Shenzhen Finicare FC-BP100 Upper Arm Electronic Blood Pressure Monitor Instruction Manual

June 8, 2024
Shenzhen Finicare

Shenzhen Finicare FC-BP100 Upper Arm Electronic Blood Pressure Monitor

Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-Monitor-
PRODUCT

  • Manual Ver.: 1.0
  • Software Ver.: FC-BP100-V1.0
  • Issuing Date: 2021/09/28

Please read this instruction manual carefully before using your unit. Please keep this instruction manual well for future use. Thanks for choosing the Digital Blood Pressure Monitor. The PATIENT is an intended OPERATOR.

Before Using the Unit

Introduction

  • Thank you for purchasing Upper Arm Electronic Blood Pressure Monitor.
  • The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.
  • The unit stores automatically 2*90 sets of measurement values. You can read the stored data conveniently by pressing the memory button.
  • The unit comes with the following components:
    • Main Unit
    • Arm Cuff
    • Instruction Manual printed in English

SYMBOLS USED IN THIS INSTRUCTION MANUAL

  • Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
  • 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.
  • Please read this instruction manual thoroughly before using the unit. Please keep for future reference. For specific information about your own blood pressure, CONSULT YOUR DOCTOR.
  • Transport package shall be kept away from rain.
  • AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY
  • Refer to instruction manual/booklet
  • MANUFACTURER
  • SERIAL NUMBER
  • Type BF applied part
  • 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. Please follow Local Ordinances or Regulations for disposal.
  • Device used within the Magnetic Resonance (MR) environment is prohibited.

Important safety notices
To assure the correct use of the product basic safety measures should always be followed including the precautions listed as below:

  • Please read all information in the instruction manual and any other literature included in the box before using the unit.
  • Please contact your physician for specific information about your blood pressure. Self-diagnosis and treatment by measure results may be dangerous. Follow the instructions of your health care provider.
  • Operate the unit only as intended. Don’t use for any other purpose. The unit is intended to use in measuring blood pressure and pulse rate for adult only, not recommended using for neonatal baby at home or medical centre.
  • Do not use a cellular phone near the unit. It may result in operational failure.
  • Please avoid using in high radiant area in order to make your measuring data correctly.
  • Do not disassemble or attempt to repair the unit or components. Do not use the equipment in places where there are flammable gas (such as anesthetic gas, oxygen or hydrogen) or flammable liquid (such as alcohol) .
  • Do not use a mobile phone or other devices that emit electromagnetic fields near the unit. This may result in incorrect operation of the unit.
  • Indicating that too frequent measurements can cause injury to the PATIENT due to blood flow interference;
  • Please remove the batteries if the unit will not be used for Three months or More.
  • Please do not put CUFF over a wound, as this can cause further injury;
  • Regarding the effect of blood flow interference and resulting harmful injury to the PATIENT caused by continuous CUFF pressure due to connection tubing kinking;
  • Statement:Regarding the requirements of the adapter, it should meet the following conditions, output voltage: DC 5V, Current: 1000mA, and comply with IEC 60601-1 and IEC 60601-1-11, provide two MOPP insulation between ac input and dc output.
  • Do not install the wrong battery polarity.
  • After the battery is exhausted, please replace four new batteries.
  • If over three months do not use the device, please remove the battery as it may cause leakage, overheat, rupture and damage the blood pressure monitor body.

Warning and safety notices

  • Regarding the application of the CUFF and its pressurization on any limb where vascular access or therapy, or an arteriole-venous (A-V) shunt, is present because of temporary interference to blood flow and could result in injury to the PATIENT;

  • Regarding the application of the CUFF and its pressurization on the arm on the side of a mastectomy;

  • Pressurization of the CUFF can temporarily cause loss of function simultaneously used monitoring ME EQUIPMENT on the same limb;

  • Regarding the need to check (for example, by observation of the limb concerned) that operation of the AUTOMATED Blood Pressure Monitor does not result in prolonged impairment of the circulation of the blood of the PATIENT.

