PUMP MEDICAL SYSTEM BW6004B Arm Automatic Blood Pressure Monitor User Manual EN BW6004B Instruction Manual A1

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Rev. A1
Arm Automatic Blood Pressure Monitor
Instruction Manual
BW6004B
Table of Contents
1. Safety Information ................................................................................................... 2
1.1 Warning.............................................................................................................................. 2
1.2 Precaution .......................................................................................................................... 2
2. Product Feature ....................................................................................................... 3
3. Pre Measurement ..................................................................................................... 5
3.1 Battery ................................................................................................................................ 5
3.2 Power Adapter（Optional） ............................................................................................ 5
3.3 System Setting ................................................................................................................... 6
4 Take a measurement ................................................................................................. 7
4.1 Important Noted ................................................................................................................ 7
4.2 Fitting the cuff ................................................................................................................... 7
4.3 Body posture during measurement.................................................................................. 8
4.4 Take Measurement ............................................................................................................ 8
4.5 Data Transmission ............................................................................................................. 9
4.6 Memory ............................................................................................................................ 10
5. Error Indication ..................................................................................................... 10
6. Trouble Shooting .................................................................................................... 11
7. Specification ........................................................................................................... 11
8．About Blood Pressure .......................................................................................... 15
8.1 What is Blood Pressure? ................................................................................................. 15
8.2 What is high blood pressure? ......................................................................................... 15
8.3 What is morning hypertension (morning surge)? ........................................................ 16
Reference Standard.................................................................................................... 16
Blood Pressure Measurement Chart ........................................................................ 17
Guarantee Card ......................................................................................................... 17
Product label............................................................................................................... 18
Explanation of Symbols ............................................................................................. 18
After-Sale Service....................................................................................................... 18
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.
•
Only take measurement with the manufacturer supplied cuff or AC adapter, or else it will lead
to inaccurate results.
•
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 the inaccurate measurement.
•
When using or replacing the AC adapter and batteries, the operator not to 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 or hand cuff.
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 cleaning the cuff with water.
Clean the cuff with soft dry cloth after measurement.
Rev. A1
•
Do not use at extremely high temperature, high humidity, or high altitude. Use only within the
required ambient conditions.
•
•
•
•
•
•
Do not place heavy objects on the AC adapter cable, or allow the unit to sit on the cord.
Do not plug in or unplug the AC adapter with wet hands.
Do not drop or expose the device to heavy shock.
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.
•
This product is suitable for use to self- monitoring of blood pressure in home or used by the
licensed healthcare personnel in hospital.
Precaution！Please read the enclosed instruction。
2. Product Feature
Scope：Measurement of Human Blood Pressure and Pulse Rate for adults
Body
Fig 1
Rev. A1
Cuff (Type BF Applied Part)
Model：BC1000/BC8000
Applicable Arm Circumference: 220 mm to 360mm
TYPE:BC1000
Cuff Label
Fig 2
Note:
Symbol for”TYPE BF APPLIED PART”
Display
Rev. A1
Fig 3
3. Pre Measurement
3.1 Battery
3.1.1 Installation and replacement
1） Remove battery cover
2） Load 4 standard AA alkaline battery as indicated in Fig 4.
Fig 4
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 4 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
•
Four 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.
•
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 Power Adapter（Optional）
1)
2)
Connect the AC adapter to the AC adapter connector of the main unit
Plug the socket into electric outlet.( Fig 5)
•
AC adapter model: UE08WCP-060050SPA
Rev. A1
•
Use the correct adapter designed for your local
voltage (AC 100~240 V)
•
Do not plug in multiple plugs into same power
outlet.
•
Power adapter specification: Input: AC 100~240 V,
50/60Hz, 400mA; Output: 6.0V
0.5A
•
•
Use the manufacturer power adapter only.
Unplug the AC adapter or wires if the device is
damaged.
•
•
Do not touch the AC adapter with wet hand.
When operating the unit please do not tangle the
power cords.
Electric Outlet
AC adapter
AC adapter connector
Fig 5
3.3 System Setting
3.3.1 Setting
1)
2)
3)
With monitor power off
Press the【S】button into the setting mode, and Year digits blinking
a) Change number
ⅰPress the 【M】 button to advance one number
ⅱHold down the 【M】button, the number will change rapidly
b) Enter the digit of the year number
c) Press the【S】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 memory button will automatically change the unit conversion either from
mmHg or kPa as shown on Fig 6 or Fig 7.
b) Complete setting, press【ON/OFF】button to exit.
Fig 6
Fig 7
3.3.2 Memory Data Conversion
The blood pressure monitor is capable to hold 2 sets of memory data. Prior using the blood
pressure monitor, select the correct memory data.
