PUMP MEDICAL SYSTEM BFY Blood Pressure Monitor User Manual

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Rev. A1
Blood Pressure Monitor
Instruction Manual
BF2214(0B)
1.
Table of Contents
Safety Information ................................................................................................ 2
1.1 Warning.............................................................................................................................. 2
1.2 Precaution .......................................................................................................................... 2
2.
3.
Product Feature .................................................................................................... 3
Pre Measurement .................................................................................................. 4
3.1 Battery ................................................................................................................................ 4
3.2 Setting Date and Time ...................................................................................................... 5
4.
Take a Measurement ............................................................................................ 5
4.1 Important Notes ................................................................................................................ 5
4.2 Applying the Wrist Cuff ................................................................................................... 6
4.3 Body Posture during Measurement ................................................................................. 6
4.4 Taking a Measurement ..................................................................................................... 6
4.5 Data Transmission ............................................................................................................. 7
4.6 Memory .............................................................................................................................. 8
5. Error Indication .................................................................................................... 8
6. Trouble Shooting ................................................................................................... 8
7. Specification .......................................................................................................... 9
8．About Blood Pressure .......................................................................................... 13
8.1 What is Blood Pressure? ................................................................................................. 13
8.2 What is High Blood Pressure? ....................................................................................... 13
8.3 What is Morning Hypertension (Morning Surge)? ...................................................... 14
Reference Standard.................................................................................................... 14
Blood Pressure Measurement Chart ........................................................................ 15
Guarantee Card ......................................................................................................... 15
After-Sale Service....................................................................................................... 16
Rev. A1
1.
Safety Information
1.1 Warning
•
Self diagnosis and treatment which use measured results may be dangerous. Follow the
instructions of your physician or licensed healthcare provider.
•
Those who have arrhythmia, diabetes, blood circulation or apoplexy problem, please use
under the physician’s instruction.
•
If cuff inflation doesn’t stop, remove the cuff or power off the unit, otherwise, it may result in
a hazard condition.
•
This equipment is not suitable for the neonate, infant and who can't communicate or interact
independently.
•
Do not use the blood pressure monitor for any other purpose except measuring the blood
pressure of human body.
•
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.
•
Do not use in combination with a hyperbaric oxygen therapy device, or in an environment
where combustible gas may be generated.
•
Do not install 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.
•
The common arrhythmia such as atrial premature beats, premature ventricular and atrial
fibrillation will lead to inaccurate results or error.
•
Measurements or stores need to take into account environment variables, or else it would lead
to inaccurate measurement.
•
When using or replacing the batteries, the operator should not touch those parts and the
patient simultaneously.
•
The battery has positive/negative polarity. If the battery does not connect well to the unit, do
not forcibly connect it.
•
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.
1.2 Precaution
•
•
•
•
•
•
Do not attempt to disassemble, repair or modify the blood pressure monitor.
Avoid high temperature, moisture, dust and direct sunlight.
Clean the body with soft dry cloth dipped in a concentration of 75% medical alcohol.
Do not wet or clean the cuff with water.
Clean the cuff with soft dry cloth after measurement.
Do not use at extremely high temperature, high humidity, or high altitude. Use only within the
required ambient conditions.
•
Do not drop or expose the device to heavy shock.
Rev. A1
•
•
•
Do not use the unit near large equipment that uses a switching relay for power ON/OFF.
Remove the batteries if the unit will not use for a long time.
Clinical testing has not been conducted on newborn infants and pregnant women. Do not use
on newborn infants and pregnant women.
•
The blood pressure monitor has gone through several trials of testing to ensure the
measurement accuracy. The end user should conduct a manufacturer recommended inspection
and calibration annually.
•
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.
•
Keep out of reach of infants, small children, and compromised people who cannot express
their consent.
Precaution！Please read the enclosed instruction.
2. Product Feature
Scope: Measurement of Human Blood Pressure and Pulse Rate for Adults.
