SHENZHEN PUMP MEDICAL SYSTEM BF5010B User manual

2017/08/16 Rev. A1
1
ArmAutomatic Blood Pressure Monitor
Instruction Manual
BF5010B
Thanks for purchasing the Arm Automatic Blood Pressure Monitor manufactured by
Bpump.
Please read the instruction manual before usage;
Please dispose the Arm Automatic Blood Pressure Monitor and battery in accordance
with local regulations.

2017/08/16 Rev. A1
2
Table of Contents
1. Safety Information...................................................................................................3
1.1. Warning.............................................................................................................................3
1.2. Contraindications.............................................................................................................4
1.3. Care and maintenance.....................................................................................................4
2. Product Feature .......................................................................................................5
3. Power source.............................................................................................................6
3.1 Battery................................................................................................................................6
3.2 PowerAdapter（Optional）............................................................................................7
4. Clock mode...............................................................................................................8
5. First touch mode ......................................................................................................8
6. Standby mode...........................................................................................................8
7. System Setting..........................................................................................................9
7.1 User conversion...................................................................................................................9
7.2. Setting................................................................................................................................9
8. Take a measurement..............................................................................................10
8.1. Important Noted.............................................................................................................10
8.2. Fitting the cuff................................................................................................................11
8.3. Body posture during measurement...............................................................................11
8.4. Take Measurement.........................................................................................................11
8.5. Mean value......................................................................................................................13
8.6. Memory...........................................................................................................................14
9. Data transmission ..................................................................................................15
10. Power off...............................................................................................................15
11. Error Indication ...................................................................................................15
12. Trouble Shooting..................................................................................................16
13. Specification .........................................................................................................16
15. About Blood Pressure..........................................................................................17
15.1. What is Blood Pressure?..............................................................................................17
15.2. What is high blood pressure?......................................................................................17
15.3. What is morning hypertension (morning surge)?.....................................................18
Reference Standard....................................................................................................18
FCC Statement...........................................................................................................19
Blood Pressure Measurement Chart........................................................................19
Guarantee Card .........................................................................................................19
Explanation of Symbols.............................................................................................20
After-Sale Service.......................................................................................................21

2017/08/16 Rev. A1
3
1. Safety Information
1.1. Warning
1) Self diagnosis and treatment which use measured results may be dangerous. Follow the
instructions of your physician or licensed healthcare provider.
2) If cuff inflation doesn’t stop, remove the cuff or power off the unit, otherwise, it may
result in a hazard condition.
3) Only take measurement with the manufacturer supplied cuff, or else it will lead to
inaccurate results.
4) Do not use the blood pressure monitor when you are close proximity to strong static
electricity or electromagnetic fields, and avoid using the mobile during measurement.
5) Do not use in combination with a hyperbaric oxygen therapy device, or in an
environment where combustible gas may be generated.
6) Do not use in combination with other monitoring device at the same limb, because the
pressurization of the CUFF can temporarily cause loss of function of simultaneously
used monitoring ME EQUIPMENT on the same limb;
7) Do not install or use the unit in the following locations:
Locations subject to vibration such as ambulances and emergency helicopters.
-A location where there is gas or flame.
-A location where there is water or steam.
-A location where chemicals are stored.
-A location where the unit may easily fall.
8) Please follow the environment conditions specified in this manual (Storage and transport
environment: Temperature:-25 ℃～+70 ℃, Humidity:10% ～95%; Operating
environment: Temperature:+5℃～+40℃, Humidity:15%～93%), otherwise, the device
may not be able to achieve the claimed performance.
9) Do not kink the connection tube, or it may cause blood flow interference and result in
harmful injury to the PATIENT due to continuous CUFF pressure;
10) Do not use Luer lock. If Luer lock connectors are used in the construction of tubing,
there is a possibility that they might be inadvertently connected to intravascular fluid
systems, allowing air to be pumped into a blood vessel.
11) This product is suitable for use to self- monitoring of blood pressure in home or used by
the licensed healthcare personnel in hospital.
12) Blood pressure measurements determined with the device are equivalent to those
obtained by a trained observer using the cuff/stethoscope auscultatory method, within
the limit prescribed by the American National Standard, Manual, electronic or
automated sphygmomanometers.
13) Keep out of reach of infants, small children, and compromised people who cannot
express their consent. Playing the air tube may result in suffocate children, and Children
may swallow small parts and lead to suffocation.
14) Children must be supervised to ensure that they are not play with the device.
15) Use only manufacturer authorized parts and accessories. Parts and accessories not
approved for use with the device may damage the unit.