  • When the arm is oppressed by air pressure, please loosen CUFF or remove batteries.

  • Please do not touch the patient and battery output simultaneously when measurement.

  • Warning: Do not allow to use the lure connectors. If lure lock connectors be used in the construction of tubing, there is a risk that they might be inadvertently connected to vascular fluid systems and allowing air to be pumped into a blood vessel.

  • Warning:Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Blood Pressure Monitor, including cables specified by the manufacturer. Otherwise, degradation
    of the performance of this equipment could result.

  • Warning:The Blood Pressure Monitor is placed in the position not touched by pets, pests or children. Warning:The neck of a child or animal is strangled due to the too long air hose, which is a threat to life, etc.;

  • Warning:The hazard of accidental ingestion due to the small parts that can be disassembled (such as batteries, etc.) after being touched by a child; Place the product out of the reach of children, etc.; use it under the supervision of an adult, etc.;

Operating Instruction

Know your unit BodyShenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-
Pressure-Monitor-FIG-1

Display

Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-Monitor-
FIG-2

Arm Cuff

Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-Monitor-
FIG-3

  • If your arm cuff is broken or not functional, please use a new cuff.
  • new arm cuff does not include an air plug. Please continue to use the old air plug on the new arm cuff.

Power

  • 4 AA Alkaline Batteries
  • Do not use rechargeable batteries.

Instruction Manual

  • Please keep the instruction manual well after using.

Battery Installation / Replacement

  1. Remove the battery covers from the battery compartment.
  2. Install 4 “AA” size batteries to match the + (positive) and – (negative) polarities with the polarities of the battery compartment as indicated.
  3. Replace the battery cover.Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-Monitor-FIG-5

Caution!

  • Replace both of the batteries if the symbol of low battery appears on the display.
  • Never leave any low battery in the battery compartment since they may leak and cause damage to the unit.

Settings

To set year
Long press the “ SET ” button when power off, you can see the year icon appears and flashes, then press the “ MEM ” to increase one year, long press the button and the value quickly changes.Shenzhen-Finicare-FC-BP100-Upper-
Arm-Electronic-Blood-Pressure-Monitor-FIG-6

To set date and time
Based on first step and press “ SET ” button again. The mark of month and date appears and flashes, press the “ MEM ” button to change the month and press the “ SET ” button to cotinue with next step. Then set the day, the hour and the minute by using the same way.Shenzhen-Finicare-FC-BP100-Upper-Arm-
Electronic-Blood-Pressure-Monitor-FIG-7Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-
Blood-Pressure-Monitor-FIG-8

To set 12 or 24 hours
Based on the second step and press the “ SET ” button, the “12 hours” appears and flashes, then press the “ MEM ” button to switch into “24 hours”.
Presss the “ start/stop ” button to confirm the current setting.Shenzhen-
Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-Monitor-
FIG-9

To set unit
Based on the third step and press the “SET” button to change the previous unit(kPa or mmHg), the mark “ ” appears and flashes, now the BPM is in mmHg status, and then press the “MEM” button, to change it into “ ”, now the BPM is in kPa status. Presss the “ start/stop ” button to confirm the current setting .Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-Monitor-
FIG-10

To set voice
Based on forth step, press the “SET” button again to adjust the sound “ SET ” or” ” page. When the “5nd on ” appears and flashes, press “ MEM ” button to change it. when the screen shows “5nd off ” , Blood Pressure Monitor sound is on; when the screen shows”5nd off “, Blood Pressure Monitor sound is off. Press “START/STOP” button to save the current setting and turn off .Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-Monitor-
FIG-11

To set user
Press the “ USER ” button when power off, and the press the “ USER ” button again to swich User 1 or User 2.Shenzhen-Finicare-FC-BP100-Upper-Arm-
Electronic-Blood-Pressure-Monitor-FIG-12

The operation of setting can be stopped at any time by pressing “START/STOP” button.

