FAMIDOC FDBP-A10BL Upper Arm Blood Pressure Monitor User Manual

FAMIDOC FDBP-A10BL Upper Arm Blood Pressure Monitor

USER MANUAL
Subject to our actual product

• Thanks for using our product.
• Take care of this instruction manual.
• Please read this manual carefully before using.

Precaution:
Please read the instruction manual carefully before use it. If you have any questions, please consult the salesperson in the purchasing center or ask your doctor.
FCC ID:PONFDBP

Warnings and Precautions

 Warning

•  This product is not suitable for newborns.
• This product is for home use only. When the measurement is complete, consult your doctor if you have any doubts about the measurement result .Do not self-diagnosis and treatment according to measurement results.
• When common arrhythmia (such as atria premature beats, premature ventricular and atrial fibrillation) occurs, it will affect the measurement accuracy of blood pressure. If it is only sporadic, please take a rest for two hours before measuring. If it is a frequent nature, please go to the hospital for confirmation and treatment immediately.
• If the airbag is inflated for a long time, immediately press the [START/STOP] button to stop the measurement. Continued inflation presses the hand arm, which can cause limb numbness.
•  Do not allow children to use the instrument without authorization: Some small parts may cause ingestion.
•  It is forbidden to measure blood pressure on the side where the breast is removed.
• Do not allow children to use instruments without permission: Small parts can cause the risk of ingestion. Hose may cause choking hazard.
• Do not allow service and maintain the product while in use
• Do not allow use the product while in charging
• In order to avoid bacterial cross-infection, the product alone is recommended
• pressurization of the CUFF can temporarily cause loss of function of simultaneously used monitoring ME EQUIPMENT on the same limb;
• do not used together with HF SURGICAL EQUIPMENT

 Precautions

•  Avoid high temperature, humidity, dust and direct sunlight.

•  Avoid damage to the arm band and rubber tube due to folding

• Do not disassemble this unit yourself! Otherwise it will cause the manufacturer’s school pressure calibration to fail!

• Avoid falling or violently vibrating the body.

• The normal measurement period is about 1 minute. If the measurement is not stopped for a long time, please press the [START/STOP] button to stop the measurement. Avoid numbness of the limbs due to prolonged compression of the arm.

• Original or medically compliant power adapters (eg iec 60601-1 certified) must be used, and non-original
  accessories may present unpredictable risks.

• For better reading of the display, please note the following visible conditions: – Ambient brightness: 100lx~1500lx – Line of sight: less than 30cm – Viewing angle: normal display ± 30 °

• Extreme temperature, humidity, and altitude conditions can affect the performance of the measurement, and the Upper Arm Blood Pressure Monitor may not meet the stated performance specifications.

• Do not put the cuff on the wound, which will cause further damage.

• Do not measure blood pressure if there is intravascular access or treatment, or arteriovenous (A-V) shunt.

Purpose/intended use of device

Upper Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adults and children at least 12 years of age,  household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia). with the cuff around the
left upper arm according to the instruction in the user’s guide manual. the patient is an intended operator Intended operator should receive at least 8 years of education so that can read and understand the user manual

Product Features

The FDBP-A10BL is an Upper Arm Blood Pressure Monitor that simultaneously measure systolic, diastolic blood pressure and pulse rate through the principle of pressure oscillation.Not only its accuracy reaches the medical grade, but also suitable for home health care. In addition, the humanized design provides users with the greatest convenience.

Self -Measurement

•  Please keep in mind :self-measurement is equal to self control, not diagnosis or treatment. If you have abnormal blood pressure, should consult physician immediately and follow physician’s instructions to take medicine.
• The pulse displayed by this unit is not suitable to be a fixed frequency detector that identify heart rate! Those who have a history of  heavier arrhythmia, should consult a professional physician about measured blood pressure value and confirm.

Electromagnetic Interference

Due to the unit has sensitive electronic components, avoid using it directly in strong electromagnetic environment (such as: mobile phone, microwave oven etc.), as it may lead to inaccurate results.

Unpacking

Unpack the box and lay the product flat on the table.

Note If you bring the product from a storage environment, place it in a normal use environment for 20 minutes

Battery

If there is a signal of low power on the display, connect your charger

• Icon lit: Battery is low.
• Lo icon lights up: battery is exhausted.
• Please connect adapter to charge.
• Do not use this product while charging. No measurement function during charging

Please pay attention!
Once the signal of low power is displayed, the product will not be used unless you charge it.
Note:

• Consult the dealer at the place of purchase for any adapter problems.