Memory data conversion:
With monitor power off, hold the【ON/OFF】button until the selected Memory
displayed.
Rev. A1
Press the 【ON/OFF】button will automatically change the memory data conversion
either from Memory 1 or Memory 2.
The machine is complete setting, ready to use.
4 Take a measurement
4.1 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.
4.2 Fitting the cuff
1)
2)
3)
Plug in the air tube connector into the main unit
Wrap the cuff around the upper left arm or upper right arm.
Tighten the cuff around the arm, make sure the cuff is approximately 2～3cm ( 1～2 inches)
above the elbow.（Fig 8）
4)
5)
Fig 8
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.
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.
Rev. A1
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
4.3 Body posture during measurement
Relax, place the elbow on the desk with palm facing up; cuff should be at the heart level (Fig
9). 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 9
4.4 Take Measurement
After installing the batteries and wearing the cuff, the unit is ready for measurement:
1)
2)
3)
4)
5)
6)
7)
8)
9)
For the most accurate result please relax, do not smoke, take deep breath, speak loudly
or move around during the measurement.
Turn on the 【ON/OFF】 button; display will lit-up for 1 second as shown on Fig 10.
Then the display on switch to Fig 11, a beep sound indicates the monitor has begun
taking the measurement.
When the device detects a pulse, the heart symbol will flash as shown on Fig 12. The
cuff inflates, and your pulse and blood pressure measurement is taken.
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.
When completing the test, the cuff will automatically deflate and the test result will
display on the screen as shown on Fig 13 and the device will broadcast the result. And
the LED indicator in the right of the display and LED light will indicate the level of the
blood pressure. The blood pressure level classification and definition as show in Fig 14.
You may turn off the unit or compare with the previous results
Automatic shut off in 3 minutes.
If a problem occur during the test, “Err ” will display on the screen.
10) In the end of measurement, “
” will display on the screen when irregular pulse is
detected.
Rev. A1
Fig 10
Fig 11
Fig 12
Fig 13
The blood pressure level classification and definition (Fig 14)
Fig 14
Notes:
•
•
•
Do not self-diagnosis according to measurement results. Follow the instructions of your
physician or licensed healthcare provider.
The LED indicator in the right of the display and LED light will indicate the level of the blood
pressure. The red LED light indicate the hypertension, and the green LED light indicate the
normal pressure. The blood pressure level classification and definition as show in Fig 14.
If the device caused 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
Rev. A1
The Bluetooth is turn on after the device connected to the AC adapter or installed the batteries, the
device can transmit the data to the data management system by Bluetooth.
4.6 Memory
The Memory 1 and Memory 2 can hold up to 60 reading each.
1) Memory Review
a) With monitor power off, hold the 【M】button to enter the memory mode.
b) The unit will display the most recent 3 set of data average
c) When holding the【M】button the user can view the data from the most recent date to the
oldest date. When holding the【S】button the user can view vice versa.
d) If the user need to display the other set of memory data please refer to section 3.3.2
e) If the data in memory displays the heart mark, it prompts when measurement the irregular
pulse is detected.
Caution: Continuous holding the 【M】button will delete all the memory.
2) Delete memory data
a) Enter into the memory mode refer to section 3.3.2
b) Press and hold the memory button until the “---” displayed, all the memory data will be
deleted
c) The unit will only delete the present set of memory data; the other set of memory data
will not be affected.
d) The device is not capable of deleting a single data.
e) Press the 【ON/OFF】 button exit the memory mode and turn off.
5. Error Indication
List of Error code.
Error
Cause
How to correct
Heavy shock during the
measurement.
Bad Signal，moving or talking
during the measurement.
（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 4), retake the
measurement
Cuff too loose，Confirm the cuff is
wrapped up correctly（ref 4.2）retake the
measurement
Remain still, retake the measurement (ref
4.1）
Remain still, retake the measurement (ref
4.1）
Er7
Measurement abnormal.
Please retake the measurement.
Lo
Low battery power, cannot inflate
Change battery（ref 3.1）
Cuff
self-test
symbol
Er 2
Er 3
Er 5
Power on, cuff inflation rate is too
low or main unit does not connect
with the cuff.
Weak Signal or cuff is too loose
10
Rev. A1
6. Trouble Shooting
When the unit encounters malfunction during the use, refer to table below:
Abnormal
How to correct
（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 are abnormally
measurement
high or low
（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 （1） Reconnect the air tube connector with the main unit
（2） Cuff or bladder leakage, if necessary purchased a
does not inflate
new one.
（1）
Cuff too loose，confirm the cuff is wrapped up
Cuff deflates too quickly.
correctly。
（1） Blood pressure value is varied during the day which
Measure value is different from the
also will affect by the human emotional and physical
hospital or the value is inconsistent
condition
（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.