2017/08/16 Rev. A1
4
16) Adapter is considered as a part of me equipment during powered by adapter
17) Be careful not to rest your arm on the air tube. This will restrict the flow of air to the
cuff.
18) Do not measurement too frequent, or else it may result in bruising where the cuff is
applied.
19) Do not apply the cuff over a wound or inflamed area.
20) Do not apply the cuff on the same limb where intravascular access or therapy or an
arterio-venous (A-V) shunt is present, because of temporary interference to blood flow
and could result in injury to the patient.
21) Do not apply the cuff on the arm on the side where a mastectomy has done, because of
temporary interference to blood flow and could result in injury to the patient.
22) The application of the cuff and its pressurization on the arm can cause temporary
interference to blood flow, but it would not result in injury to the patient.
23) Operation of the device does not result in prolonged impairment of the circulation of the
blood of the patient.
24) Direct plug is considered as disconnect device, please do not place the equipment in a
difficultly operation position.
25) When using the device, the patient is an intended operator.
26) Do not serviced or maintained while in use with the patient.
1.2. Contraindications
1) Do not use the blood pressure monitor for any other purpose except measuring the blood
pressure of human body.
2) Those who have arrhythmia, diabetes, blood circulation or apoplexy problem, please use
under the physician’s instruction.
3) Clinical testing has not been conducted on newborn infants and pregnant women. Do not
use in infants and pregnant women.
4) The common arrhythmia such as atria premature beats, premature ventricular and atrial
fibrillation will lead to inaccurate results or error.
1.3. Care and maintenance
1) The battery can’t be replaced, do not attempt to disassemble, repair or modify the unit or
cuff.
2) Avoid high temperature, moisture, dust and direct sunlight.
3) Clean the body with soft clean wet cloth, do not wipe with alcohol or other corrosive
liquids.
4) Do not wet or clean the cuff with water.
5) Clean the cuff with soft dry cloth after measurement.
6) Do not use at extremely high temperature, high humidity, or high altitude.
7) Do not drop or expose the device to heavy shock.
8) Do not use the unit near large equipment that uses a switching relay for power ON/OFF.
9) Turn off the power switch if the unit will not use for a long time.
10) The blood pressure monitor has gone through several trials of testing to ensure the
measurement accuracy. It is recommended that the performance be checked every 2 years

2017/08/16 Rev. A1
5
and after maintenance and repair.
11) Do not disassemble or modify the structure of the unit and damage the safety
performance. If you need service, please contact the manufacturer, the maintenance
should be done by authorized persons of manufacturer. Maintenance of the necessary
technical document, including the schematics, key components list and etc., will
provided by the manufacturer for maintenance personnel.
12) Care and maintenance of lithium battery:
Please keep the unit away from the fire or heat source, do not put the waste of the
unit or battery into fire.
Do not frequently run out of battery , avoid affecting the battery life.
Do not forcibly boot after battery runs out ,avoid irreversible damage to the battery.
Use the correct adapter designed for your local voltage (AC 100-240 V)
If the unit is to remain unused for an extended period(more than 7 days), please
ensure that the battery retains a certain amount of electricity , turn off the power
switch to disconnect the lithium battery.
Precaution！Please read the enclosed instruction.
2. Product Feature
Intended Use
It is intended for measuring systolic, diastolic blood pressure and pulse rate of an
adult over the counter.
Body
Fig 1
Cuff(Type BF Applied Part)
Model:BC1000
ApplicableArm Circumference:
BC1000: 22cm to 36cm (8.7in to 14.2in)