Use adapter

Except the battery, this unit can also use a adapter (USB 5V).Must use the original or medical power supplies that meet medical standards.
(example: IEC 60601-1 certification). Transformer connects to power socket is shown on the following. Adaptor connects to the power socket of the product and press the START/STOP/memory button to test if it is power.

If power failure suddenly during measurement (for example, adapter plug is disconnected to power outlet), adapter single-pin plug should be unplugged and reinsert into the unit again.
Any problems about adapter, please consult purchased dealer locally.

The correct method of using the cuff

Insert the air tube plug into the air tube connector

• Make sure the arm strap connector is fully inserted into the Upper Arm Blood Pressure Monitor vent.

•  Please take off your coat, sweater and other thicker clothes, do not have any accessories, bare upper arm or wear a thin shirt for measurement.

• Wrap the cuff around the left arm.

•  Do not wrap the cuff too tightly (It is the best to easily insert a finger) and the lower edge of the cuff should be 2~3 cm from the hand bend (as shown).

• After wrapping the cuff around the upper arm, place the air tube on the inside of the arm and on the same line as the middle finger (as shown).

• When measuring, please sit in the chair, place your feet flat on the floor, place your arms on the table, and put the arms and the heart on the same level to relax and measure in a relaxed and natural posture.

Preparation before measurement

For wireless features, see the attachment

Avoiding , smoking or any form of activity before measuring, all of which will affect the measurement. Try to relax
in a quiet environment, rest for 10 minutes, and then take measurements. If you have heavy clothing, please detach from the upper arm. Select the arm for blood pressure measurement (usually the left arm) and take blood pressure measurements on the same arm and in the same area. Regularly take blood pressure measurements at the same time every day, because blood pressure will change differently over time.

Common factors that lead to erroneous measurements

Note : Comparative blood pressure measurements should be performed in the same condition (usually referred to quiet conditions)!

If the arm artery is low (high) relative to the heart , it will result in a high (low) blood pressure value. (Each 15cm height difference will produce 1.3kPa/mmHg error value)! This unit is not suitable for newborns.

Note: Please use the original arm cuff that meets the clinical test requirement! The loose or air bag exposed cuff will lead to false blood pressure. The arm will compress the blood vessels due to repeated measurements. This condition will also cause a biased blood pressure value. Therefore, when making repeated measurements, be sure to rest for 3-5 minutes or raise your arm for 3 minutes to reduce the congestion.

Start measuring

Press the [start/stop] key to start automatic measurement

Stop Measurement

If there is any discomfort or for some reason, such as when the airbag is in a persistent over-inflated state, there may be a risk
. At this time, the blood pressure measurement must be stopped. You can press the [START/STOP] button and the Upper Arm Blood Pressure  Monitor will immediately release the air pressure in the cuff to suit your need.

Confirm measurement results Automatic storage of measurement results.

• irregular pulse

The unit can detect the arrhythmia. When this symbol appears after the measurement is completed, it may differ from your normal blood pressure. Please measure it a few more times. If this symbol is displayed frequently, it is recommended that you tell the doctor about this situation, and ask the doctor for frequent information on the irregular heartbeat indicator.

• Error action prompt function:
  The display represents speaking or moving during the measurement, The measurement may not be correct. Please measure again.

• Cuff wearing self-test prompt icon:
  When the cuff is wrapped correctly, the screen displays
  When the cuff is wrapped too loosely, the screen displays
  Please press the [START/STOP] button to turn off the power, rewind the cuff correctly, and measure again

Removing the Arm Strap

Automatic Shutdown

The number is displayed until the power is turned off (if you forget to turn off the power, the monitor will automatically turn off after 30 seconds to save power).
Note : depending on the location, this product is available in mm H g or kPa display mode, and can be used according to the selected display mode according to this operating instructions.

The Upper Arm Blood Pressure Monitor can automatically record 120 measurements. If the measurement result misremembered more than 120 times, the earlier measurement record will be deleted and the new measurement result will be recorded

Check the memory

Delete memory

• This Upper Arm Blood Pressure Monitor can only delete all records at one time. Cannot delete a single record.

