Kingyield BPW1, BPW2, BPW3, BPW5 User Manual

SMS-BPW1-A00
Shenzhen Kingyield Technology Co., Ltd.
Blood Pressure Monitor
Item No.: BPW1/2/3/5
SMS-BPW1-A00
Contents
1. Before Using the Device ......................................................................................................................................... 1
1.1 Indications For Use ................................................................................................................................................ 1
1.2 Important Safety Information and Precautions .................................................................................................. 1
1.3 About Blood Pressure ........................................................................................................................................... 2
2. Know Your Device .................................................................................................................................................... 2
3. Instruction For Use ................................................................................................................................................... 3
3.1 Before Taking a Measurement ..................................................................................................................... 3
3.2 Take a Measurement..................................................................................................................................... 3
4. Cleaning and Maintenance ..................................................................................................................................... 4
5. Troubleshooting ........................................................................................................................................................ 5
6. EMC Declaration ...................................................................................................................................................... 5
7. FCC Compliance ...................................................................................................................................................... 6
8. Specifications ............................................................................................................................................................ 7
9. Calibration and Service ........................................................................................................................................... 8
10. Warranty Information ............................................................................................................................................. 9
11. Symbols Use ......................................................................................................................................................... 10
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1. Before Using the Device
1.1 Indications For Use
This wrist blood pressure monitor is intended to be used to measure blood pressure and
pulse rate from the wrist by using the oscillometric method, at home or in medical centers.
This device is intended for use on adults only and is not for use on groups such as
neonatal babies, children, pregnant women, or pre-eclamptic patients.
1.2 Important Safety Information and Precautions
WARNING
Contact your physician if you suspect you have a medical issue.
• Not for use by children, pregnant women, or pre-eclamptic patients.
• If you suffer from arrhythmia, diabetes, blood circulation problems, or apoplexy, only use the device under a physician’s care.
• Prolonged over-inflation of the monitor will result in harmful injury to the patient.
• Do not use the device over a wound, as this can cause further injury.
• Too frequent measurements can cause injury due to blood flow interference.
Users should not attempt to modify the device in any way.
• Store device in a cool, dry place. Do not subject the device to extreme
temperatures, humidity, or sunlight. The device might not meet performance specifications if stored or used outside the ranges specified in the
“Specifications” section.
• Do not immerse the device in water or clean with cleaning products, alcohol, or
solvents. Carefully follow cleaning instructions provided.
If the equipment is not available for three months or more, please use the appropriate power adapter for recharging.
• Ensure that the device is used in the environment specified in the EMC declaration in this IM, otherwise, may result in improper operation.
• Use of this device adjacent to or stacked with other device should be avoided
because it could result in improper operation.
• This electrical medical equipment requires specific precautions regarding electromagnetic compatibility. It must be installed and used according to the electromagnetic information.
• Do not use the device where flammable gases or liquids are present.
Cannot be maintained while using.
The instruction manual contains reference technical instructions. Prospective users are patients.
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1.3 About Blood Pressure
BLOOD PRESSURE INDICATOR CHART
(World Health Organization (WHO) Blood Pressure Indicator)
* Consult Your Physician
When systolic and diastolic pressure falls into different categories, the higher pressure determines color code. Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/ stethoscope auscultatory method, within the limits prescribed by European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults. An irregular heartbeat rhythm is defined as a rhythm that is more than 25% slower or 25% faster from the average rhythm detected while the device is measuring the systolic blood pressure and the diastolic blood pressure. When the device detects an irregular rhythm two or more times during the measurement, the Irregular Heartbeat Symbol will be displayed with the measurement values.
2. Know Your Device
DIAGRAM
Display
[ START ] Button
Wrist Cuff
[ STOP ] Button
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3. Instruction For Use
3.1 Before Taking a Measurement
• For most accurate results, measurements should be taken in the same circumstances and at the same time every day.
• The unit can be applied to either wrist, but preferably the left. Use the same wrist for each measurement.
• Any blood pressure recording can be affected by the position and physiological condition of the subject, as well as other factors such as background noise, stress, talking and body movement etc.
• Avoid taking measurements while under stress.
• Do not eat, drink alcohol, smoke, exercise, or bathe 30 minutes before using the unit, as
these activities may change blood pressure.
• For an accurate indication of true blood pressure, take and record several measurements over a period of time.
• If consecutive measurements are desired, allow two minutes between uses to allow blood to flow through the arm normally.
• This device is used to monitor blood pressure. However, it cannot treat or prevent high blood pressure. If you suffer from high blood pressure, consult your doctor.
3.2 Take a Measurement
1. Ensure that the device should be used on bare skin. Remove wristwatches or other jewelry. If necessary, loosely roll up your sleeve to expose wrist.
2. With screen aligned to the midline of the back
of the hand, wrap and fasten the watchband with cuff around your wrist properly, not too tightly or too loose.
USB Port
only for charge
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3. Comfortably seated
Legs uncrossed
Feet flat on the floor
Back and arm supported,
Keep the device at the same level as your heart.
Relax as much as possible and not talk during the measurement.
4. While sitting upright in a chair with your feet flat on the floor, press “START ". Symbols
on screen will increase and cuff will begin to inflate. Do not move, activate arm
muscles, or talk during measurement.
5. Measurement can be stopped at any time by pressing “STOP".
6. When the unit senses a pulse, a heart symbol will flash on screen.
7. When measurement is complete, the cuff deflates automatically and the systolic, diastolic, and pulse rate will display on screen.
8. Turn off the device by pressing “STOP".
4. Cleaning and Maintenance
• For regular maintenance, the device only needs to be wiped gently with a soft, dry cloth while it is not being used. Never immerse the device or any components in water.