Proper Use of the Arm Cuff

Make sure the air plug is inserted properly in the main unit.Shenzhen-
Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-Monitor-
FIG-13

  1. Remove all clothes from your upper arm allowing the cuff to fit directly on the skin.

  2. Sit in a chair with your feet flat on the floor. Place your arm on a table so as to level the cuff to your heart.

  3. Pass the end of the cuff through the metal, and keep the hose outward.Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-Monitor-FIG-16

  4. Put your arm through the loop, then pull it up to the position of your upper arm.Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-Monitor-FIG-17

  5. The hose runs down the inside of your arm. The bottom of the cuff should be approximately 1~2cm above your elbow.

  6. Wrap the cuff tightly around your upper arm by using the Velcro strip. Do not leave any spacing between the arm and the cuff.

  7. Relax your arm, keep the palm upward and the fingers curving naturally, then turn on the unit and start to measure.

  8. The device has the WHO warning strip “ ” symbol display function, with the blood pressure value change, the higher blood pressure value “ ” symbol will appear relatively in the higher position (refer to WHO definition of high blood pressure levels-reference table).

  9. The device has the average of the last three display function (press the memory key for the first time to display the value that is the average of the last three measurements).

  10. The device has a large screen display and digital legible.

  11. The device has kPa and mmHg display switching and measurement functions.

  12. The device has double memory lookup function and can store 90 set of measurements for each person to remember the normal status of your blood pressure.

  13. Clock function: year, month, day, hour, minute setting.

  14. Low power detection: detecting low power under any working state, LCD displays “ ” symbol indicates low power.

  15. Overpressure protection function: when the pressure is more than 300mmHg, the device will exhaust fast automatically.

  16. Automatic shutdown function: no operation for 1 minute the device will shut down automatically.

  17. Heartbeat prompting voice.

  18. Measurement completed prompting voice.

  19. Incorrect prompting function.

RATED ranges of the DETERMINATION:

  • Cuff pressure: 0-299 mmHg
  • SYS: 45-255 mmHg
  • DIA: 24-216 mmHg

Take a Measurement

Press the “START/ STOP” button.
All display symbols appear on the screen. The cuff starts to inflate automatically.Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-
Pressure-Monitor-FIG-22

Measurement start. When pressurized to stop blood flow, the Blood Pressure Monitor stops pressure before automatically leaking air and automatically measuring blood pressure. The heartbeat symbol flashes once a pulse is detected. When the heart beat symbol appears and flashes, the Blood Pressure Monitor detects the pulse and begins to calculate the pulse automatically .Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-Monitor-
FIG-23

The blood pressure and pulse rate are displayed when the measurement completed. The cuff is deflated automatically, and all of the measurement results be stored in the memory with date and time. The symbol will be displayed if irregular heartbeat is detected.

Press the “START/ STOP” button to turn off the unit.
The unit will automatically turn off after two minutes if no more operation.

NOTE: The inflation or measurement can be stopped by pressing the “START/ STOP” button at any time.

Use the Memory function
The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2×90 sets of measurement values can be stored automatically. The earliest record will be deleted automatically to save the latest measurement value when more than 2×90 sets. The unit also calculates an average reading based on the values of the latest 3 times measurement .

To enter the memory mode & to read the average value
Press the “MEM” button while the unit is off, the unit enters the memory mode and the average value of the latest 3 times measurement values of the current user will be displayed.Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-
Blood-Pressure-Monitor-FIG-25

To read the measurement value
Press the “MEM” button when power off, the latest measurement values with the measuring month, date and time will be displayed. Press the “MEM” button once more, the measurement values before the latest will be displayed, and so on .Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-Monitor-
FIG-26

To delete the memory value

  • In the memory mode, long press the “MEM” button, the unit displays the following symbol to cancel all the memory records of the current user.
  • Please opreate the delete memory function cautiously.
  • Press the “ START/STOP ” to cancel the memory records of the current user if you are sure all the data of corresponding user can be deleted, the unit will turn off after deleting.Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-Monitor-FIG-27