• When the measurement result is displayed, press and hold the [MEM] key while pressing the [start/stop] key for about 3 seconds.

• Please do not press the 【start/stop key first, otherwise the power will be cut off.

• . In shutdown mode, press the [SET] button to switch to user 2, which can be switched cyclically.

2Setting taime, date and kPa/mmHg unit selection

The unit automatically records the date and time of each measurement, which is very important .Because the blood pressure of the human body is constantly changing on the same day, it is recommended that you set the correct date and time immediately after installing the battery. Please set the correct date and time as following,(Example: enter time and day -12:08 pm. on December. 08th )

1.  In the shutdown mode, press the [SET] key for 3 seconds, the product enters the function setting mode (if not selected, the system defaults to the manufacturing time).The last two digits of the year will flash on the screen. You can enter the year by pressing the [MEM] button (for example, you can increase the year from 21 to 22 by pressing it one time).
   

2. Press the [SET] button, and there will be a jump of the month in the left corner of the screen. At this time, the first digit of the month starts to flash. You can enter the month by pressing the [MEM] button (for example, you can increase the month from January to 12 months by pressing 11 times).
   

3. Press the [SET] button again, the screen will switch to the date setting, at this time, the last two digits of the date will start to flash. You can enter the date by pressing the [MEM] button (for example, you can change the date from 1st to 08th by pressing the button 7 times).
   

4. Press the [SET] button again, the screen will switch to the time setting. At this time, the first digit (indicating hour) starts to flash. Please input the time by pressing the [MEM] button (for example, you can change the time from 0:00 to 12:00 by pressing the [MEM] button 12 times).
   

5. Press the [SET] button again, and the last two digits (in minutes) will start to flash. You can enter the minute by pressing the [MEM] button (for example, pressing the button 8 times will increase the time from 0 minutes to 8 minutes).
   

6. Press the [SET] button again to enter the kPa/mmHg unit selection. You can select kPa or mmHg by pressing the [MEM] button, “0.0” will display on the screen when kPa is selected, and “0”will display when mmHg is selected.
   

7. In the last step, press the [SET] button, and the date will be displayed after the setting is completed (the date will be displayed first, and it will automatically jump to the time after 3 seconds). When there is no operation, it will automatically shut down after 30 seconds.
   

This unit comes with a SYS warning and a warning bar reminder function. we can read from the height of the World Health Organization blood pressure indicators, blood pressure is distributed in DIA (no WHO voice prompts) and ideal blood pressure, normal blood pressure (green), normal partial hypertension (yellow), mild hypertension, moderate hypertension, and severe hypertension (red). After the measurement is completed, the black zebra crossing appears at the corresponding position according to the SYS and DIA.
The correspondence between color and blood pressure values is shown in the following table:

The meaning of the indicator color:

Green, it represents normal blood pressure .Red ,please consult physician

•  Remove the plug of the air pipe
• Gently bend the air pipe of the arm band and put it into the arm band

Do not over bend the windpipe of the arm band.
Otherwise it may not be possible to make a correct measurement.

Clean
When the product is dirty due to prolonged use, it is necessary to follow the requirements for cleaning.
When the outer shell is dirty, gently wipe it with a wet soft cotton cloth. If the outer shell is seriously soiled, wipe it with a soft dry cloth dipped in 75% medical alcohol. It is recommended to clean at least once a month.

Please pay attention to keeping the cuffs clean. After repeated use for long time, 95% concentration of medical alcohol can be sprayed on the inside of the measuring contact of the cuff for disinfection. If it is heavily soiled, it is recommended to replace the cuff. You can contact the dealer or manufacturer for disposal.

This product is intended for home use and is a personal product. Please use medical alcohol to clean it before use it to others.
Note: This product is not waterproof. Please be careful not to be too moist when cleaning. Also it is not suitable for splashing with water.
Please do not use any other solutions to clean this unit except those method recommended by manufacturer. Because it may damage your Upper Arm Blood Pressure Monitor.

Maintenance

Our company does not authorize any organization and individuals to carry out maintenance. Therefore, please do not disassemble or adjust this unit if you feel the product has functional problems.
Electronic Upper Arm Blood Pressure Monitor is a very precise product, any improper maintenance, disassembly and adjustment will lead to inaccurate measurement.