Body
Fig 1
Cuff Label (Type BF Applied Part)
Applicable Wrist Circumference: 135 mm to 215 mm
Fig 2
Rev. A1
Note:
Symbol for”TYPE BF APPLIED PART”
Display
Fig 3
3.
Pre Measurement
3.1 Battery
3.1.1 Installation and Replacement
1) Remove battery cover.
2) Load 2 standard AAA alkaline batteries.
3) Install back the battery cover.
4) Replace the battery if low battery icon is displayed.
•
If the low battery symbol
is display, replace with new batteries, otherwise the
unit will not function properly.
•
Use 2 same brand 1.5 V AAA alkaline batteries and aware of the polarity of batteries
during installation.
•
•
•
Do not mix the new and old batteries.
Remove the batteries if the unit is to remain unused for an extended period.
Reset the time and date after battery replacement.
3.1.2 Battery Life
•
Two new LR03 (AAA) 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
that these batteries will therefore not last for 200 measurements.
Rev. A1
•
The battery life can be confirmed in the bottom right of the display. If the low battery
symbol
is display, remaining power is low, replace with new batteries.
3.2 Setting Date and Time
1)
2)
3)
With monitor power off.
Hold the【M】and【ON/OFF】button for 3 seconds, Year digits blinking.
a) Change number.
i. Press the【M】memory button to advance one number.
ii. Hold down the【M】memory button, the number will change rapidly.
b) Enter the two digit of the year number.
c) Press the【ON/OFF】button will proceed to month setting.
d) Repeat step a) to c) to set month, day, hour and minutes.
Unit Conversion (mmHg to kPa).
a) Press the 【M】 memory button will automatically change the unit conversion as
shown on Fig 4 or Fig 5.
b) Complete setting the unit, press【ON/OFF】button to exit.
Fig 4
4.
Fig 5
Take a Measurement
4.1 Important Notes
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.
Do not try to take your blood pressure if you are nervous or upset. If you are nervous,
anxious, or agitated your 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 wrist. It should easily go around
the wrist and the Velcro should close tightly.
If you can, use the same wrist 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.
Rev. A1
4.2 Applying the Wrist Cuff
1)
2)
3)
4)
5)
6)
Roll up sleeve.
Make sure your sleeve is not rolled up too tightly on your arm. This may constrict the
flow of blood in your arm.
Wrap the cuff directly against your skin.
Do not apply the cuff over the clothes. Place the cuff over your left wrist with your left
thumb facing upward.
Position the cuff leaving a clearance of approximately 10 mm to 15 mm between the
cuff and the bottom of your palm (Fig 6).
Hold the bottom part of the cuff and wrap it around the wrist so it fits comfortably and
securely around your wrist (Fig 7).
Fold the remaining part of the wrist cuff back out of the way.
If you cannot apply the cuff on the left wrist, you also can take a measurement using the
right wrist position.
Fig 6
Fig 7
4.3 Body Posture during Measurement
Hold your wrist at the same level with your heart as show on Fig 8. If your arm is too
low, your reading will be too high. If your arm is too high, your
reading will be too low.
Keep your elbow firmly to avoid body movement. Sit still and do
not talk or move during the measurement.
The fingers do not force when measurement. The measurement
wrist do not bent up or down, and do not clenched fist.
Do not use the other hand to support the wrist strap, otherwise it
will affect the measurement result.
Fig 8
4.4 Taking a Measurement
After installing the batteries and fitting the cuff, the unit is ready for measurement:
1)
In order to get the most accurate result, please relax, do not smoke or take deep breath,
and do not speak loudly or move around during the measurement.
Rev. A1
2)
3)
Turn on the 【ON/OFF】 button. Display will lit-up for 1 second as shown on Fig 9.
Then the display switch to Fig 10, a beep sound indicates the monitor has begun taking
the measurement.
4) When the device detects a pulse, the heart symbol will flash as shown on Fig 11. 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
display on the screen as shown on Fig 12.
7) When completing the test, if the device detects an arrhythmia, the heart symbol will
flash.
8) You may turn off the unit or compare with the previous results.
9) Automatic shut off in 3 minutes.