About Blood Pressure

Irregular Heartbeat Symbol IHB
When the unit detects an irregular rhythm two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values. An irregular heartbeat rhythm is defined as a rhythm that is more than 25% slower or 25% faster from the average rhythm which detected while the monitor is measuring the systolic blood pressure and the diastolic blood pressure. If the Irregular Heartbeat Symbol displays with your measurement results, we recommend you consult your physician, and follow the doctor’s directions. Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-
Pressure-Monitor-FIG-28

Blood Circulation
The blood circulation is responsible for supplying the body with oxygen. Blood pressure is the pressure exerted on the arteries. The systolic blood pressure value (higher pressure or top value) represents the blood pressure produced by contraction of the heart muscle. The diastolic blood pressure value (lower pressure or lower value) represents the blood pressure produced by relaxation of the heart muscle.Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-
Pressure-Monitor-FIG-29

Health and Blood Pressure
The incidence of hypertension increases with age. In addition, if lack of exercise, excess body fat and high levels of cholesterol(LDL), would sticks to the inside of blood vessels, which reduces elastictity of these vessels. Hypertension accelerated arteriosclerosis which can lead to serious conditions such as stroke and myocardial infarction. For these reasons it is very important to know whether the blood pressure is within a healthy range. Blood pressure fluctuates from minute to minute, throughout the day. Therefore it is essential to take regular measurements to help you identify an average blood pressure.Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-
Monitor-FIG-30

About Blood Pressure

Classification of Blood Pressure
After each measurement is completed, the LCD display will show your position automatically on the six segments of the bar indicator which corresponds to World Health Organization (WHO) Blood Pressure Indicator.

Reference Material: Journal of Hypertension 1999, Vol 17 No.2Shenzhen-
Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-Monitor-
FIG-31

Note!
When a person’s systolic and diastolic pressures fall into different categories, the higher category should apply.

Symptoms of High Blood Pressure
High blood pressure can go unnoticed for a long time, since it doesn’t cause noticeable symptoms. The following are possible causes of abnormally high blood pressure:

  • Overweight;
  • High cholesterol level;
  • Smoking;
  • Excessive alcohol consumption;
  • Stress and emotional upset;
  • Excessive consumption of salt;
  • Lack of physical exercise;
  • Genetic / hereditary predisposition;
  • Underlying illnesses, such as kidney disorders or endocrine disturbance.

Treatment of High Blood Pressure
If your blood pressure reaches upper values of 140~160 mmHg and lower values of 90~95 mmHg in repeated measurements over several days, you
should consult doctor for detailed medical examination. You can assist the treatment prescribed by your doctor in the following ways:

  • Loose weight and lower your cholesterol level;
  • Reduce the consumption of alcohol;
  • Reduce the intake of salt;
  • Stop smoking;
  • Take regular exercise;
  • Monitor your blood pressure.

Care and Maintenance

Care and Maintenance
To keep your blood pressure monitor in the best condition and protect the unit from damage, please follow the directions listed below:

  1. Clean the unit with a soft dry cloth. Do not use any abrasive or volatile cleaners. Do not attempt to clean the cuff. Never immerse the unit or any components in water.

  2. Store the unit in a safe and dry location. Do not fold the cuff too tight. Do not subject the unit to extreme hot or cold temperatures/humidity and do not subject the unit under the direct sunlight.

  3. Avoid subjecting the unit to strong shocks, such as dropping the unit on the floor.

  4. Remove the batteries if the unit will not be used for three months or longer. Always replace all the batteries with new ones at the same time.
    Use the unit consistent with the instruction provided in this manual. Use only authorized parts and accessories.

  5. Do not carry out repairs of any kind yourself. If a defect occurs, Please contact the local distributor.

  6. We will provide circuit diagrams, component part lists, descriptions, calibration instructions, or other information to assist service personnel who is trained by the manufacturer and has got the relevant qualification certificate.