Avoid the damage of cuff and rubber tube caused by folding Avoid falling or shaking this unit violently.
Within warranty period ,please contact the distributor or manufacturer if you have any questions about the product.

Calibration

The electronic Upper Arm Blood Pressure Monitor has been calibrated at the time of manufacture. We recommend a static pressure test for this Upper Arm Blood Pressure Monitor every 2 years, with the option of an authorized dealer to calibrate your device. At any time, if you question the accuracy of the measurement, please feel free to contact your dealer or manufacturer for disposal.

• Q: Why is the blood pressure value measured at home lower than the blood pressure value measured in the hospital?
  A: I often feel nervous when measuring blood pressure in the hospital, so the measured value will be high. Because I feel calm when measuring in my own home, sometimes it is 20mmHg~30mmHg (2.7kPa~4.0kPa) lower than the hospital’s measurement value. It is very important to know the blood pressure measurement value when you are calm at home. Answer: If the measurement position is higher than the heart, the measurement value will also be low. If the table where the Upper Arm Blood Pressure Monitor is placed is too high, it will cause the armband to be higher than the heart, and the blood pressure value measured at this time will also be low.

• Q: Why is blood pressure measured at home higher than at the hospital?
  A: If you are taking blood pressure medication, it will cause your blood pressure to rise when it loses its potency .After a few hours of taking blood pressure medication, the effect wears off and blood pressure increases accordingly. Consult your doctor for details.
  A: Incorrectly positioned armbands can sometimes lead to high measurements. When the armband is in the wrong position, the blood pressure monitor has a hard time picking up arterial signals, and the blood pressure readings are too high. Please confirm again that the binding position of the armband is correct.
  A: Wrapping the armband too loosely can sometimes lead to high measurements. If the band is wrapped too loosely, the pressure does not reach the arteries, so the blood pressure is measured higher than it actually is .Please be careful not to leave a gap between the cuff and the arm when binding.
  A: Incorrect posture during measurement can sometimes lead to a higher measurement
  result. Measurement postures such as sitting cross-legged, sitting on a couch or at a low desk, or bending forward, can result in high blood pressure readings because of abdominal pressure or because the armband is lower than the heart.

• Q: Why is the blood pressure value measured each time different?
  A: The blood pressure will vary according to the measurement time period. Even within a day, such a change will occur. In order to manage blood pressure correctly, please take measurements at the same time every day.

• Q: Why is there pain and numbness around the arm strap?
  A: This is a temporary phenomenon. Please do not worry .Some pain and numbness may be felt in the arm as blood flow in the artery is temporarily stopped by tightening the arm band to measure blood pressure. When the armband is removed, a short rest can relieve the pain.

• Q: What is the key to blood pressure management?
  A: Please record your medication status and living conditions  .Recording daily changes in blood pressure can provide a clearer picture of blood pressure trends, which can be more helpful in personal health management. In addition, this record is very important for the doctor’s diagnosis. Therefore, we recommend that you record your blood pressure measurements as well as the relevant measurement environment (such as the use of antihypertensive drugs, life status, etc.).

• Q: When is the best time to measure blood pressure?
  Answer: The best time to measure blood pressure is within 1 hour after getting up in the morning, or before going to bed at night. It is also recommended to measure at the same time every day.

High and low pressure

The highest blood pressure when the heart contracts and sends blood to the arteries is called “high pressure”, and the lowest blood pressure when the heart expands to store the next blood is called “low pressure”. They are called systolic blood pressure and diastolic blood pressure.
The following is a standard taxonomy established by the World Health Organization (WHO) for blood pressure, showed in the below table: Unit (mmHg)

At the same time, the United Nations Committee on the Investigation, Evaluation and Treatment of Hypertension in 1988 recommended that whether it is systolic (SYS) or diastolic (DIA), average person must undergo at least three measurements ,further diagnosis is needed when blood pressure is found to be higher than the normal level.

What measure should be taken when blood pressure is too high or low?

• Please consult physician.

• Prolonged ascending blood pressure (different types of SYS) will endanger human health. Deposits on the walls of the blood vessels limit the flow of blood (that can result in arteriosclerosis), which is very dangerous. Because it will cause insufficient blood supply to body’s important part (heart, brain, muscles and etc.), even severely destroy the structure of heart.