2017/08/16 Rev. A1
6
Cuff Label
Fig 2
Note:
Symbol for‖TYPE BFAPPLIED PART‖
Display
Fig 3
3. Power source
3.1 Battery
3.1.1 Installation and replacement
1）Remove battery cover
2）Load 3 standard AA alkaline battery as indicated in figure below
Model: BC××××

2017/08/16 Rev. A1
7
Fig 4
3）Install back the battery cover
4）Replace the battery if low battery icon is displayed
If the battery symbol turn red and flicker, please replace with new batteries or
connect the USB cable to use, otherwise the unit will not function properly.
Use 3 same brand 1.5 V AA alkaline batteries.
Do not mix the new and old batteries.
Remove the battery if the unit is to remain unused for an extended period.
Reset the time and date after battery replacement.
3.1.2 Battery Life
Three new LR6 (AA) batteries will last for approximately 200 measurements, if
measurements are taken once a day at room temperature (23°C).
The batteries enclosed in the package are used for demonstration purpose. It is possible
these batteries will therefore not last for 200 measurements.
3.2 PowerAdapter（Optional）
1) Connect the AC adapter to the AC adapter connector of the main unit
2) Plug the socket into electric outlet.
Use the correct adapter designed for your local voltage (Recommend: Power adapter
specification, AC100-240V, 50/60Hz, 400mA; Output: 5.0V 1.0A.) Which
comply IEC 60601-1 standard.
When operating the unit please do not tangle the power cords.
Use the manufacturer USB cable only.
Do not touch the AC adapter with wet hand.

2017/08/16 Rev. A1
8
4. Clock mode
With monitor power off, touch the 【 】 button into the clock mode, display the current
time (hour/minute).(Fig5)
Under any mode, press and hold the 【 】button for 3 seconds will enter the clock mode.
Under the clock mode, press and hold the【 】button for 3 seconds or unattended 3 minutes
will shut off the device.
5. First touch mode
Under the clock mode, press the 【 】button to lit up the touch button area,(Fig6) press the
button into next step.
6. Standby mode
Under the first touch mode, without operation 2s to enter the standby mode, which can
automatically detect the current settings and display the Bluetooth symbol, Horn symbol, blood
pressure unit and user group.（Fig7）
Press the【 】button or without operation 20s during setting, reading the memory and mean
value will return to the standby mode.
Fig5
Fig6
Fig7

2017/08/16 Rev. A1
9
7. System Setting
7.1 User conversion
The blood pressure monitor is capable to hold 2 sets of memory data. Select the correct user
group before measurement.
User conversion:
Under the first touch mode and standby mode, press the【Set】button will
automatically change the user conversion either from user 1 or user 2.
7.2. Setting
1) Press the【Set】button for 1s to enter the setting mode, and Year digits display.
a) Change number.
Press the 【►】button to increase one number.
Press the【◄】button to decrease one number.
Hold down the 【◄】or 【►】button, the number will change rapidly.
b) Enter the digit of year number.(Fig8)
c) Press the 【Set】button will proceed to month setting.
d) Repeat step a) to c) to set month, day, hour and minutes.(Fig9 to Fig12)
2) Unit with broadcast.
a) Continues the broadcast setting, press the 【◄】or【►】button will
automatically turn on or off the broadcast system as shown on Fig 13 or Fig 14.
b) Press the 【Set】button to confirm.
3) Unit coversion (mmHg to kPa ).
a) Press the【◄】or【►】button will automatically change the unit conversion either
from mmHg or kPa as shown on Fig 15 or Fig 16.
b) Press the 【Set】button to confirm and return to standby mode.