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 unit inspected every two years to ensure correct functioning and accuracy. Please consult local authorized distributor or dealer.

Error Indicators
The following symbols will appear on the display when measuring abnormally .Shenzhen-Finicare-FC-BP100-Upper-Arm-Electronic-Blood-Pressure-Monitor-
FIG-32

Troubleshooting

Problem Causes and Solutions
No power Replace all of the worn batteries with new ones

No display appears on the display screen

| Check the battery installation for proper placement of the batteries polarities

Measurement values appear too high or too low

| Blood pressure varies constantly. Many factors may effect your blood pressure, including stress, time of day, how you wrap the cuff. Review the sections “Proper Way of Measurement” and “Take a Measurement”

Technical Data

Specifications

1 Model FC-BP100
2 Measurement Method Oscillographic measurement method
3 Display LCD Digital Display
4 Wireless transmission Bluetooth BLE4.2 module
5 Measurement Range Blood Pressure range: 0~299mmHg (0 kPa – 39.9 kPa)

Pulse: 40 to 180 beats/min

6

|

Accuracy

| Static Pressure: ±3mmHg(±0.4 kPa) Pulse rate: Within ±5% of reading
7| Inflation| Automatic inflation by pump
8| Deflation| Automatic rapid deflation
9| Pressure Detection| Semiconductor pressure sensor
10| Memory| 2 persons * 90 memories

11

|

Power supply

| 4 AA alkaline batteries ( not included ), DC6V
USB Type C(DC5V1A)

12

|

Battery life

| Approximately 300 measurements when using alkaline batteries at the room temperature of 22°C and by using three times a day and inflating to

170 mmHg

13

|

Storage Temperature

| Temperature: -4°F to 140°F (-20°C to 55°C) Humidity: 0 to 95% RH

Atmospheric pressure: 70 – 106kPa

14| Operating Temperature| Temperature: 50°F to 104°F (10°C to 40°C) Humidity: 15 to 85% RH
15| Automatic Power-OFF| Within 2 Minutes
16| Weight of Main Unit| 298g
17| External Dimensions| 11014465mm
18| Cuff| Soft Arm Cuff
19| Electric Shock Protection| Internal power supply appliance type B
20| Accessorial Components| Cuff, Instruction Manual
21| Device Life| 5 Years

To improve performance, these specifications are subject to change without notice. The device, accessories and the packaging have to disposed waste correctly after the end of the usage, so that the risk of patient or user can be lowered to acceptable level.

Statement

  • The unit is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the upper arm by using the oscillometric method.
  • The unit is intended for using in only adult population, not applied to the other populations such as neonatal baby
  • It can’t be used while the wirst (arm) has bleeding or wound to avoid the blood flowing from the wound when pressurzing.
  • The device’s accessories and batteries have to be disposed of waste correctly at the end of the usage, please follow Local Ordinances or Regulations for disposal.
  • Applied part: CUFF.
    • Protection Class: Internally powered equipment.
  • Applied Part Type: Type BF.
    • Moisture Protection: IP20, continue operation. Altitude<2000m;
    • Overvoltage:II;
    • Pollution degree:2
  • The risk of patient and user can be lowered to acceptable level.
  • The unit might not meet its performance specification if stored or used outside the following specified temperature , humidity and altitude ranges.
  • The unit satisfies the requirements of IEC60601-1 Medical electrical equipment, IEC 60601-1-2: Electromagnetic compatibility –Requirements and tests IEC 80601-2-30: Non-invasive sphygmomanometers – Part 1: Requirements and test methods for non-automated measurement type EN1060-3: Non-invasive sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems.

IEC 60601-1-2 :2014 ME EQUIPMENT and ME SYSTEMS identification, marking and documents for Class B product The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments and so on.