• There are many factors that cause high blood pressure. We could divide them into common hypertension and secondary hypertension. Secondary hypertension will lead to organ disorders.
  If your blood pressure value continues to rise, ask physician about possible causes.

• Changing your lifestyle also can prevent or lower hypertension, but this habit must be a part of healthy life, including.

1. Dietary Habit
   Maintain normal weight as guided by doctor. Do not eat too much salt, as many “packaged foods” contain more salt. Avoid eating greasy food. (Packaged foods usually contain large amounts of fat).

2. Preventing Diseases
   Adhere to medical guidelines for preventing certain diseases, such as diabetes, fat metabolic disorders and gout .

3. Living Habit
   Don’t smoke, avoid drinking too much or high concentration drinking; limit the intake of caffeine (coffee, tea, chocolate and etc.)

4. Physical Exercise
   After medical examination, carry out regularly physical exercise; choose the sports program that requires endurance rather than strength. Please note that do not exercise reaching your physical limit. Patients over 40 years old who is with medical history, consult physician before you start to exercise.

Precaution: Consult your physician before using the device for any of the following conditions: common irregular pulse such as atrial or \ ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, old age, pregnancy, pre-eclampsia, renal diseases. Note that PATIENT motion, trembling, shivering may affect the reading.

False Alarm

The LCD will display an error warning If any of the following occurs, as shown in figure marked:

Error code after  leaving the

• Description
• Reason of error
• Solutions

Error code after leaving the| Description| Reason of error| Solutions
---|---|---|---
Er01| Error of measurement| Too much noise to detect an effective pulse signal| Please rest for 2 minutes, adjust the cuff, keep quiet during measurement, do not move or talk.
| Error of measurement| No pulse was detected|
| Error of measurement| Test results deviate from normal range|
| Static pressure exceeds the set protection point| Pressure exceeds design ceiling protection| Measure blood pressure again
| Zero overtime|

1. During the process of returning to zero, the air pressure in the cuff continues to fluctuate;
2. The sensor part of the circuit is abnormal;
3. Sensor damage.

|

1. Keep the cuff intact when returning to zero;
2. Detecting the power supply of the sensor;
3. Replace the sensor.

Er02| Abnormal cuff wearing|

1. The cuff is not worn;
2. Wearing too loose;
3. Wearing too tight;
4. 5s did not reach 10mmHg or 18s did not reach 25mmHg;
5. After the air pressure exceeds 30mmHg, the air pressure is lower than 20mmHg due to the looseness of the cuff;

| Adjust the cuff. It is advisable to insert two fingers just after the tightness is tied. The cuff mouth of the cuff is kept 2cm on the elbow socket.
Lo| Power is not enough| The power is lower than the minimum operating voltage.| Replace the battery

Over Range Alarm
When the test blood pressure value is higher than 280mmhg (excluding 280mmhg), the blood pressure value will continue to flash at a frequency of 2HZ. When the blood pressure value is lower than 280mmhg, the flicker is released.

Other Information

Even a healthy individual, the blood pressure is constantly changing (presenting a jagged line), so when you make comparative measurements, you must be in a fixed state (quiet environment)! If the difference is greater than 2.0 kPa / 15 mmHg if the above conditions are met, or in some cases, in case of irregular hear beat, please consult your doctor.

Troubleshooting

Check whether the product has power
The air pump has begun to inflate, but there is no rise in arm pressure| * Check the hose connection for air leakage or whether it is fully inserted into the socket.
Upper Arm Blood Pressure Monitor s fail to measure blood pressure frequently, or the blood pressure is abnormally high or low.|

1. Re-set the correct cuff.
2. If the left upper arm of the belt is covered with sleeves or other clothing, please take off. Re-measure blood pressure.

self-measured value is different from the measured value of the doctor.| consult your doctor. Record daily measurements and consult your doctor.
After the Upper Arm Blood Pressure Monitor is pressurized, the air pressure of the cuff is released. And the rate is slow even not released at all.| *The air hole connection of the hose in the arm belt has the phenomenon of “plastic ring” falling off. Please put the plastic ring on and measure again.

Any technical problems related to blood pressure monitor, should consult experts or medical personnel, do not disassemble repair without permission !Unauthorized disassembly, will lose the warranty right!

We Famidoc Technology Co., Ltd. solemnly declares that the FDBP-A10BL Upper Arm Blood Pressure Monitor we produced and sold meets the following standards:
Performance safety standard: YY 0670/ IEC 80601-2-30
Electromagnetic compatibility:IEC60601-1-2
Safety standard: GB 9706.1/ IEC60601-1

Claim: The blood pressure value tested by this device is equivalent to that measured by auscultation, and the error is in accordance with the requirements of the code IEC/EN 80601-2-30.
Please read this instruction carefully before use. The product is part of BF application equipment of internal power supply.

If this unit is damaged and need to be discarded ,please dispose of the discarded electronic waste in accordance with the relevant national laws and regulations, dispose of the battery or product should not be directly placed in the garbage can.
Please consult the licensor who responsible for local waste disposal if you have any questions.

Pulse: 40 to 199beats/min
Accuracy| Static pressure: ±0.4 kPa (±3 mmHg)
Pulse: within ±5% of the reading
Power| 3.7V rechargeable lithium battery
Special accessory| Cuff, instruction manual
Size| 153mm101 mm50 mm
Weight| About 300g(including battery)
Withstand pressure for the cuff| 360mmHg
Upper arm circumference| 220~420mm
Software version| V1.0
Electric shock protection type| Class II device
Shock protection procedure| BF application part
Expected use lifetime| Body in 5 years, Cuff in 2 years
Application component| Cuff
Operating condition| Temperature: 5° C~40° C
Humidity: 15% RH~90% RH, No condensation
Atmospheric pressure: 70kPa~106kPa
Transportation and storage condition| Temperature: -25° C~55° C
Humidity: 15% RH~95% RH, No condensation
Atmospheric pressure: 70kPa~106kPa
Please strictly observe the environmental conditions of transportation and storage, otherwise it will affect the accuracy of the equipment.
Component| Quantity
---|---
Upper Arm Blood Pressure Monitor| 1 PCS
Instruction manual| 1 PCS
Cuff| 1 PCS(with trachea)
AAA battery| 4pcs

FCC STATEMENT
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

FCC CAUTION
Changes or modifications 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 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.

This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines. This equipment has very low levels of RF energy that are deemed to comply without testing of specific absorption ratio (SAR).
When using the device, it is recommended to keep the device at a 30cm distance from the human body

Note:

• The Upper Arm Blood Pressure Monitor FDBP-A10BL meets the electromagnetic compatibility requirements of YY0505, YY0670, IEC60601-1-2;

• Users should install and use the electromagnetic compatibility information provided by the random files. Portable and mobile
  RF communication devices may affect the performance of the Upper Arm Blood Pressure Monitor FDBP-A10BL. Avoiding stron electromagnetic interference when used, such as Close to mobile phones, microwave 26 ovens, etc.

• The instructions for the guide and the manufacturer are detailed in the attachment.

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.

• Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this the FDBP-A10BL could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation

• 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 FDBP-A10BL, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Attachment:
Guidance and manufacturer´s declaration – electromagnetic emission – for all EQUIPMENT AND SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic emission

The FDBP-A10BL is intended for use in the electromagnetic environment specified below. The customer or the user of FDBP-A10BL should assure that it is used in such an environment.
Emissions test| Compliance| Electromagnetic environment – guidance
RF emissions CISPR 11| Group 1| The FDBP-A10BL uses RF energy only for its internal function. There for, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B| The FDBP-A10BL 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.
Harmonic emissions IEC 61000-3-2| N/A
Voltage fluctuations/flicker emissions IEC 61000-3-3| N/A

Guidance and manufacturer’s declaration – electromagnetic immunity – for

all EQUIPMENT and SYSTEMS

Guidance and manufacturer´s declaration – electromagnetic immunity

The FDBP-A10BL is intended for use in the electromagnetic environment specified below. The customer or the user of the FDBP-A10BL should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment -guidance
Electrostatic discharge (ESD) IEC 61000-4-2| ± 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 %. If ESD interfere with the operation of equipment, counter measurements such as wrist strap, grounding shall be considered.
---|---|---|---
Electrostatic transient / burst IEC 61000-4-4| ± 2 kV for power supply lines| N/A| Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5| ± 1 kV differential mode ± 2 kV common mode| N/A| Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| 0 % UT (100 % dip in UT) for 0,5 cycle 0 % UT (100 % dip in UT) for 1 cycles 70 % UT (30 % dip in UT) for 25/30cycles 0 % UT (100 % dip in UT) for 250/300

cycles

| N/A| Mains power quality should be that of a typical commercial or hospital environment. If the user of the FDBP-A10BL requires continued operation during power mains interruptions, it is recommended that the FDBP-A10BL be powered from an uninterruptible power supply or a battery.
Power frequency (50/60Hz) 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.
NOTE: UT  is the a. c. mains voltage prior to application of the test level.