2017/08/16 Rev. A1
10
Time is set to 24 hours.
Press the 【 】button or unattended 20s during setting will stop setting and return standby
mode.
When press the 【 】button to exit during setting, the items had been confirmed will be
saved, the no confirmed items retain original status.
Under the setting mode, press the 【 】button for 3s will enter the clock mode, press the
【 】button for 6s ,the device will be shut off .
8. Take a measurement
8.1. Important Noted
Don't eat, drink alcohol, smoke, take a shower or exercise for at least 30 minutes before you
take your blood pressure and don't use any medicines that can raise blood pressure.
Try not to take your blood pressure if you are nervous or upset. If we are nervous, anxious,
or agitated our blood pressure will rise.
Rest for 5～10 minutes before taking a reading. Sit in a comfortable, relaxed position. Don't
move around or talk while taking the blood pressure. Leave your legs in one position, breath
freely and calmly.
The blood pressure cuff should fit over about 3/4 of your upper arm. It should easily go
around the arm and the Velcro should close tightly.
If you can, use the same arm for every reading.
Measuring blood pressure at the same time on different days should give about the same
reading (excluding outside influences like exercise).
Changes in medication or nutritional supplement can alter your result. Please consult your
doctor before taking or stopping medications or supplement.
Fig8
Fig9
Fig10
Fig11
Fig12
Fig13
Fig14
Fig15
Fig16

2017/08/16 Rev. A1
11
8.2. Fitting the cuff
1) Plug in the air tube connector into the main unit
2) Wrap the cuff around the upper left arm or upper right arm.
3) Tighten the cuff around the arm, make sure the cuff is approximately 2cm～3cm (1in～2in)
above the elbow.(Fig 17)
Fig 17
4) Make sure cuff air tube outlet is facing your finger. Do not over tighten. Approximate
one finger should be able to fit underneath the cuff after tightening.
5) Relax, place the elbow on the desk with palm facing up; the cuff should be level with
your heart. If the cuff doesn’t fit your arm, the reading accuracy may be affected.
Do not bend with the cuff or the air tube.
To detach the cuff, unplug the air tube connector from the main unit
Do not inflate prior fitting the cuff.
Change the cuff, if it there is a leakage or if the cuff is not working properly.
Only use the manufacturer cuff to ensure the measurement accuracy.
8.3. Body posture during measurement
Relax, place the elbow on the desk with palm facing up; cuff should be at the heart level (Fig
18).The reading accuracy may be affected if the cuff is not fitted properly. The arm should be
at the same level of your heart. If your arm is too low, your reading will be too high. If your
arm is too high, your reading will be too low.
Fig 18
8.4. Take Measurement
After setting and wearing the cuff, the unit is ready for measurement:

2017/08/16 Rev. A1
12
1) For accurate result please relax, do not smoke, take deep breath, speak loudly or move
around during the measurement.
2) Press the 【 】 button under the first touch mode or standby mode to start the
measurement.
3) The display will turn to Fig 19, and the cuff begins inflating.
4) When the device detects a pulse, the heart symbol will flash as shown on Fig 20. The
cuff inflates, and your pulse and blood pressure measurement is taken.
5) If the cuff is too loose, the cuff self-test symbol will flash for 30 seconds, at this case,
please confirm the cuff is wrapped up correctly, and take the measurement again.
6) When completing the test, the cuff will automatically deflate and the test result will be
display on the screen . The device will broadcast the result. The WHO blood pressure
level (Optm, Norm, Pre.H, H1,H2,H3) will be displayed on the screen as show on Fig21
and Fig22. The blood pressure level classification and definition as show in Table 1.
7) You may turn off the unit or compare with the previous results.
8) If a problem occurs during the test, ―Err‖ will display on the screen.
9) In the end of measurement, ― ‖ will display on the screen when irregular pulse is
detected.
10) Complete the measurement, press the 【 】button to take a measurement again; Press
down the 【 】button for 3s to return the standby mode.
11) Press down the【 】button exceed 6s to shut off the unit, or automatic shut off without
operation for 3min.
Please refer to Table 1 for the blood pressure level classification and definition.
Table 1
Fig19
Fig20
Fig21
Fig22

