2450MHz, 28V
/m 5240MHz,5500 MHZ,5785MHz 9V/m 5240MHz,5500 MHZ,5785MHz 9V/m Electromagnetic environment
-guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended seperation distance 80 MHz to 800 MHz 800 MHz to 2.7 Ghz where P is the maximum output power rating of the transmitter in watts (W) according to the transm-
itter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:
Electromagnetic Compatibility Information 37 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 W 0.01 0.1 1 10 100 Separation distance according to frequency of transmitter m 800 MHz to 2.7 GHz 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 80 MHz to 800 MHz 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 th frequency range applies. e higher NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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0.1 0. 3 87.6+0.0 114. 417):
5 171 58.1 size: o/mm x24mm Arm-Type Fully Automatic Digital Blood Pressure Monitor Manufacturers by JOYTECH Healthcare Co., Ltd. No. 365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City,311100 Zhejiang, China Power: 6.0V DC. 6W; (or Batteries 4 1.5V AA) Series number:
Manufacturing Dat:
FCC ID:2AQVU0005 Made in China Model: DBP-1307b
1 | Authorization Letter | Cover Letter(s) | 600.20 KiB |
: aR: UNL ERT (MEERA BEB) J > T ae | JOYTECH Healthcare Co., Ltd. Date: 03.22.2017 To: Federal Communications Commission, Authorization & Evaluation Division, 7435 Oakland Mills Road, Columbia, MD 21046 To Whom It May Concern:
The JOYTECH Healthcare Co., Ltd the undersigned, hereby authorizes Mr. TonyCL.Chen of TUV Rheinland Shanghai Co., Ltd, to act on the behalf of the JOYTECH Healthcare Co., Ltd solely in matters relating to the application for an FCC equipment authorization for FCC ID: 2AQVU0005 including the signing of documents in connection with this Application. Necessary acts carried out by JOYTECH Healthcare Co., Ltd on our behalf of the JOYTECH Healthcare Co., Ltd in connection with the Application shall have the same effect as acts of the JOYTECH Healthcare Co., Ltd The JOYTECH Healthcare Co., Ltd also hereby certify that no party to this application is subject to a denial of benefits, including FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Thank you for your attention to this matter. Yours Sincerely, Name : Lan "1 Pic
1 | Confidenital Letter | Cover Letter(s) | 503.43 KiB |
JOY TEZC VL RIE IT ERB BRA JOYTECH Healthcare Co., Ltd. Date: 03.22.2017 To: Federal Communications Commission, Authorization & Evaluation Division, 7435 Oakland Mills Road, Columbia, MD 21046 Re: JOYTECH Healthcare Co., Ltd. FCC ID: 2AQVU0005 FCC Part 15C Certification Confidentiality Request Gentlemen:
This letter is to comply with 47 CFR 0.457 and 0.459 pertaining to confidentiality material. JOYTECH Healthcare Co., Ltd requests that the following documents regarding this submission for FCC ID: 2AQVU0005 be kept confidential:
Exhibit Type Block Diagram Schematics Operational Description Part list Those documents contain detailed system and equipment description and related information about the product which JOYTECH Healthcare Co., Ltd considers to be confidential proprietary, a custom design and, otherwise, not releasable to the general public. Since this design is a basis form which future technological products will evolve, JOYTECH Healthcare Co., Ltd considers this information would be of benefit to its competitors, and that the disclosure of the information in these documents would give competitors an unfair advantage in the market. Yours Sincerely, Name : lan 1% ce {
Title: | Certificatfon Engi Pei Company: JOYTECH Hea theare Cp., Lt
1 | Declaration of difference | Attestation Statements | 231.28 KiB |
Multiple Models Statement Letter T o w h o m i t m a y c o n c e r n , W e , J O Y T E C H H E A L T H C A R E C O . , L T D . h e r e b y c o n f i r m t h a t t h e f a m i l y m o d e l s l i s t e d b e l o w . P r o d u c t : A r m - t y p e F u l l y A u t o m a t i c D i g i t a l B l o o d P r e s s u r e M o n i t o r F C C I D : 2 A Q V U 0 0 0 5 M o d e l l i s t :
D B P - 1 3 0 7 b , D B P - 1 3 0 5 b , D B P - 1 3 1 9 b , D B P - 1 3 1 8 b , D B P - 1 3 3 2 b , D B P - 1 3 3 3 b , D B P - 1 2 5 7 b , D B P - 1 3 5 8 b , D B P - 1 3 5 9 b T h e s e m o d e l s a r e i d e n t i c a l a s f o l l o ws :
E l e c t r o n i c s / e l e c t r i c a l d e s i g n s , i n c l u d i n g s o f t wa r e & f i r m w a r e P C B L a y o u t