10) If a problem occurs during the test, “Err” will display on the screen.
Fig 9
Fig 10
Fig 11
Fig 12
Notes:
•
Do not self-diagnosis according to measurement results. Follow the instructions of your
physician or licensed healthcare provider.
•
•
Only use the cuff provided by manufacturer to ensure the measurement accuracy.
The blood pressure monitor only will remind the end user on high blood pressure as follows:
When the systolic pressure is greater or equal to 140mmHg and/or when the diastolic pressure
is greater or equal to 90mmHg as abnormal. The display will flash to remind the end user of
the blood pressure abnormality.
If the device cause any discomfort during measurement or fail to perform as indicated, turn
off the power or discontinue use.
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.
•
•
•
4.5 Data Transmission
The device can transmit the data to the data management system by Bluetooth. When complete
the measurement, the Bluetooth symbol of display will flash (Fig 12). After data transmission,
the Bluetooth symbol will disappear.
Note: when the Bluetooth symbol disappeared, you can turn off the power after, otherwise, may
clause the failure of data transmission.
Rev. A1
4.6 Memory
The internal memory can hold up to 90 readings.
1) Memory Review
a)
b)
c)
2)
To access readings from the memory, press the【M】memory button.
Wait for 2 seconds, the average of most recent 3 sets of data will display.
When holding the【M】memory button the user can view the data from the most recent
date to the oldest date.
Delete Memory Data
a) Enter into the memory mode.
b) Press and hold the【M】and【ON/OFF】button until the “---” displayed.
c) All the data will be deleted. The device is not capable to delete a single data.
d) Press the【ON/OFF】button for 3 seconds to exit the memory mode and turn off.
5.
Error Indication
List of error codes are as follows:
Error
Cuff
self-test
symbol
6.
Cause
How to correct
(1)
Power on, cuff inflation rate is too
low or main unit does not connect
with the cuff or cuff is too loose.
Cuff or bladder leakage, please connect
manufacturer.
(2)
Confirm the cuff is wrapped up
correctly (ref 4.2), retake the
measurement.
Cuff too loose. Confirm the cuff is wrapped up
correctly (ref 4.2) retake the measurement.
The fingers do not force when measurement.
The measurement wrist do not bent up or
down, do not clenched fist. Then retake the
measurement (ref 4.3).
Er 2
Weak signal or cuff is too loose.
Er 3
Heavy
shock
measurement.
Er 5
Bad signal, moving or talking
during the measurement.
Remain still, and retake the measurement (ref
4.1).
Er7
Measurement abnormal.
Please retake the measurement.
Lo
Low battery power, cannot inflate.
Change the batteries (ref 3.1).
during
the
Trouble Shooting
When the unit encounters malfunction during the use, refer to table below:
Abnormal
How to correct
After batteries installation, power
on, no display.
(1) Check batteries polarity.
(2) If still cannot power on, reinstall the batteries or
change new batteries.
(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
Measured value is abnormally high
or low.
Rev. A1
measurement.
(3) Place the cuff over your left wrist with your left thumb
facing upward and hold your wrist at the same level
with your heart. Retake the measurement.
(1)
Cuff or bladder leakage, please connect
Cuff inflation rate is too low or
manufacturer.
does not inflate.
(2)
Confirm the cuff is wrapped up correctly (ref 4.2),
retake the measurement.
(1) Cuff too loose; confirm the cuff is wrapped up
Cuff deflates too quickly.
correctly.
Measure value is different from the （1） Blood pressure value is varied during the day
which also will affect by the human emotional and
hospital
or
the
value
is
physical condition.
inconsistent.
（2） Record the variance and consult to the doctor.
*If the above suggestion doesn’t remediable, please dial Service Hotline: 86-4006 755 009 for
consultant.
7.
