Omega BSP-11 User manual

1
EC REP
Caution
Mandatory
Prohibited
Type BF Equipment
Consult Instructions For Use
Serial Number
Discard the used product to the recycling collection point
according to local regulations
The product conforms to the requirements of the EC Directive
MDD(93/42/EEC) on medical devices
0197
S N
Manufacturer
Authorized Representative in the European Community
2014.01
2
Thank you for purchasing the BSP-11 Blood Pressure Monitor.
This unit has been carefully constructed using reliable circuitry and durable materials, designed
to bring years of accurate results and satisfactory performance when used properly.
This device is intended for non-invasive measuring an adult individuals systolic, diastolic blood
pressure and heart rate using the oscillometric method. The device is not intended for use on
infants and children. The device is designed for home or clinical use. All results can be read on
one LCD display screen. Measurements are to be taken from the upper arm of the adult.
Please read this manual thoroughly before using the unit. Please retain this manual for future
reference. For specic information about your blood pressure, please consult your doctor or
health care professional.
To avoid risks and damages please follow all warning precautions. Operate the unit only as
intended. Read all instructions prior to use.
WARNING SIGNS AND SYMBOLS
Safety NoticeContents 1
Safety Notice .............................................................................................................. 02
Unit Illustration .......................................................................................................... 04
Important Testing Guidlines ................................................................................. 07
Quick Start ................................................................................................................... 08
Unit Operation ........................................................................................................... 09
Battery Operation .............................................................................. 09
Time/Date Settings ............................................................................ 10
Applying The Arm Cu ..................................................................... 11
Testing .................................................................................................... 12
Power O .............................................................................................. 14
Memory Check .................................................................................... 14
Memory Deletion ............................................................................... 15
Troubleshooting ................................................................................. 16
Blood Pressure Information ................................................................................... 18
Blood Pressure Questions & Answers ................................................................. 20
Maintenance ................................................................................................................ 21
Specications .............................................................................................................. 23
Warranty ........................................................................................................................ 25
ARM TYPE FULLY AUTOMATIC
DIGITAL BLOOD PRESSURE MONITOR
INSTRUCTION MANUAL
MODEL: BSP-11

1~2cm (0.4~0. 8 inch)
22 ~36 cm
（8 .6~14.2 i nc h)
Ma in Art e r y
LE FT A RM
INDEX
1~2cm(0.4~0.8 i nch)
22~36c m
（8.6~14.2 i nc h )
Main Arte ry
LEF T ARM
IND EX
Systolic Blood Pressure
Diastolic Blood Pressure
Pulse Rate
LCD
Arm Cuff
MEM Button
" "
" "
Button
M oni tor U nit
Air Tube
Air Plug
Air Jack
Display
A r m C uf f
3.Arm Cuff
C ontents
5.Medical AC Adapter(DC6.0 V, 600mA)
(recommended, not provided)
4.Storage Bag
2.Owner's Manual
1.Monitor Unit
Battery cover
Do not mix new and old batteries simultaneously.
Replace batteries when Low Battery Indicator appears on screen." "
Be sure battery polarity is correct.
Do not mix battery types. Long-life alkaline batteries are recommended.
Remove batteries from device when not in operation for more than 3 months.
Dispose batteries properly; observe local laws and regulations.
B a tter y P r ecaut ion s
Individuals with serious circulation problems may experience discomfort.
Consult your physician prior to use.
Contact your physician if test results regularly indicate abnormal readings.
Do not attempt to self-treat these symptoms without consulting your
physician first.
Product is designed for its intended use only. Do not misuse in any way.
Product is not intended for infants or individuals who cannot express
their intentions.
Do not disassemble or attempt to repair.
Do not use cell phones and other devices, which generate strong electrical
or electromagnetic fields, near the device, as they may cause incorrect
readings and interference or become interference source to the device.
Only use a recommended AC adapter complying with EN 60601-1 and
EN 60601-1-2（see page 6). An unauthorized adaptor may cause fire and
electric shock.
