VER:A00
Distributor:
Thanks for choosing the Digital Blood Pressure Monitor.
Please read this instruction manual before using your unit.
Please keep this instruction manual safe for future use.
Model No:BW2110
Fully Automatic Wrist Style
Digital Blood Pressure Monitor
Instruction Manual
Introduction ...............................................................................................1
Symbols Use .............................................................................................2
Important Safety Notes..............................................................................3
Konw Your Unit ......................................................................................4-5
IHB Introduction ........................................................................................6
Before Taking A Measurement ..................................................................7
Battery lnstallation/Replacement ............................................................8-9
Adjusting Settings ....................................................................................10
Proper Way of Measurement ...................................................................11
Take a Measurement ..........................................................................12-13
Use the Memory Function
To read the average value ...................................................................14
To read the measurement value ..........................................................15
To delete the memory value .................................................................16
About Blood Pressure
Blood Circulation ..................................................................................17
Health and Blood Pressure ..................................................................18
Classification of Blood Pressure .....................................................19-20
Before Using the Monitor
Care and Maintenance
Operating Instructions
Table of Contents
Exceptional Situations
Error Indicators ....................................................................................21
Eliminate Fault .....................................................................................22
Care and Maintenance
Care .....................................................................................................23
Maintenance ........................................................................................24
Specifications .....................................................................................25-26
Statement ................................................................................................27
Warranty Information ..........................................................................28-36
Table of Contents
2
Important Safety Notes
Read all information in the instruction manual and any other
literature included in the box before using the unit.
Contact your physician for specific information about your blood pressure.
Self-diagnosis and treatment using measured results may be dangerous.Follow
the instructions of your healthcare provider.
Operate the unit only as intended. Don't use for any other purpose.
The unit is intended to use in measuring blood pressure and pulse rate for adult
only, not recommended for neonatal baby at home or medical centre.
Do not use a cellular phone near the unit. It may result in operational failure.
Please avoid using in high radiant area in order to make your measuring data
correctly.
Do not disassemble or attempt to repair the unit or components.
Do not use the equipment where flammable gas (such as anesthetic gas,
oxygen or hydrogen) or flammable liquid (such as alcohol) are present.
To assure the correct use of the product basic safety measures
should always be followed including the precautions listed below:
3
Symbols Use
Indicates a potentially hazardous situation
Type B applied part
Refer to instruction manual/booklet
MANUFACTURER
SERIAL NUMBER
The marking of electrical and electronics devices
according to Directive 2002/96/EC.
The device,accessories and the packaging have to be disposed
of waste correctly at the end of the usage.
Please follow Local Ordinances or Regulations for disposal.
AUTHORISED REPRESENTATIVE IN THE
EUROPEAN COMMUNITY
which, if not
avoided, could result in death or serious injury.
SYMBOLS USED IN THIS INSTRUCTION MANUAL
WARNING
CAUTION
Indicates a potentially hazardous situation which, if not
avoided, may
result in minor or moderate injury to the user or
patient or damage to the equipment or other property.
1
Introduction
Thank you for purchasing Fully Automatic Wrist Style Digital Blood Pressure
Monitor.
The unit uses the oscillometric method of blood pressure measurement. It
means the unit detects the movement of your blood through your brachial
artery, and converts your blood pressure into a digital reading. The unit is
simple to use because a stethoscope is not needed while using an
oscillometric monitor.
The unit stores automatically 60 sets of measurement values . You can read
the stored data conveniently by pressing the memory button.
The unit comes with the following components:
• Main Unit
• Storage Case
• Instruction Manual printed in English
Body & Cuff
4
Know Your Unit
fWrist Cuf
Battery Compartment
Start/Stop Button
Memory Button
Memory Button
Display
Initialization
Initialization
Battery Installation / Replacement
1
Remove the battery cover from the
battery compartment.
2
8
Install 2 “AAA” size batteries so the + (positive)
and - (negative) polarities match the polarities
of the battery compartment as indicated.
2 AAAAlkaline
Batteries
Power
Display
Storage Case
5
Know Your Unit
When the unit detects an irregular rhythm two or more times during the
measurement, the Irregular Heartbeat Symbol will appear on the
display with the measurement values.
An irregular heartbeat rhythm
is defined as a rhythm that
varies by less than 25%
from the average rhythm
or 25% more than the
average rhythm detected
while the monitor is
measuring the systolic and
diastolic blood pressure.
If the Irregular Heartbeat Symbol ( ) displays with your measurement
results, we recommend you consult your physician.
Follow the directions of your doctor.
6
IHB Introduction
Normal Heartbeat
Irregular Heartbeat
Pulse
Blood
pressure
Pulse
Blood
pressure
Short Long
Irregular Heartbeat Symbol ( )
1.Avoid eating,drinking alcohol, smoking, exercising and bathing for
30 minutes before taking a measurement.
2.Stress raises blood pressure.Avoid taking measurements during
stressful times.
3.The cuff can be applied to your left or right wrist.Always measure
your blood pressure on the same wrist.
4.Measurements should be taken in a quiet place.
5.Position the unit at heart level throughout the measurement.
6.Remain still and do not talk during the measurement.
7.Keep a record of your blood pressure and pulse readings for your
physician.A single measurement does not provide an accurate
indication of your true blood pressure.You need to take and record
several readings over a period of time.Try to measure your blood
pressure at the same time each day for consistency.
8.Wait 30~60 seconds between measurements.The wait time allows
the arteries to return to the condition prior to taking the blood
pressure measurement.You may need to increase the wait time
depending on your individual physiological characteristics.
7
Before Taking A Measurement
Unit lndication
Systolic Blood
Pressure
Diastolic Blood
Pressure
Heartbeat Symbol
Pulse
Memory & Times
Irregular Heartbeat
Symbol
Low Battery Symbol
Average Value Symbol
Inflation/Deflation Symbol
or WHO Indication
Adjusting Settings
10
Replace the battery cover.
Caution!
3
Battery Installation / Replacement
9
Use two identical 1.5V alkaline batteries type
AAA/LR03.
Do not use rechargeable batteries.
Replace both of the batteries if the symbol of
low battery appears on the display.
Never leave any low battery in the battery
compartment since they may leak and cause
damage to the unit.
Press the “MEM” down button about 10 seconds unil the units (kPa or
mmHg) displayed when the unit turned off.
Then press the “MEM” up button to change the current unit.
Press the “START/STOP” button to save the current setting and turn off.
11
Proper Way of Measurement
1
Wrap the cuff tightly
around your wrist by
using the Velcro strip.
2
Sit in a chair with your feet flat on the floor.
3
Remove all clothes from your
arm allowing the cuff to fit
directly on the skin.
Start to inflateDeflating automatically
All symbols display
Measurement starts while inflating.
2
The hearbeat symbol “ ” flashes once a pulse is detected.
To a fit pressure
Continue InflatingHeartbeat appearInflatingStart to inflate
All display symbols appear.
12
Take a Measurement
Press the “
START/STOP
” button.
1
1cm
(0.4'')
13
Take a Measurement
Press the “
START/STOP
” button to turn off the unit.
4
The cuff is deflated automatically,
and the measurement results are
stored in memory with date and
time
The “ ” symbol will be displayed
if irregular heartbeat is deteced.
The blood pressure and pulse rate are displayed when the
measurement completed.
3
“kPa”display
“mmHg”display “ ”display
“ ”display
The unit will automatically turn off after two
minutes if you have forgotten to turn it off.
NOTE:
To stop the inflation or measurement, press the
“
START/STOP
” button in anytime. The unit will
stop inflating and then release and turn off.
OR OR
The unit also calculates an average reading based on the values of the
latest 3 times measurement taken.
Press the “MEM” up button, the average value of
the latest 3 times
measurement taken
of the current user will display with the average reading.
Use the Memory Function
14
To read the average value
...................................
the average value of the latest
3 times measurement taken
Turn to next
The unit stores the blood pressure and pulse rate in the memory after
completing a measurement every time. It can automatically store 60 sets of
measurement values . The oldest record is deleted to save the latest
measurement value when more than 60 sets.
15
Use the Memory Function
..............................................
To read the measurement value
Press the “MEM” up button to display the set of measurement values.
Press the “MEM” down button to display the next set of measurement values.
After the measurement finished and when reading the memory values,
the backlight is on about 10 seconds.
16
Use the Memory Function
To delete the memory value
..............................................
In the memory reading mode,
press
the “MEM” down button for 4-6 seconds, the unit
will display “ ”.
Press the “MEM” up button and confirm “ ” or “ ”.
If you are sure all the data of corresponding user can be deleted, press the
“START/STOP” button, all the corresponding user’s data will be deleted and
the unit will turn off.
Note: If you have set “ ”, but do not press a button for 2 minutes, the unit will
turn off automatically, but the corresponding user’s blood pressure data will not
be deleted. The delete operation must be confirmed by user.
The 1st latest
measurement value
The 2nd latest
measurement value
The 60th latest
measurement value
Backward
Forward
17
About Blood Pressure
Lower pressure
Relaxation of the
heart muscle
Pressure decreased
to the blood vessel
Blood return heart
Higher pressure
Contraction of
the heart muscle
Pressure increased
to the blood vessel
Extrude blood
Diastolic Blood PressureSystolic Blood Pressure
Blood Circulation
The blood circulation is responsible for supplying the body with oxygen.
blood pressure is the pressure exerted on the arteries.
The systolic blood pressure value (higher pressure or top value) represents
the blood pressure produced by contraction of the heart muscle.
The diastolic blood pressure value (lower pressure or lower value) represents
the blood pressure produced by relaxation of the heart muscle.
18
About Blood Pressure
The incidence of hypertension increases with age. In addition, a lack of exercise,
excess body fat and high levels of cholesterol (LDL), which sticks to the inside in
blood vessels, reduces elasticity of these vessels. Hypertension accelerates arterial
sclerosis which can lead to very serious conditions such as stroke and myocardial
infarction. For these reasons it is very important to know whether the blood
pressure is within a healthy range. Blood pressure fluctuates from minute to minute,
throughout the day. Therefore it is essential to take regular measurements to help
you identify an average blood pressure.
19
About Blood Pressure
*Note!
When a person’s systolic and diastolic pressures fall into different categories, the
higher category should apply.
WHO
80
85
90
100
110
Diastolic Blood Pressur (mmHg)
120 130 140 160 180
Systolic Blood Pressure (mmHg)
Optimal
blood pressure
(target value)
Normal blood pressure
Normal systolic value
Mild hypertension
Moderate hypertension
Severe hypertension
After each measurement is completed, the LCD display will show your position
automatically on the six segments of the bar indicator which corresponds to World
Health Organization (WHO) Blood Pressure Indicator.
Reference Material: Journal of Hypertension 1999, Vol 17 No.2
Classification of Blood Pressure
High blood pressure can go unnoticed
for a long time, since it doesn’t cause
noticeable symptoms. The following
are all possible causes of abnormally
high blood pressure:
Overweight;
High cholesterol level;
Smoking;
Excessive alcohol consumption;
Stress and emotional upset;
Excessive consumption of salt;
Lack of physical exercise;
Genetic / hereditary predisposition;
Underlying illnesses, such as kidney
disorders or endocrine disturbance.
If your blood pressure reaches upper
values of 140~160 mmHg and lower
values of 90~95 mmHg in repeated
measurements over several days, you
should consult your doctor for detailed
medical examination. You can assist
the treatment prescribed by your
doctor in the following ways:
Loose weight and lower your
cholesterol level;
Reduce the consumption of alcohol;
Reduce the intake of salt;
Stop smoking;
Take regular exercise;
Monitor your blood pressure.
20
About Blood Pressure
Classification of Blood Pressure
21
Exceptional Situations
Wrap the cuff correctly and tightly.
Inflate over again after ensuring.
Measure over again according to
correct way.
Do not move your arm and body,
and keep quiet.
When the batteries
power are too low.
The course of
inflating appears
error.
When measurement
fails.
Correction
CauseSymbol
Error Indicators
Replace both of the worn batteries
with two new ones.
The following symbol will appear on the display when measuring abnormally.
22
Exceptional Situations
Blood pressure varies constantly. Many
factors including stress, time of day, how
you wrap the cuff, may affect your blood
pressure. Review the sections "Proper
Way of Measurement" and "Take a
Measurement".
Check the battery installation for proper
placement of the batteries polarities.
Measurement values
appear too high or too low.
No display appears on the
display screen.
No power.
Causes and Solutions
Problem
Eliminate Fault
Replace both of the worn batteries
with two new ones.
23
Care and Maintenance
Care
Avoid subjecting the monitor to strong shocks or vibrations, such as dropping
the nuit on the floor.
Use the unit consistent with the instructions provided in this manual.
Use only authorized parts and accessories.
Keep the unit in the storage case
when not in use.
Clean the unit with a soft dry cloth.
Do not use any abrasive or volatile
cleaners.
Never immerse the unit or any
components in water.
Store the unit in a clean and dry
location. Do not subject the unit to
extreme hot or cold temperature,
humidity and direct sunlight.
Maintenance
24
Care and Maintenance
naphtha
thinner
gasoline
Remove the batteries if the unit will
not be used for 3 monthes or longer.
Always replace both of the batteries
with new ones at the same time.
Do not wet the cuff or attempt to clean
the cuff with water.
Do not clean the body and cuff with
naphtha, thinner or gasoline etc.
60 Sets Measurement Values
25
Specifications
BW2110
LCD Digital Display
Oscillometric Method
Measurable
Model No.
Display
Measuring Principle
Circumference of Wrist
13.5~21.5cm
(5.3''~8.5'')
Electric Shock
Protection
Measurement
Range
Accuracy
Pressure
Pulse
Pressure
Pulse
Pressure
0 to 299 mmHg (0~39.9 kPa)
40 to180 Pulses/min
3 Digits Display of mmHg or kPa
3 Digits Display
Memory/IHB/Heartbeat/Low Battery,etc.
3 mmHg (0.4kPa)
5% of reading
Pulse
Internal power supply appliance type B
LCD
Indication
Symbol
26
Specifications
10 ~ 40 C (50 ~ 104 F)
15 ~ 90%RH (Noncondensing)
-20 ~ 60 C (-4 ~ 140 F)
10 ~ 95%RH (Noncondensing)
Temperature
Humidity
Temperature
Humidity
Barometric Pressure
Automatic by Internal Pump
Automatic by Air Valve
In 2 Minutes
Approx. 87*84*36mm
Operating
Environment
Memory Function
Inflation
Power Source
Rapid Air Release
Automatic Power-Off
Dimensions
Approx. 110g (Batteries not included)
Gross Weight
80~105 kPa
2 AAA Alkaline Batteries
28
27
Warranty Information
Federal law restricts this device to sale by or on the order of a physician.
Unit subjected to misuse, abuse, and neglect of these manual contents,
non-instructional purposes;unauthorized repair or modifications will be excluded
from this warranty. This guarantee specifically excludes expendables and
consumables, for example batteries.All warranty claims must be directed to the
distributor responsible for the sale of the device. The content of this warranty is
subject to change without further notice.
For repair under this warranty.Our authorized service agent must be advised of
the fault within the period of the warranty.This warranty covers parts and labor
only under normal operations.A transportation fee or freight fee that may be
incurred will be the owner’s responsibility.Any defect resulting from natural
causes, e.g.,flood,hurricane etc., is
not within this guarantee.
This guarantee does not cover damage incurred by use of the unit not in
accordance with the instructions, accidental damage, or being tampered with or
serviced by unauthorized service agents.
The unit, excluding the unit cuff, is guaranteed to be free of defects in
workmanship and materials for a period of two years from the date listed on the
purchase record, when used in accordance with the instructions provided with the
unit.The unit cuff is warranted to be free from defects in materials and
workmanship appearing within one year from the date listed on the purchase
record when the unit is used in accordance with the instructions provided with the
unit.
Statement
The intended use: The unit is intended to be used by adults at home or medical
centre to measure blood pressure and pulse rate.
The unit satisfies the requirements of IEC60601-1 Medical electrical equipment,
EN1060-1: Non-invasive sphygmomanometer, EN1060-3: Non-invasive
sphygmomanometer,IEC80601-2-30: Medical electrical equipment.
The unit has passed the EMC Test.
Blood pressure measurements determined with this device are equivalent to
those obtained by a trained observer using the cuff/stethoscope auscultatory
method, within the limits prescribed by the American National Standard,
Manual, electronic, or automated sphygmomanometers.
The risk of patient and user can be lowered to acceptable level.
Substitution of a cuff different from that supplied might result in measurement error.
Please contact us if you need the circuit diagrams, component part lists etc.
Specifications are subject to change without notice due to improvements in
performance.
Transport and
Storage
Environment
29
Warranty Information
Periodical check:
Sensitive measuring devices must be checked from time to time for accuracy
and leakage, we therefore recommend that the performance should be checked
every 2 years and after maintenance and repair.
Please contact the local distributor for details.
The unit satisfies the requirements of EN60601-1： Medical electrical
equipment Part 1: General requirements for basic safety and essential
performance; EN60601-1-2: Medical electrical equipment Part 1-2:General
requirements for basic safety and essential performance – Collateral standard:
Electromagnetic compatibility – Requirements and tests;
EN1060-1:Non-invasive sphygmomanometers – Part 1: General requirements;
EN1060-3: Non-invasive sphygmomanometers – Part 3: Supplementary
requirements for electro-mechanical blood pressure measuring system.
EN1060-4：Non-invasive sphygmomanometers – Part 4: Test procedures
to determine the overall system accuracy of automated non-invasive
sphygmomanometers.
Warning: Do not use luer lock connector 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.
30
Warranty Information
It can’t be used while the wrist (arm) has bleeding or wound to avoid the blood
flowing from the wound in pressurizing.
It can’t be used while the wrist (arm) has bleeding or wound to avoid the blood
flowing from the wound in pressurizing.
WARNING: No modification of this equipment is allowed.
Clean the cuff with a soft dry cloth.
Applied parts contains cuff.
The device，accessories and the packaging have to be disposed of waste
correctly at the end of the usage. Please follow Local Ordinances or
Regulations for disposal.
Protection Class: Internally powered equipment
Applied Part Type: Type B
Moisture Protection: IPX0, continue operation
Manufacturer will make available on request circuit diagrams, component
part lists etc for the service personnel in parts repair.
32
Guidance and manufacture’s declaration – electromagnetic emission
Emission test
RF emission
Harmonic
Voltage
Group 1
Class B
Not applicable
Not applicable
The Digital Blood Pressure Monitor use 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.
The Digital Blood Pressure Monitor is suitable for use in all
establishments other than domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
CISPR 11
RF emissions
emissions
fluctuations/
flicker emissions
IEC 61000-3-3
IEC 61000-3-2
CISPR 11
Compliance
Electromagnetic environment – guidance
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment
specified below. The customer of the user of the Digital Blood Pressure Monitor should
assure that it is used in such an environment.
31
Warranty Information
Guidance and manufacture’s declaration
Caution: this machine should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, this machine
should be observed to verify normal operation in the configuration in which it
will be used.
*MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding
EMC and needs to be installed and put into service according to the EMC
information provided in the ACCOMPANYING DOCUMENTS.
*Portable and mobile RF communications equipment can affect MEDICAL
ELECTRICAL EQUIPMENT.
* Do not use a mobile phone or other devices that emit electromagnetic fields,
near the unit. This may result in incorrect operation of the unit.
Caution: This unit has been thoroughly tested and inspected to assure proper
performance and operation!
WARNING:
The use of ACCESSORIES, transducers and cables other than those specified,
with the exception of transducers and cables sold by the MANUFACTURER of
the COMPRESSOR NEBULIZER as replacement parts for internal
components, may result in increased EMISSIONS or decreased IMMUNITY of
the ME EQUIPMENT or ME SYSTEM.
Warranty Information
33
Warranty Information
34
Warranty Information
Guidance and manufacture’s declaration – electromagnetic immunity
Immunity test
Power frequency
magnetic field IEC
61000-4-8
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
3A/m 3A/m
Floors should be wood, concrete or
ceramic tile. If floor are covered with
synthetic material, the relative humidity
should be at least 30%.
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
(50Hz/60Hz)
Electrostatic
IEC 61000-4-2
discharge (ESD)
IEC 60601 test
Compliance
level level
Electromagnetic environment - guidance
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment
specified below. The customer or the user of Digital Blood Pressure Monitor should assure
that it is used in such an environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacture’s declaration – electromagnetic immunity
Immunity test
80 MHz to 2.5
GHz
3A/m
3A/m
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Portable and mobile RF communications
equipment should be used no closer to any
part of the Digital Blood Pressure Monitor,
including cables, than the recommended
separation distance calculated from 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
and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
Radiated RF
IEC 61000-4-3
IEC 60601 test
Compliance
level level
Electromagnetic environment - guidance
Recommended separation distance
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment
specified below. The customer or the user of Digital Blood Pressure Monitor should assure
that it is used in such an environment.
35
Immunity test
80 MHz to 2.5
GHz
3A/m
3A/m
survey,a should be less than the
compliance level in each frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, 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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Digital Blood Pressure
Monitor is used exceeds the applicable RF compliance level above, the Digital Blood
Pressure Monitor should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the
Digital Blood Pressure Monitor.
Radiated RF
IEC 61000-4-3
IEC 60601 test
Compliance
level level
Electromagnetic environment - guidance
Warranty Information
36
Recommended separation distances between
portable and mobile RF communications equipment and the Digital Blood Pressure Monitor.
output power
of transmitter
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
Separation distance
(m)
according to frequency of transmitter
Pressure Monitor is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the Digital Blood Pressure
Monitor can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the Digital
Blood Pressure Monitor as recommended below, according to the maximum output power
of the communications equipment.
Warranty Information
80 MHz to 800 MHz
0.01
0.1
1
10
100
0.117 0.233
0.369 0.738
1.167 2.333
3.689 7.379
11.667 23.333
80 MHz to 800 MHz
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