Specification
Description
Blood Pressure Monitor
Model
BF2214(0B)
Display
LCD Digital Display
Measuring
Principle
Oscillometric Method
Measurement
Range
Pressure: 0mmHg~280mmHg
(0kPa~37.3kPa)
Pulse: 40 pulse/min ~180
pulse/min
Accuracy
Memory
90
sets
memory
measurement values
Automatic
Power Off
Unattended 3 minutes
Power Source
2 AAA Alkaline batteries
Battery Life
Approx 200 measurements
Life Time
Five years or 10000 times
IP classification
IP21
of
Temperature: +5℃～+40℃;
Operating
Environment
Humidity: ≤93%
Pressure: 70.0kPa～106.0kPa
About
112g
batteries)
(Without
Pulse: ±5%
Temperature: -25℃～+70℃;
Storage
Environment
Humidity: 10%～95%
Pressure: 50.0kPa～106.0kPa
Altitude: ≤ 3 000 m
Weight
Pressure: ±3mmHg (±0.4kPa)
Size
75mm×57mm×34mm
·2 AAA Alkaline Batteries
·Storage Case (Optional)
Contents
Type BF
·Instruction Manual
·Guarantee Card
This unit is intended for home use and the specification may be changed without prior notice.
Please dispose of the batteries according to local regulations.
Protection
Against
Electric Shock
Rev. A1
Important information regarding Electro Magnetic Compatibility (EMC)
With the increased number of electronic devices such as PC’s and mobile (cellular) telephones,
medical devices in use may be susceptible to electromagnetic interference from other devices.
Electromagnetic interference may result in incorrect operation of the medical device and create
a potentially unsafe situation.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to
prevent unsafe product situation, the IEC60601-1-2 standard has been implemented. This
standard defines the levels of immunity to electromagnetic interferences as well as maximum
levels of electromagnetic emissions for medical devices.
This medical device manufactured by pump conforms to this IEC60601-1-2:2007 standard for
both immunity and emissions.
Nevertheless, special precautions need to be observed:
·Do not use mobile (cellular) telephones and other devices, which generate strong electrical or
electromagnetic fields, near the medical device. This may result in incorrect operation of the
unit and create a potentially unsafe situation. Recommendation is to keep a minimum distance
of 7 m. Verify correct operation of the device in case the distance is shorter.
Further documentation in accordance with IEC60601-1-2:2007 is available at pump at the
address mentioned in this user manual.
Guidance and manufacturer’s declaration
Guidance and manufacturer’s declaration – electromagnetic emissions
The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment
specified below. The customer or the user of the [EQUIPMENT or SYSTEM] should assure that
it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Compliance
Group 1
Electromagnetic environment - guidance
The [EQUIPMENT or SYSTEM] uses RF energy
only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
Class B
Not applicable
Not applicable
Guidance and manufacturer’s declaration – electromagnetic immunity
The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment specified
below. The customer or the user of the [EQUIPMENT or SYSTEM] should assure that it is used
in such an environment.
Immunity
IEC 60601 test
Compliance
Electromagnetic environment test
level
level
guidance
Electrostatic
Floors should be wood, concrete or
discharge
±6 kV contact
±6 kV contact ceramic tile. If floors are covered with
(ESD)
synthetic material, the relative humidity
±8 kV air
±8 kV air
IEC
should be at least 30%. If ESD interfere
61000-4-2
with the operation of equipment, counter
10
Rev. A1
measurements such as wrist
grounding shall be considered.
Electrical fast
transient/burst
IEC
61000-4-4
Surge
IEC
61000-4-5
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC
61000-4-11
Power
frequency
(50/60
Hz)
magnetic
field
IEC
61000-4-8
±2 kV for power
supply lines
± 1 kV for
input/output lines
±
kV
differential mode
± 2 kV common
mode
< 5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
< 5% UT
(>95% dip in UT)
for 5 sec
3 A/m
Not applicable
Not applicable
strap,
Mains power quality should be that of a
typical
commercial
or
hospital
environment.
Mains power quality should be that of a
typical
commercial
or
hospital
environment.
Not applicable
Mains power quality should be that of a
typical
commercial
or
hospital
environment. If the user of the
[equipment or system] requires continued
operation
during
power
mains
interruptions, it is recommended that the
[equipment or system] be powered from
an uninterruptible power supply or a
battery.