C auti on
STOP/START
AC Adapter Jack
ME M
S Y S
mmHg
DIA
mmHg
P U L S E
/min
S TOP
ST ART
ME M
S Y S
mmHg
DI A
mmHg
PULSE
/min
ST OP
ST ART
mmH g
S Y S
DI A
mmH g
PLUSE
/min
ME M
S T O P
S T A R T
Last 3 Results Average
Irregular Heartbeat Indicator
Time
Date
Systolic
Blood
Pressure
Diastolic
Blood
Pressure
Pulse Rate
Low Battery Indicator
WHO Blood Pressure
Classification Indicator
1
ARM TYPE FULLYAUTOMATIC
DIGITALBLOOD PRESSURE MONITOR
INSTRUCTION MANUAL
MODEL: BSP-11
Safety Notice Unit Illustration
Unit IllustrationUnit Illustration
3 4
5 6

1.
Sit in a calm environment for at least 5 minutes prior to testing.
3. Do not stand while testing. Sit in a relaxed position while keeping your arm level with
your heart.
4. Avoid speaking or moving body parts while testing.
5. While testing, avoid strong electromagnetic interference such as microwave ovens and
cell phones.
6. Wait 3 minutes or longer before re-testing.
7
. Test comparisons should only be made when monitor is used on the same arm, in the
same position, and at the same time of day.
9. This blood pressure monitor is not recommended for people with severe arrhythmia.
10. Do not use this blood pressure monitor if the device is damaged.
Avoid eating, exercising, and bathing for 30 minutes prior to testing.
2.
. Try to measure your blood pressure at the same time each day for consistency.
8
1. Install batteries
2. Insert cuff air plug into the left side of monitor unit. (See Figure B)
. (See Figure A )
3. Remove thick clothing from the arm area.
4. Rest for several minutes prior to testing. Sit down in a quiet place, preferably at a desk
or table, with your arm resting on a firm surface and your feet flat on the floor.
(See Figure C )
5. Apply cuff to your left arm and keep level with your heart. Bottom of cuff should be
placed approximately 1-2cm (0.4-0.8'') above elbow joint. (See Figures D&E)
1-2cm ''(0.4-0.8 )
Battery Installation
Slide battery cover off as indicated by arrow.
Install 4 new AAA alkaline batteries according to polarity.
Close battery cover.
AC adapter jack
AC adapter jack is on the right side of the monitor. Medical AC adapter(DC 6.0 V, 600mA)
can be used with the device (recommended, not provided). The adapter connect pin should
be positive inside and negative outside with a 2.1mm coaxial joint.
Do not use any other type of AC adapter as it may harm the unit.
Time/Date Setting
Figure C
Figure A Figure B
Figure D Figure E
6. Press Button to start testing."START/STOP"
With power off, press “”about 3 seconds to set the Time/Date mode.
Set month first by adjusting the “MEM”button, Press “STOP/START ”button to set the
day, hour, and minute in same way.
No matter in which setting mode, press“START/ STOP”button to turn the unit off.
All information will be saved.
Note: if unit is left on and not in use for 3 minutes, it will automatically save all
information and shut off .
START/STOP button
M
D
ST ART
ST OP
MEM
SYS
mmHg
DIA
mmHg
PULSE
/min
mmHg
S Y S
DI A
mmHg
PLUSE
/min
ME M
S T O P
S T A R T
Important Testing Guidlines Quick Start
Unit Operation Unit Operation
7 8
9 10

mmHg
M
D
Applying the Arm Cuff
1. Firmly insert air plug into opening located on left side of monitor unit.
2. With sticky nylon section facing outward, insert end of cuff underneath metal ring
of cuff
3. Fasten cuff about above the elbow joint. For best results apply cuff to
bare arm and keep level with heart while testing
.
1-2cm (0.4-0.8'')
.
Note: Do not insert air plug into opening located on right side of monitor unit.
This opening is designed for an optional power supply only.
1-2cm ''(0.4-0.8 )
Testing
1. Power On
" START/STOP " The LCD screen will
appear for one second as unit performs a quick diagnosis. Along tone indicates
device is ready for testing.
Press and hold button until a beep sounds.
Note: Unit will not function if residual air from previous testing is present in cuff.
The LCD will flash " " until pressure is stabilized.
2. Pressurization
Initial pressure is first pumped to 190 mmHg. If the current user's systolic blood pressure
is over 190mmHg, the unit will automatically re-inflate to the proper shelf.
3. Testing
After cuff inflation, air will slowly subside as indicated by the corresponding cuff
pressure value. Aflashing " " will appear simultaneously on screen signaling
heart beat detection.
mmHg
M
D
Note: Keep relaxed during testing. Avoid speaking or moving body parts.
4. Result Display
Three short beeps sound when testing is complete. The screen will display
measurements for systolic and diastolic blood pressure.
Note: Refer to Page for detail WHO Blood Pressure Classification Information18~19
Note: If the memory is less than 3 groups , press the "MEN" button to display the last group.
Power Off
turn off the power itself about 3 minutes if no operation in any mode.
The " START/ STOP" button can be pressed to turn off the unit in any mode. The unit can
5.Storing Test Results
It will automatically store by date .If the number of tests surpasses the allotted 120 memories ,
the most recent tests will appear first , thus eliminating the oldest readings.
Safety Precaution: If pressure in arm cuff becomes too extreme while testing,
press the " START/STOP " button to turn power off. The cuff pressure will rapidly
dissipate once the unit is off.
Memory Check
With power off, press and hold MEM button to turn the unit on. The LCD will display the
average test results from the last 3 readings.Press MEM button again,the LCD will display
the last measurement memory as NO: 01 reading . Older test result in memory can be viewed
by pressing the MEM button.
" "
" "
" "
M
D
N o
ST ART
ST OP
ME M
S Y S
mmHg
DI A
mmHg
PULSE
/min
Irregular Heartbeat Indicator
If the monitor detects an irregular heart rhythm two or more times during the measuring
process, the Irregular Heartbeat Symbol " "appears on screen along with
measurement results. Irregular heartbeat rhythm is defined as rhythm that is either 25%
slower or faster than the average rhythm detected while measuring systolic blood pressure
and diastolic blood pressure. Consult your physician if the Irregular Heartbeat Symbol
" " frequently appears with your test results.
Indicator
Unit Operation Unit Operation
Unit Operation Unit Operation
11 12
13 14

Low Battery Indicator
4 short warning beeps sound when battery life is depleting and unable to inflate cuff for
testing. The " " appears simultaneously for approximately 5 seconds prior to shutting
off. No memory loss will occur throughout this process.Replace batteries at this time.
" "displayed
Cuff is too tight or not
properly positioned on
the arm
Firmly reposition cuff
approximately ( )
above the elbow joint
( See Page 11)
1-2cm 1/2"
Inaccurate test results due to
body movement or monitor
movement
Sit in a relaxed position with
arm placed near heart. Avoid
speaking or moving body parts
while testing. Make sure the
monitor unit is placed in a
stationary position throughout
the testing period.
( See Page 8)
Blood pressure
results are not
within typical range
Cuff fails to inflate properly Make sure hose is properly
fastened to cuff and monitor unit
Blood Pressure
Blood pressure is the force of blood pushing against the walls of arteries. It is typically
measured in millimeters of mercury (mmHg.) Systolic blood pressure is the maximum
force exerted against blood vessel walls each time the heart beats. Diastolic blood
pressure is the force exerted on blood vessels when the heart is resting between beats.
An individual's blood pressure frequently changes throughout the course of a day.
Excitement and tension can cause blood pressure to rise, while drinking alcohol and
bathing can lower blood pressure. Certain hormones like adrenaline (which your
body releases under stress) can cause blood vessels to constrict, leading to a rise in
blood pressure.
If these measuring numbers become too high, it means the heart is working harder
than it should.
Pressurization is over
300mmHg Read user manual carefully and
re-test properly.
Improper operation Read user manual carefully and
re-test properly.
200
150
Upper curve : systolic blood pressure
Lower curve: diastolic blood pressure
Note: Memory cannot be recovered once it has been deleted.
WHO Blood Pressure Classification Indicator
The BSP-11 is equipped with a classification indicator based on established guidelines
from the World Health Organization. The chart below (color coded on monitor unit)
indicates test results.
Severe Hypertension
Mild Hypertension
High-n
Optimal
Moderate Hypertension
ormal
Normal
Troubleshooting
Problem Solution
Possible Cause
Example: fluctuation within a day (male, 35 years old)
mmHg
100
50
6 1 2 18 2 4
Time of day
Memory Deletion
While in memory check mode. Press and hold on for about 3 seconds to
delete all history results and the LCD screen display“ ” with beep sounds. Then press
button to turn off the unit.
" START/ STOP"
" START/ STOP"
: Classification IndicatorBlood Pressure
Mild Hypertension
Hypertension is a dangerous disease that can affect the quality of life. It can lead
to a lot of problems including heart failure, kidney failure, and cerebra
By maintaining a healthy lifestyle and visiting your physician on a regular basis,
hypertension and relative diseases are much easier to control when diagnosed in their
early stages.
Health Reminder
Systolic
Severe Hypertension
Moderate Hypertension
Mild Hypertension
High-normal
Normal
180
160
140
130
120
80 85 90 100 110 Diastolic
( mmHg )
( mmHg )
Optimal
Note: Do not be alarmed if an abnormal reading occurs.
each day over an
extended period of time. Consult your physician if test results remain abnormal.
A better indication of an individual's
blood pressure occurs after 2-3 readings are taken at the same time
Q: What is the difference between measuring blood pressure at home or at a professional
healthcare clinic?
A: Blood pressure readings taken at home are now seen to give a more accurate account as
they better reflect your daily life. Readings can be elevated when taken in a clinical or
medical environment. This is known as White Coat Hypertension and may be caused by
feeling anxious or nervous.
Note: Abnormal test results may be caused by:
1. Improper cuff placement
Make sure cuff is snug-not too tight or too loose.
Make sure bottom of the cuff is approximately 1-2cm (1/2'') above the elbow
joint.
2. Improper body position
Make sure to keep your body in an upright position.
3. Feeling anxious or nervous
Take 2-3 deep breaths, wait a few minutes and resume testing.
Q: What causes different readings?
A: Blood pressure varies throughout the course of a day. Many factors including diet,
stress, cuff placement, etc. may affect an individual's blood pressure.
Q: Should I apply the cuff to the left or right arm? What is the difference?
A: Either arm can be used when testing, however, when comparing results, the same arm
should be used. Testing on your left arm may provide more accurate results as it is
located closer to your heart.
Q: What is the best time of day for testing?
A: Morning time or any time you feel relaxed and stress free.
haemorrhaging
Unit Operation Unit Operation
Unit Operation Blood Pressure Information
15 16
17 18
Blood Pressure Information 19 Blood Pressure Questions & Answers 20

mmHg
mmHg
/min
S Y S
DIA
PLUSE
ME M
S T O P
S T A R T
1. Avoid dropping, slamming, or throwing the unit.
2. Avoid extreme temperatures. Do not expose unit directly under sunshine.
3. When cleaning the unit, use a soft fabric and lightly wipe with mild detergent.
Use a damp cloth to remove dirt and excess detergent.
Operating Environment
Humidity
Temperature 10℃ ℃ ℉ ℉~ 40 (50 ~104 )
15% ~90%RH
Pressure Atmospheric Pressure
Product Description
Model
Display
Measurement Method
Measurement Range
Pulse
Measurement Accuracy
Pressurization
Memory
Function
Power Source
Battery Life
Unit Weight
Unit Dimensions
Cuff Circumference
Oscillometric Method
Pressure
Pressure
Pulse
Arm-type FullyAutomatic Digital Blood Pressure Monitor
BSP-11
LCD Digital Display Size: 62.7mm×46.4mm (2.47" x 1.83")
0mmHg～300mmHg
30 to 180 Beats/Minute
±3mmHg
±5%
120 Memories
Low Battery Detection
Automatic Power-Off
4 AAA batteries or Medical AC Aadapter(DC6.0V, 600mA)
(recommended, not provided)
Approximately 2 m at 3 tests per dayonths
Approx.360g (12.7oz.) (excluding battery)
Approx.140 x 98 x 48mm (5.51"x 3.86"x 1.89")(L x W x H)
Approx.135 (W)×485(L) mm
(Medium cuff: Fits arm circumference 22-36 cm)
Automatic Pressurization
mmHg
mmHg
/min
S Y S
DIA
PLUSE
MEM
S T O P
S T A R T
mmHg
mmHg
/min
S Y S
DIA
PLUSE
ME M
S T O P
S T A R T
mmHg
mmHg
/min
S Y S
DIA
PLUSE
ME M
S T O P
S T A R T
4. Do not soak cuff in water!
5.
Cuff Cleaning: Apply a small amount of rubbing alcohol to
a soft cloth to clean cuff's surface. Use a damp cloth (water-based) to wipe clean.
Allow cuff to dry naturally at room temperature.
Do not use petrol, thinners or similar solvents.
6. Remove batteries when not in operation for an extended period of time.
7. Do not disassemble product.
8. It is recommended the performance should be checked every 2 years.
9. Expected service life: Approximately three years at 10 tests per day.
This Blood Pressure Monitor complies with the European regulations .This blood
pressure monitor also complies with mainly following standards
(included but not limited):
Safety standard:
EN 60601-1 Medical electrical equipment part 1: General requirements for safety
EMC standard:
EN 60601-1-2 Medical electrical equipment part 1-2: General requirements for
safety- Collateral standard: Electromagnetic compatibility- Requirements and tests
Performance standards:
EN 1060-1 Non-invasive sphygmomanometers - General requirements
EN 1060-3 Non-invasive sphygmomanometers - Supplementary requirements for
electromechanical blood pressure measuring systems.
EN 1060-4 Non-invasive sphygmomanometers - Test procedures to determine the overall
system accuracy of automated non-invasive sphygmomanometers.
C or r ect D isposal o f T hi s P r oduct
(Waste Electrical & Electronic Equipment)
This marking shown on the product indicates that it should not be disposed with other
household waste at the end of its life. To prevent potential harm to the environment or to
human health, please separate this product from other types of wastes and recycle it
responsibly. When disposing this type of product, contact the retailer where product was
purchased or contact your local government office for details regarding how this item can
be disposed in an environmentally safe recycling center.
Business users should contact their supplier and check the terms and conditions of the
purchasing agreement. This product should not be mixed with other commercial wastes
for disposal. This product is free of hazardous materials.
Storage Environment
Humidity
Classification:
Temperature: -20 ~55 (-4 ~131 )℃ ℃ ℉ ℉
15% ~90%RH
Internal Powered Equipment,Type BF ,Cuff is theApplied Part
Specifications are subject to change without notice.
IP 22
Ingress Protection Rating:
Maintenance Maintenance
Specications Specications
21 22
23 24

The Blood Pressure Monitor is guaranteed from the date of purchase. If theBlood Pressure
Monitor does not function properly due to defective components or poor workmanship,
we will repair or replace it freely. The warranty does not cover damages to your Blood
Pressue Monitor due to improper handling. Please contact local retailer for details.
Warranty 25
Distributed by: Omega Medical Instruments Pty Ltd
Suite 1D, Lvl 23 Governor Phillip Tower, 1 Farrer Pl NSW 2000 Australia
Customer Care Line: 1300 883 257