After batteries installation, power
on, no display.
7. Specification
Description
Arm automatic blood pressure monitor
Model
BW6004B
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
2 Memory sets, 60 reading each set.
Automatic
power off
Unattended 3 minutes
Battery Life
Approx 200 measurements
IP classification
IP21
Storage
Temperature：-25℃～+70℃；
Power source
Protection
against electric
shock
Operating
4 AA Alkaline battery
AC Adapter（AC 100~240 V）
Type BF
Temperature：+5℃～+40℃；
11
Pressure : ±3mmHg
（±0.4kPa）
Pulse: ±5%
and
Rev. A1
Environment
Humidity：≤93%
Pressure: 70.0kPa～106.0kPa
transport
Environment
Humidity：10%～95%
Size
140 mm×116mm×81 mm
Contents
·Cuff(Applicable arm circumference:
220mm to 360mm)
·AC Adapter（Optional）
·4 A A alkaline batteries
·Storage case (Optional)
·Instruction Manual
Pressure:50.0kPa～106.0kPa
Altitude: ≤ 3 000 m
Weight
Life
(Body)
360g（Without batteries）
time
Body
five years or 10000
times
Cuff
10000 times
AC
Adapter
50000 hours
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.
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
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.
12
Rev. A1
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
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
Floors should be wood, concrete or
Electrostatic
ceramic tile. If floors are covered with
discharge
synthetic material, the relative humidity
±6 kV contact
±6 kV contact
(ESD)
should be at least 30%. If ESD interfere
±8 kV air
±8 kV air
IEC
with the operation of equipment, counter
61000-4-2
measurements such as wrist strap,
grounding shall be considered.
Electrical fast ±2 kV for power
Mains power quality should be that of a
transient/burst supply lines
Not applicable
typical
commercial
or
hospital
IEC
± 1 kV for
environment.
61000-4-4
input/output lines
±
kV
Mains power quality should be that of a
Surge
differential mode
typical
commercial
or
hospital
IEC
Not applicable
environment.
±
kV
common
61000-4-5
mode
< 5% UT
(>95% dip in UT)
Voltage dips,
Mains power quality should be that of a
for 0.5 cycle
short
typical
commercial
or
hospital
40% UT
interruptions
environment. If the user of the
(60% dip in UT)
and voltage
[equipment or system] requires continued
for 5 cycles
variations on
Not applicable
operation
during
power
mains
70% UT
power supply
interruptions, it is recommended that the
(30% dip in UT)
input lines
[equipment or system] be powered from
for 25 cycles
IEC
an uninterruptible power supply or a
< 5% UT
61000-4-11
battery.
(>95% dip in UT)
for 5 sec
Power
frequency
Power frequency magnetic fields should
(50/60
Hz)
be at levels characteristic of a typical
3 A/m
3 A/m
magnetic
location in a typical commercial or
field
IEC
hospital environment.
61000-4-8
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
13
Rev. A1
it is used in such an environment.
Conducted RF
IEC 61000-4-6
IEC 60601 test
level
3 Vrms
150 kHz to 80 MHz
Compliance
level
3V
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3V/m
Immunity test
Electromagnetic environment guidance
Portable
and
mobile
RF
communications equipment should be
used no closer to any part of the
[EQUIPMENT or SYSTEM], including
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
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
10
0.38
1.2
3.8
0.38
1.2
3.8
0.73
2.3
7.3
14
Rev. A1
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.
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.
According to World Health organization standard, the blood pressure level classification and
definition as following:
Category
Systolic（mmHg）
Diastolic（mmHg）
Desirable
<120
<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
and
15
Rev. A1
These categories were defined by the American Heart Association. This chart applies to adults
age 20 and older.
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
16
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 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.
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
Certificate
Product Name: Arm Automatic Blood Pressure Monitor
Product Model: BW6004B
Inspector:
17
Remark
Rev. A1
Product label
Explanation of Symbols
Symbol for “batch code”
Symbol for “manufacturer”
0123
Symbol for “CE”
Symbol for “Follow operating instructions”
Symbol for “TYPE BF APPLIED PART”
Symbol for “electrical and electronic equipment”
IP21
Symbol for “the IP classification”
Symbol
COMMUNITY”
for
“AUTHORISED
REPRESENTATIVE
IN
THE
EUROPEAN
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：86-755-26710795/26067119
Fax：86-755-26012025
Service Line：86-4006 755 009
E-mail：service@bpump.com.cn
Shanghai International Trading Corp. GmbH (Hamburg)
18
Rev. A1
Address: Eiffestrasse 80, 20537 Hamburg, Germany
19

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