3 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
Guidance and manufacturer’s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEMS that are not LIFE – SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment
specified below. The customer or the user of the [EQUIPMENT or SYSTEM] should assure that
it is used in such an environment.
IEC 60601 test
Compliance
Electromagnetic environment Immunity test
level
level
guidance
Conducted RF
3 Vrms
3V
Portable
and
mobile
RF
IEC 61000-4-6 150 kHz to 80 MHz
communications equipment should be
used no closer to any part of the
Radiated RF
3 V/m
3V/m
[EQUIPMENT or SYSTEM], including
IEC 61000-4-3 80 MHz to 2.5 GHz
cables,
than
the
recommended
separation distance calculated from the
equation applicable to the frequency or
the transmitter.
Recommended separation distance
d = 1.2
d = 1.2
p 80 MHz to 800 MHz
p 800 MHz to 2.5 GHz
d = 2.3
Where P is the maximum output power
rating of the transmitter in watts (W)
according
to
the
transmitter
manufacturer and d is the recommended
11
Rev. A1
separation distance in meters (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.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Recommended separation distances between portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM –
For EQUIPMENT and SYSTEMS that are not LIFE – SUPPORTING
Recommended separation distances between portable and mobile RF communications
equipment and the [EQUIPMENT or SYSTEM]
The [EQUIPMENT or SYSTEM] is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the [EQUIPMENT or
SYSTEM] can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the [EQUIPMENT
or SYSTEM] as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter
Rated maximum
output power of
80 MHz to 800 MHz
800 MHz to2.5 GHz
150 kHz to 80 MHz
transmitter
d = 1.16 p
d = 2.33 p
d = 1.16 p
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (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.
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-BFY
12
Rev. A1
The device has been evaluated to meet general RF exposure requirement. The device can be used in
portable exposure condition without restriction.
8．About Blood Pressure
8.1 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.
8.2 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
Category
Systolic (mmHg)
Diastolic (mmHg)
Desirable
<120
Pre hypertension
120-139
and/or
80-89
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
and
<80
These categories were defined by the American Heart Association. This chart applies to adults
age 20 and older.
13
Rev. A1
8.3 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 celebral 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 Medical electrical equipment-Part1: General requirements for safety and
essential performance.
·IEC 60601-1-2:2007 Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
· EN 1060-1:1995+A2:2009 Non-invasive sphygmomanometers – parts1: General
requirements
· EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers – parts3: Supplementary
requirements for electro-mechanical blood pressure measuring systems.
· ANSI/AAMI SP-10:2002+A1:2003+A2: 2006/(R)2008 Manual, electronic, or automated
sphygmomanometers
·ANSI/AAMI/ISO 81060-2-2009 Non-invasive sphygmomanometers-Part 2:Clinical validation of
automated measurement type
14
Rev. A1
Blood Pressure Measurement Chart
Date
Time
SYS/DIA
Pulse
Remark
Date
Time
SYS/DIA
Pulse
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.
·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 who 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.
15
Remark
Rev. A1
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
Certificate
Product Name: Blood Pressure Monitor
Product Model: BF2214(0B)
Notes:
Symbol for "batch code”
Symbol for "manufacturer"
0123 Symbol for“CE“
Symbol for “Follow operating instructions”
Symbol for”TYPE BF APPLIED PART”
IP21 Symbol for “the IP classification”
Symbol for “electrical and electronic equipment“
Symbol
for
"AUTHORISED
REPRESENTATIVE
IN
THE
EUROPEAN
COMMUNITY"
After-Sale Service
Manufacturing Enterprises: Shenzhen Pump Medical System Co., Ltd.
ADD: 2/F West, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan
District, Shenzhen 518057, China
Tel: 86-0755-26710795/26067119
Fax: 86-0755-26012025
Service Line: 86-4006 755 009
E-mail: service@bpump.com.cn
Shanghai International Trading Corp. GmbH (Hamburg)
Address: Eiffestrasse 80, 20537 Hamburg, Germany
16

---

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