Guidance and manufacturer´s declaration – electromagnetic immunity – for

EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING

Guidance and manufacturer’s declaration – electromagnetic immunity

The FDBP-A10BL is intended for use in the electromagnetic environment specified below. The customer or the user of the FDBP-A10BL should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
| | | Portable and mobile RF communications equipment should be used no closer to any part of the FDBP-A10BL, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
Conducted RF IEC 61000-4-6| 3 Vrms
150 kHz to 80 MHz| 3V
150 kHz to 80 MHz| |
---|---|---|---|---
| 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz.a| 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz.a| |
| | 80 MHz to 800 MHz
Radiated RF IEC 61000-4-3| 10 V/m
80 MHz to 2.7 GHz| 10 V/m
80 MHz to 2.7 GHz| ****| 800 MHz to 2.7 GHz
| 385MHz-5785MHz
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communication equipment (Refer to table 9 of IEC 60601-1-2)| 385MHz-5785MHz
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communication equipment (Refer to table 9 of IEC 60601-1-2)| where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
| Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range .c
| | | Interference may occur in the vicinity of equipment marked with the following symbol:
Proximity magnetic fields IEC 61000-4-39| 30 kHz, CW, 8A/m

(This test is applicable only to ME EQUIPMENT and ME SYSTEMS intended for use in the HOME HEALTHCARE ENVIRONMENT)

134, 2 kHz, Pulse modulation 2,1 kHz 65 A/m
13,56 MHz Pulse modulation 50 kHz
7,5 A/m

| N/A| The FDBP-A10BL does not contain magnetically sensitive components.
NOTE 1:   At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2:   These guidelines may not apply in all situations. Electromagnetic is affected by absorption and reflection from structures, objects and people.

• The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
• Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which theFDBP-A10BL is used exceeds the applicable RF compliance level above, the FDBP-A10BL should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re_x005f_x005f_x005f_x005f_x005f_x005f_x005f_x005f_x005f_x005f_x005f orienting or relocating theFDBP-A10BL.
• Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Recommended separation distances between portable and mobile

RF communications equipment and the EQUIPMENT or SYSTEM -for EQUIPMENT and SYSTEMS

Recommended separation distances between portable and mobile RF communications equipment and the FDBP-A10BL

The FDBP-A10BL is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the FDBP- A10BL can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the FDBP-A10BL as recommended below, according to the maximum output power communications equipment

Recommended separation distances between portable and mobile RF communications equipment and the FDBP-A10BL

The FDBP-A10BL is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the FDBP- A10BL can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the FDBP-A10BL as recommended below, according to the maximum output power of the communications equipment
Rated maximum output of transmitter (W)| Separation distance according to frequency of transmitter ( m )
150 kHz to 80 MHz outside ISM and amateur radio bands| 150 kHz to 80 MHz in ISM and amateur radio bands| 80 MHz to 800 MHz| 800 MHz to 2.7 GHz
| | |
0.01| N/A| 0.2| 0.035| 0.07
0.1| N/A| 0.63| 0.11| 0.22
1| N/A| 2| 0.35| 0.7
10| N/A| 6.32| 1.1| 2.21
100| N/A| 20| 35| 70
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.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Famidoc Technology Co., Ltd.
Add.: No. 212 Yilong Road, Hexi Industrial Zone, Jinxia,  Changan Town, Dongguan 523853, Guangdong Province, P.R. China.
Tel.: +86-769-89272488
Website: www.famidoc.com

Name: Shanghai International Holding Corp. GmbH (Europe) Add: Eiffestrasse 80, 20537 Hamburg, Germany
PN:
Description Version : V1.0
Revision date: April 2022 Name: Shanghai International Holding Corp. GmbH (Europe) Add: Eiffestrasse 80, 20537 Hamburg, Germany
PN:
Description Version: V1.0
Revision date: April 2022

References

• 东莞市医脉实业有限公司
• 东莞市医脉实业有限公司

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