2017/08/16 Rev. A1
13
WHO Blood pressure level
Blood pressure range
Severe hypertension (H3)
Systolic≥180mmHg or/and Diastolic≥110mmHg
Moderate hypertension (H2)
Systolic≥160mmHg or/and Diastolic≥100mmHg
Mild hypertension (H1)
Systolic≥140mmHg or/and Diastolic≥90mmHg
Prehypertension（Pre.H）
Systolic≥130mmHg or/and Diastolic≥85mmHg
Normal (Norm)
Systolic≥120mmHg or/and Diastolic≥80mmHg
Optimal (Optm)
Systolic <120mmHg and Diastolic <80mmHg
Notes:
Do not self-diagnosis according to measurement results. Follow the instructions of your
physician or licensed healthcare provider.
If the device caused any discomfort during measurement or fail to perform as indicated, press
the 【 】button to discontinue measurement.
The time of the pressure reduced from 260mmHg (34.67kPa) to 15mmHg (2kPa) does not
exceed 10s.
If cuff inflated up to 300 mmHg (40 kPa) doesn’t stop, please remove the cuff or power off
the unit.
8.5. Mean value
1) Press the 【 】button to read the mean value.
2) The screen will display the average data of the most recent 3 sets as show on Fig23 and
broadcast the data.
3) Press the 【User】button to change user group.
When reading the mean value, press the 【 】button,the average data will flick
and the device broadcasts the data again.
Without any operation for 20s, the unit will automatically turn to standby mode.
Under mean value mode, press down the 【 】button for 3s to return the clock
mode, press and hold the 【 】button exceed 6s to shut off the unit.
Fig23

2017/08/16 Rev. A1
14
8.6. Memory
The Memory 1 and Memory 2 can hold up to 60 readings each.
1) Enter the memory reading mode.
Press the 【 】 button to enter the memory reading mode.
2) Read the memory values.
Under the Memory reading mode, press 【►】button to view the latest value to the
earliest value. Press the【◄】button to view the earliest value to the latest value.
(a) Enter the memory reading mode, the month, day and data number of the memory
data being viewed will display for 1s,(Fig24) and then turns to (b).
(b) Hour, minute and data number of the memory data being viewed will display for
1s,(Fig25) and then turns to (c).
(c) Display the systolic, diastolic, pulse rate and the blood pressure level as show on
Fig26. Press the 【 】 button to return (a).
When reading the memory values, if the result shows the heart mark, it is suggested that
the irregular pulse is detected.
.Refer 7.1 to change user group.
Without any operation for 20s, the unit will automatically turn to standby mode.
Under memory reading mode, press down the 【 】button for 3s to return the
clock mode, press and hold the 【 】button exceed 6s to shut off the unit.
3) Delete the memory values
a) Enter the memory reading mode.
b) Press and hold the 【 】 button until the ―—― displays.
c) The unit will only delete the present memory data set, the other memory data set
will not be affected.
d) The device is not capable to delete a single data.
Fig24
Fig25
Fig26

2017/08/16 Rev. A1
15
9. Data transmission
The Bluetooth function of Blood pressure monitor turns on automatically simultaneously
with device’s powering on.
10. Power off
（1）Under the clock mode, press the 【 】button for 3s.
（2）Press and hold the 【 】button for 6s except the clock mode.
（3）While completing the measurement or under the standby mode, without operation for
3min, the device will automatically shut off.
11. Error Indication
List of Error code.
Error
Cause
How to correct
cuff self-test
symbol
Power on, cuff inflation rate is
too low or main unit does not
connect with the cuff.
(1) Reconnect the air tube connector with
the main unit .
(2) Cuff or bladder leakage, if necessary
purchased a new one.
(3) Confirm the cuff is wrapped up
correctly (ref 8), retake the measurement .
Er 02
Weak Signal or cuff is too
loose;
Heavy shock during the
measurement;
Bad Signal，moving or
talking during the
measurement;
Abnormal measurement
results.
Cuff too loose，Confirm the cuff is
wrapped up correctly(ref 8)retake the
measurement.
Remain still, retake the measurement
(ref 8)
Remain still, retake the measurement.
Cuff should be at the heart level, quiet
and relaxed when measuring.
Lo
Low battery power, cannot
inflate
Replace the battery(ref 3).