  • Warning:Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
  • Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
  • Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.”
  • Warning:Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Upper Arm Electronic Blood Pressure Monitor (M/N: FC-BP100), including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • If any: a list of all cables and maximum lengths of cables (if applicable), transducers and other ACCESSORIES that are replaceable by the RESPONSIBLE ORGANIZATION and that are likely to affect compliance of the ME EQUIPMENT or ME SYSTEM with the requirements of Clause 7 (EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES may be specified either generically (e.g. shielded cable, load impedance) or specifically (e.g. by MANUFACTURER and EQUIPMENT OR TYPE REFERENCE).
  • If any: the performance of the ME EQUIPMENT or ME SYSTEM that was determined to be ESSENTIAL PERFORMANCE and a description of what the OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES (the defined term “ESSENTIAL PERFORMANCE” need not be used).

Technical description

  1. all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
  2. Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity Table 1
    Guidance and manufacturer’s declaration – electromagnetic emissions

    Emissions test| Compliance
    RF emissions CISPR 11| Group 1
    RF emissions CISPR 11| Class B
    Harmonic emissions IEC 61000-3-2| Class A
    Voltage fluctuations/ flicker emissions

IEC 61000-3-3

|

Compliance

Table 2

Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test| IEC 60601-1-2 Test level| Compliance level
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

Electrical fast transient/burst IEC 61000-4-4| Power supply lines:±2 kV 100 kHz repetition frequency| Power supply lines:±2 kV 100 kHz repetition frequency
Surge IEC 61000-4-5| line(s) to line(s):±1 kV.| line(s) to line(s):±1 kV.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| 0% 0.5 cycle At 0º, 45 º, 90 º,

135 º, 180 º, 225 º, 270 º and

315 º 0% 1 cycle And 70% 25/30 cycles Single phase: at 0 0% 300 cycle

| 0% 0.5 cycle At 0º, 45 º, 90 º,

135 º, 180 º, 225 º, 270 º and

315 º 0% 1 cycle And 70% 25/30 cycles Single phase: at 0 0% 300 cycle

Power frequency magnetic

field IEC 61000-4-8

| 30 A/m

50Hz/60Hz

| 30 A/m

50Hz/60Hz

Conduced RF IEC61000-4-6| 150KHz to 80MHz:3Vrms 6Vrms (in ISM and amateur

radio bands)80% Am at 1kHz

| 150KHz to 80MHz:3Vrms 6Vrms (in ISM and amateur

radio bands) 80% Am at 1kHz

Radiated RF IEC61000-4-3| 10 V/m 80 MHz – 2,7 GHz

80 % AM at 1 kHz

| 10 V/m 80 MHz – 2,7 GHz

80 % AM at 1 kHz

---|---|---
NOTE UT is the a.c. mians voltage prior to application of the test level.

Table 3

Guidance and manufacturer’s declaration – electromagnetic Immunity

Radiated RF IEC61000-4-3

(Test specifications for ENCLOSURE PORT IMMUNITY

to RF wireless communications equipment)

| Test Frequency (MHz)|

Band (MHz)

|

Service

|

Modulation

|

Maximum Power(W)

|

Distance (m)

| IEC 60601-1-2

Test level

(V/m)

|

Compliance level (V/m)

385

| 380 –

390

| TETRA 400| Pulse modulation

18 Hz

|

1,8

|

0,3

|

27

|

27

450

|

430–

470

| GMRS 460,

FRS 460

| FM

± 5 kHz deviation 1 kHz sine

|

2

|

0,3

|

28

|

28

710| 704 –

787

| LTE

Band 13,17

| Pulse modulation

217 Hz

|

0,2

|

0,3

|

9

|

9

745
780

810

|

800 –

960

| GSM 800/

900, TETRA 800, iDEN 820, CDMA 850, LTE

Band 5

|

Pulse modulation 18 Hz

|

2

|

0,3

|

28

|

28

870

930

 | 1720|

1700 –

1990

| GSM 1800;

CDMA 1900;

GSM 1900; DECT;

LTE Band 1, 3,4,

25; UMTS

|

Pulse modulation 217 Hz

|

2

|

0,3

|

28

|

28

---|---|---|---|---|---|---|---|---
1845
1970

2450

|

2400 –

2570

| Bluetooth, WLAN,

802.11 b/g/n, RFID 2450,

LTE Band 7

|

Pulse modulation 217 Hz

|

2

|

0,3

|

28

|

28

5240| 5100 –

5800

| WLAN 802.11

a/n

| Pulse

modulation 217 Hz

|

0,2

|

0,3

|

9

|

9

5500
5785

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.

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 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.

MODIFICATION: Any changes or modifications not expressly approved by the grantee of this device could void the user’s authority to operate the device. Changes or modifications to the product not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

State

Bluetooth connection and transmission function: search for “Device name XXX” to open the APP, turn on the blood pressure monitor, turn on the Bluetooth, connect to the Bluetooth, and start data transmission. The blood pressure monitor is turned off and Bluetooth is turned off.

Warranty Information

  • The unit, excluding the unit cuff, is guaranteed to be free of defects in workmanship and materials for a period of two years from the date listed on the purchase record, when used in accordance with the instructions provided with the unit. The unit cuff is warranted to be free from defects in materials and workmanship appearing within one year from the date listed on the purchase record when the unit is used in accordance with the instructions provided with the unit.

  • This guarantee does not cover damage incurred by using without following in accordance with the instructions, accidental damage, or being tampered/serviced by unauthorized service agents.

  • For repair under this warranty. Our authorized service agent must be advised of the fault 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.

  • Unit subjected to misuse, abuse, and neglect of these manual contents, non-instructional purposes, and unauthorized repair or modifications will be excluded from this warranty.
    This guarantee 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.

  • WARNING: No modification of this equipment is allowed.

Indication for Use
Upper Arm Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices’ features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected. The devices’ feature includes Bluetooth function to transmit data to an external Bluetooth device with wireless communication.

Considerations for measuring

  1. The correct using method
  2. Elbow on the table;comfortably seated;legs uncrossed;back and arm supported;
  3. Keep the center of the cuff and the heart or nipples at the same height.
  4. Do not put the clothes into the cuff.
  5. Palms up, body keep relaxed.
  6. Sitting in a chair keep your foot flat on the ground. house is 20-35cm A recommendation that the PATIENT relax as much as possible and not talk during the measurement PROCEDURE;a recommendation that 5 min elapses before the first reading is taken;need to avoid compression or restriction of the connection tubing.
  7. Ideal environment for measuring blood pressure
  8. Get up in the morning, when the mood is relaxed.
  9. No consciousness to the toilet
  10. Room temperature is about 20℃
  11. Aquiet place and there was no noise around.
  12. Measure blood pressure at the same time every day: Blood pressure is constantly changing and cannot judge the situation only by the result of once blood pressure measurement, according to a period of time, repeated measurements to determine blood pressure condition is more reliable So please stick to measure blood pressure every day, select the mood in a day can keep the most stable state period such as early in the morning after getting up. Ideal method is to measure as far as possible at the same time every day.
    Note: be sure to have more than 2-3-minute interval between two measurements.
    Depending on your individual physiological characteristics, between the two measurements may need to rest for a longer time. Please keep the wristband around the wrist before you start measuring. Do not measure your blood pressure on bus.

U.S.Agent ABMED SERVICE INC 1312 17th Street Suite 692 Denver, CO US 80202 Tel: 303 8000162 E-mail: info@abmed.com.cn Manufacturer: Shenzhen Finicare Co., Ltd 201, No.50, the 3rd Industrial Park, Houting Community, Shajing Street, Bao’an District, Shenzhen 518104 China FCC ID: 2A3QXFCBP100 Website: https://www.finicare.com/ Made in China

References

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