(Others please specify):
T h e o n l y d i f f e r e n c e s b e t w e e n t h e s e m o d e l s a r e t h e f o l l o ws f o r m a r k e t i n g p u r p o s e :
Mo d e l N o . C o l o r C o n s t r u c t i o n D e s i g n / P h y s i c a l D e s i g n / E n c l o s u r e 1 . T h e a p p e a r a n c e s a r e d i f f e r e n t d u e t o d i f f e r e n t s h a p e s h e l l s u s e d . I t v e r i f i e d t h a t t h e m a t e r i a l s o f C o n s t r u c t i o n D e s i g n f o r a l l m o d e l s a r e t h e s a m e . 2 . T h e d i s p l a y s i z e s i n e a c h m o d e l a r e d i f f e r e n t , a n d t h e m o d e l wi t h l a r g e s t d i s p l a y c o n s i d e r e d a s t h e m a i n m o d e l .
( O t h e r s p l e a s e s p e c i f y ) :
T h e m o d e l D B P - 1 3 0 7 b wi t h l a r g e s t d i s p l a y t e s t e d a s t h e m a i n m o d e l , a d d i t i o n a l t e s t s p e r f o r m e d b a s e d o n a b o v e d i f f e r e n c e s . R e g a r d s , S i g n a t u r e :
P r i n t N a m e / T i t l e : Jing Cong / Certification engineer D a t e : 2019.11.08
frequency | equipment class | purpose | ||
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1 | 2019-11-14 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
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1 | Effective |
2019-11-14
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1 | Applicant's complete, legal business name |
JOYTECH HEALTHCARE CO., LTD.
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1 | FCC Registration Number (FRN) |
0027764067
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1 | Physical Address |
No.365, Wuzhou Road, Yuhang Economic Development Zone
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1 |
No.365, Wuzhou Road
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1 |
Hangzhou
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1 |
China
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app s | TCB Information | |||||
1 | TCB Application Email Address |
f******@tuv.com
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1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
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app s | FCC ID | |||||
1 | Grantee Code |
2AQVU
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1 | Equipment Product Code |
0005
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
L******** Y******
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1 | Title |
QA
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1 | Telephone Number |
0571-********
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1 | Fax Number |
0571-********
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1 |
c******@sejoy.com
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app s | Technical Contact | |||||
1 | Firm Name |
JOYTECH HEALTHCARE CO., LTD.
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1 | Name |
L****** Y******
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1 | Physical Address |
Yuhang Economic Development Zone
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1 |
Hangzhou
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1 |
China
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1 |
c******@sejoy.com
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app s | Non Technical Contact | |||||
1 | Firm Name |
TUV Rheinland (Shanghai) Co., Ltd.
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1 | Name |
T**** C******
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1 | Physical Address |
TUV Building I, No.177, Lane 777, West Guangzhong
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1 |
Shanghai
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1 |
China
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1 |
T******@tuv.com
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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) | Arm-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 | Output 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 |
MRT Technology (Suzhou) Co., Ltd.
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1 | Name |
M******** C********
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1 | Telephone Number |
+86-5******** Extension:
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1 |
m******@mrt-cert.com
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0024000 |
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