• Do not carry out repairs of any kind yourself. If a defect occurs, please contact your local
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authorized distributor. Use only authorized parts and accessories.
5. Troubleshooting
If you see any of these symbols displayed on screen, perform the corresponding correction:
6. EMC Declaration
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity the device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment.
Immunity Test
Compliance
Electromagnetic Environment - Guidance
RF emissions CISPR 11
Group 1
The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Symbol
Cause
Correction
wearing loose
wearing inappropriate
Not with the cuff.
Wrap the cuff right too loose.
body motion interference
Measuring equipment turbulence
Do not move your arm and body, and keep quiet.
wearing tight
The ring sleeve is worn tight
Wrap the cuff right too loose.
Bluetooth connection modes
Please connect to the APP device
When the batteries power are too low.
Please charge in time.
charging mode
In the process of charging
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RF emissions CISPR 11
Class B
The device is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions IEC 61000-3-2
Not applicable
Voltage fluctuations/ Flicker emissions IEC 61000-3-3
Not applicable 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%
Power frequency (50Hz/60Hz) magnetic field IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Magnetic fields from common appliances are not expected to affect the device.
NOTE: UT is the a.c. mains voltage prior to application of the test level
Radiated RF IEC 61000-4-3
10V/m 80MHz to
2.7GHz
9V/m, 27V/m, 28V/m 385-5785 MHz
10V/m 80MHz to
2.7GHz
9V/m, 27V/m, 28V/m 385-5785 MHz
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 device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
7. FCC Compliance
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.
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Caution: Changes or modifications to this device not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance to 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 to 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.
8. Specifications
Model No.
BPW1
Display
LCD display
Measuring Principle
Oscillometric Method
Measurable Circumference of Wrist
13.5~21.5cm(5.3''~8.5'')
Electric Shock Protection
Internal power supply appliance type BF
Measurement Range
Pressure
0 to 299 mmHg
Pulse
40 to180 Pulses/min
Accuracy
Pressure
±3 mmHg
Pulse
±5% of reading
LCD Indication
Pressure
3 Digits Display of mmHg
Pulse
3 Digits Display
Inflation
Automatic by Internal Pump
Rapid Air Release
Automatic by Air Valve
Power Source
Built-in 3.7V-210mAh Li-ion Polymer Battery which should be charged by a charger of 5V/500mA or more
USB
USB 2.0 Port only for battery charge
Bluetooth
Bluetooth 4.0(data transmission), Frequency range:2.4GHz(2402 – 2480MHz),Modulation: GFSK, Effective radiated power:
-5dBm+/- 1dB
Stand-by time
Within 2 Minutes
Gross Weight
Approx. 67g
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Device Life
2 Years
Operating Environment
Temperature
10~40(50 ~ 104 )
Humidity
15 ~ 90%RH (Noncondensing)
Barometric Pressure
80~106 kPa
Transport Storage Environment
Temperature
-20~55(-4 ~ 131)
Humidity
0 ~ 90% RH (Noncondensing)
Note: Subject to technical modification without prior notice.
To improve performance, these specifications are subject to change without notice.
Disposal of the device, accessories and packaging shall be carried out in accordance with national and local regulations for proper handling of waste.
9. Calibration and Service
The accuracy of this blood pressure monitor has been carefully tested and is designed for a long service life. It is generally recommended to have the device inspected and calibrated every two years to ensure correct functioning and accuracy. Please consult you authorized distributor, or refer to www. The device Support.com If the equipment failure analysis, maintenance please send your authorized distributors.
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10. Warranty Information
■ The device is warrantied to be free of manufacturing defects in workmanship and
materials for a period of one year from the date listed on the purchase record, when used in accordance with the instructions provided with the device.
■ This warranty does not cover damage incurred by use of the device not in accordance
with the instructions, accidental damage, or being tampered with or serviced by unauthorized service agents.
■ For repair of manufacturing defect under this warranty, please contact your local distributor within the period of the warranty. This warranty covers parts and labor only under normal operations. A transportation fee or freight fee that may be incurred will be the owner’s responsibility. Any defect resulting from natural causes, e.g., flood, hurricane etc., is not within this guarantee.
■ Please note warranty does not cover damage caused by, including but not limited to:
misuse or abuse; accident; the attachment of any unauthorized accessory; alteration to the product; improper installation; unauthorized repair or modification; improper use of electrical/power supply; dropped product; failure to follow required maintenance and safe-keeping; transportation damage. This warranty specifically excludes expendables and consumables, for example batteries. All warranty claims must be directed to the distributor responsible for the sale of the device. The content of this warranty is subject to change without further notice. The device complies with IEC 60601-1:2005+A1:2012, IEC
60601-1-22014, IEC 60601-1-11:2015, IEC 80601-2-30:2009+A1:2013, EN 1060-3: 1995+A2:2009
Note: To ensure accuracy, calibration by qualified technician is recommended every two years or after a repair. Please contact your authorized distributor for details
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11. Symbols Use
SYMBOLS USED IN THIS INSTRUCTION MANUAL
WARNING
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property.
AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY
Transport Package shall be kept away from rain.
Refer to instruction manual/booklet MANUFACTURER
Type BF applied part
SERIAL NUMBER
The marking of electrical and electronics devices according to Directive 2002/96/EC. The device, accessories and the packaging have to be disposed of waste correctly at the end of the usage.
IP22
Moisture Protection
Bulletin board number of Germany lane
European representative name: Shanghai International Holding Corp. GmbH (Europe) Address: Eiffestrasse 80, 20537 Hamburg Germany
Shenzhen Kingyield Technology Co., Ltd. Section C1-2 FuHai lndustrial Zone Fuhai Road Fuyong Town
Bao’an District, Shenzhen City Guangdong, 518103 CHINA
Website: http://www.kingyield.com
VER: A00
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