2017/08/16 Rev. A1
16
12. Trouble Shooting
When the unit encounters malfunction during the use, refer to table below:
Abnormal
How to correct
Press the 【 】button, the LED
without any display.
(1) Check the power switch is turn on.
(2) Connect the USB cable or replace the batteries, then
try again.
Measured value are abnormally
high or low
(1) Confirm the cuff is wrapped up correctly.
(2) If the user clothing restricts the normal flow, please
remove the obstructing clothing and retake the
measurement
(3) Relax, place the elbow on the desk with palm facing up;
cuff should align with heart level. Retake the
measurement
Cuff inflation rate is too low or
does not inflate
（1）Reconnect the air tube connector with the main unit
（2）Cuff or bladder leakage, if necessary purchased a
new one.
Cuff deflates too quickly.
（1）Cuff too loose，confirm the cuff is wrapped up
correctly.
Measure value is different from the
hospital or the value is inconsistent
（1）Blood pressure value is varied during the day which
also will affect by the human emotional and physical
condition
（2）Record the variance and consult to the doctor
*If the above suggestion doesn’t remediable, please consult the manufacturer.
13. Specification
Description
Arm automatic blood pressure
monitor
Model
BF5010B
Display
LED Digital Display
Measuring
principle
Oscillometric Method
Measurement
Range
Pressure: 0mmHg~280mmHg
(0kPa~37.3kPa)
Pulse: 40 pulse/min ~180 pulse/min
Accuracy
Pressure : ±3mmHg (±0.4kPa)
Pulse: ±5%
Memory
2 Memory sets, 60 reading each set.
Automatic
power off
Unattended 3 minutes
Power source
Rated input: Battery: 5.0V
1.0A (Micro USB)
Internal battery: 4.5Vd.c. (3×AA)
Data
transmission
Bluetooth
Protection
against
electric shock
Type BF
IP
classification
IP21
Mode of
operation
Continuous
Applied part
Cuff
Operating
Environment
Temperature:+5℃～+40℃；
Humidity:15%～93%
Pressure: 70.0kPa～106.0kPa
Storage and
transport
Temperature:-25℃～+70℃；
Humidity:10%～95%

2017/08/16 Rev. A1
17
Altitude: ≤3000 m
Environment
Pressure:50.0kPa～106.0kPa
Weight
380g (Not include batteies)
Size
120 mm×120mm×40mm
Life time
(Body)
Body
10000 times
Contents
·Cuff
·USB cable
·Storage case (Optional)
·Instruction Manual
Cuff
10000 times
This unit is intended for home use and the specification may be changed without prior notice.
Disposal
This product must not be disposed together with the domestic waste.
All users are obliged to hand in all electrical or electronic devices, regardless of whether or not
they contain toxic substances, at a municipal or commercial collection point so that they can be
disposed of in an environmentally acceptable manner.
Please remove the battery before disposing of the equipment. Do not dispose of old batteries with
your household waste, but dispose of them at a battery collection station at a recycling site or in a
shop.
Consult your municipal authority or your dealer for information about disposal.
15. About Blood Pressure
15.1. What is Blood Pressure?
Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels,
and is one of the principal vital signs.
Two pressures are measured for a blood pressure reading:
Systolic blood pressure is a measure of blood pressure while the heart is beating.
Diastolic pressure is a measure of blood pressure while the heart is relaxed.
15.2. What is high blood pressure?
High blood pressure, also known as HBP or hypertension, is a widely misunderstood medical
condition. Some people think that those with hypertension are tense, nervous or hyperactive, but
hypertension has nothing to do with personality traits. The truth is, you can be a calm, relaxed
person and still have HBP. Let's look at the facts about blood pressure so you can better
understand how your body works and why it is smart to start protecting yourself now, no matter
what your blood pressure numbers are.
By keeping your blood pressure in the healthy range, you are:
Reducing your risk of your vascular walls becoming overstretched and injured
Reducing your risk of your heart having to pump harder to compensate for blockages
Protecting your entire body so that your tissue receives regular supplies of blood that is rich in
the oxygen it needs.
According to World Health organization standard, the blood pressure level classification and
definition as following:

2017/08/16 Rev. A1
18
Category
Systolic(mmHg)
Diastolic(mmHg)
Desirable
120 and
80
Normal
120-129 and/or
80-84
Pre hypertension
130-139 and/or
85-89
Hypertension:
≥140 and/or
≥90
Stage 1 Hypertension
140-159 and/or
90-99
Stage 2 Hypertension
160-179 and/or
100-109
Hypertensive Crisis
≥180 and/or
≥110
These categories were defined by the American Heart Association. This chart applies to adults
age 20 and older.
15.3. What is morning hypertension (morning surge)?
Morning high blood pressure or morning surge is defined as the weekly average for morning
blood pressure reading measured within 1 hour to 2 hours after awakening in the morning and
exceeding 135/85mm Hg. Studies have shown that exaggerated morning blood pressure surge is a
risk for cardiovascular events which includes ischemic and hemorrhagic stroke. Cardiovascular
events have been shown to be exaggerated in the morning to coincide with morning high blood
pressure. In fact heart attack, stroke and heart failure have been shown to fall particularly on a
Monday amongst all the other days of the week.
Organ damage and diabetic complications have also been shown to be linked with morning blood
pressure surges just in the same way as small artery disease and multiple cerebral infarcts in elder
members of society. Morning high blood pressure has shown some correlation with initial stage
and progression of atherosclerosis. Patients with well controlled blood pressure may still have
high morning blood pressure and this happens in 50% of the cases. Patients with morning
hypertension have a 78% more chance of stroke compared with 48% of other hypertensive
patients without morning high blood pressure. Morning hypertension has also been associated
with changes in heart size and rhythm. This may lead to heart attack or heart failure.
Morning Hypertension can only detect within 1 hour to 2 hours after awakening, recommended
user monitor their own blood pressure at home.
Reference Standard
·IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part1: General requirements for
safety and essential performance.
·IEC 60601-1-2:2014 Medical electrical equipment - Part1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic compatibility –
Requirements and tests
·IEC 80601-2-30:2009+A1:2013 Medical electrical equipment - Part 2-30: Particular
requirements for the basic safety and essential performance of automated non-invasive
sphygmomanometers.
·ANSI/AAMI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2:Clinical validation

2017/08/16 Rev. A1
19
of automated measurement type
FCC Statement
Warning: Changes or modifications to this unit not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
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.
FCC ID: 2AAS7-BFA02
The device has been evaluated to meet general RF exposure requirement. The device can be
used in portable exposure condition without restriction.
Blood Pressure Measurement Chart
Date
Time
SYS/DIA
Pulse
Remark
Date
Time
SYS/DIA
Pulse
Remark
Guarantee Card
Product Model
Product SN
Date of Purchase
Distributor
Customer Name
Tel
Address
Details of the faults:
Warranty Rule
·The unit of this product is guaranteed by PUMP for a period of 1year after the date of
purchase.

2017/08/16 Rev. A1
20
·The guarantee does not cover any of the following:
-- Risks of transport.
-- Damages caused by the operating environment which is not in accordance with the
product requirements.
-- Defects resulting from repair by unauthorized persons.
-- Damages caused by user whom disassemble or modify the structure of the unit and
damage the safety performance.
-- Product guarantee card is not accord with the serial number or the guarantee card is
changed
·This product is medical device, to ensure the accuracy of the product when using it, we
would like to continue to provide you with paid services after the guarantee periods.
Explanation of Symbols
Symbol for ―batch code‖
Symbol for ―Date of manufacture‖
Symbol for ―manufacturer‖
0123 Symbol for ―CE‖
Symbol for ―Follow operating instructions‖
Symbol for ―TYPE BFAPPLIED PART‖
Symbol for ―electrical and electronic equipment‖
IP21 Symbol for ―IP classification‖
Symbol for ―AUTHORISED REPRESENTATIVE IN THE EUROPEAN
COMMUNITY‖
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
Certificate
Product Name: ArmAutomatic Blood Pressure Monitor
Product Model: BF5010B
Inspector: