SantaMedical BW-210 User manual

Wrist Type Blood Pressure Monitor
Model No.: BW-210
INSTRUCTION MANUAL
PLEASE READ THIS INSTRUCTION MANUAL COMPLETELY
BEFORE OPERATING THIS UNIT.

Index
1
2
3
4
5
6
7
8
10
11
13
14
15
15
16
17
1.
Important Information Before Use
Introduction
2.
3.
4. Description of LCD Display
5.
6. Setting the Date and Time
7. Applying Your Cuff
8. Measurement of Pulse Rate and Blood Pressure
9. World Health Organization (WHO)
10.Memory Function
11.Troubleshooting
12.Error Codes
13.Care and Maintenance
14.Applied Standards
15.Technical Specification
16.EMC Tables
Blood Pressure Monitor Features
Battery Installation

1
To achieve the maximum benefit from your blood pressure monitor, we recommend
that you first consult with your physician or trained health care professional.
Thank you for purchasing an Blood Pressure Monitor. With proper care and use,
your monitor will provide you with many years of reliable readings.
The method of measurement that your Automatic Monitor uses is called the
oscillometric method. The monitor detects your blood’s movement through the
artery in your wrist and converts the movements into a digital reading. The
oscillometric method does not require a stethoscope, making the monitor easy-to-
use. The preformed cuff requires little effort to apply and is comfortable to wear.
Clinical research has proven a direct relationship between blood pressure in the
wrist and blood pressure in the arm. Because the arteries in the wrist and arm are
connected, changes in wrist blood pressure reflect changes in arm blood pressure.
Frequent wrist blood pressure measurements will provide you and your physician
with an accurate indication of change in your true blood pressure.
People with severe hypertension, severe arteriosclerosis, or severe diabetes,
should consult their physician about monitoring blood pressure at the arm.
Blood pressure readings determined with this device are equivalent to
measurements obtained by a trained observer using the cuff/stethoscope
auscultation method, within the limits prescribed by the National Standard for
Electronic or Automated Sphygmomanometers.
Introduction

2
1. Blood pressure measurements should only be interpreted by a physician or a trained
health care professional who is familiar with your medical history. Through regular use of
this device and recording of your measurements, you can keep your physician informed
of the changes in your blood pressure.
2. Perform your measurement in a quiet place. You should be seated in a relaxed position.
3. Avoid smoking, eating, taking medication, alcohol consumption or physical activity 30
minutes prior to taking a reading. If you are exhibiting signs of stress, avoid taking your
measurement until the feeling subsides.
4. Rest 15 minutes prior to taking a reading.
5. Remove any constrictive clothing or jewelry that may interfere with the cuff placement.
6. Keep the monitor stable during measurement to achieve an accurate reading. Remain
still; do not talk during the measurement.
7. Record your daily blood pressure and pulse readings on a chart.
8. Take your readings at the same time, each day or as recommended by your physician to
get an accurate indication of change in your true blood pressure.
9. Wait a minimum of 15 minutes between readings to allow for the blood vessels to return
to normal. The wait time may vary depending on your individual physiological
characteristics.
10. Although such cases are rare, for those with an extremely weak pulse or irregular
pulse, errors may result which prevent proper measurement. If abnormal variations are
noticed, consult with your physician or trained healthcare professional.
11. This device is intended for adult use. While taking a measurement, you can stop the
inflation or deflation process of the cuff at any time by pressing the POWER button.
Important Information Before Use

3
Blood Pressure Monitor Features
Storage Case
START/POWER
Button (on/off)
MEMORY Recall
Button
LCD Display
Wrist Cuff
Date and Time
Button

4
Description of LCD Display
Date Time
Systolic Pressure
Diastolic Pressure
Pulse Rate
Heartbeat Symbol
Inflation/Deflation Symbol
Low Battery Symbol
Average Measurement Symbol
Memory Symbol
Memory Sets
4

5
Low battery warning:
It is necessary to replace the batteries when the Low Battery symbol “ ”
appears on the display, or when the display does not turn on after the
POWER button is pressed.
Battery Installation
Replacing the Battery:
1. Press down on latch and lift the cover on the
bottom of the monitor.
2. Insert or replace 2 x 1.5 V AAA batteries into the
battery compartment, ensuring to match the
indicated polarity symbols. Always use new
batteries.
3. Replace the battery cover.
NOTE: Battery-operated
1. Please properly dispose of the batteries away from small children and heat.
2. It is recommended to remove the batteries if the unit will not be used for an extended
period of time.
3. For long durations of non-operation, please remove all batteries from the device.
4. Batteries must be disposed of in accordance with local environmental and institutional
policies.
5. Dispose of used batteries in accordance with the applicable legal regulations. Never
dispose of batteries in the normal household waste.

Setting the Date and Time
It is necessary to set the date and time for the unit every time batteries are
initially installed or replaced.
1. When the unit is off (a blank display screen) or after replacing batteries, press
and release the “Date and Time” button; the “Year” will begin to flash on the
display.
2. Press the “MEMORY” button to advance the display to the desired “Year”, press
“POWER” button to confirm the “Year”.
3. Next, the “Month” will blink. Repeat steps 1 and 2 to set the “Month” and “Date”,
then “hour”, then “Minute”.
Year
Press the
“Date and Time”
button
Month
Press the
“POWER”
button
Date
Press the
“POWER”
button
Hour
Press the
“POWER”
button
Minute
Press the
“POWER”
button
Press the
“POWER”
button
4. After setting the
minute, the unit will
automatically exit
out of the date/time
setting mode and
briefly show the
word OFF before
shutting down.
6

7
It is important to avoid smoking, eating, taking medication, alcohol
consumption or physical activity 30 minutes prior to taking a reading. If
for any reason you are unable to or should not use your left wrist,
please modify the instructions for cuff application to your right wrist.
Your physician can help you identify which wrist is best for you to take
measurements from.
Applying Your Cuff
1. Remove any constrictive clothing or jewelry that may interfere with
cuff placement.
2. Be seated at a table or desk with your feet flat on the floor.
3. Hold your wrist in front of you with your palm facing upward.
4. Apply the preformed cuff to your wrist so that the digital display
face is positioned on the inside area of your wrist facing you.
5. Adjust the cuff 0.5~1 cm from the edge of the head of the ulna
bone.
6. The cuff should fit comfortably, yet snugly
around your wrist.
Blood pressure naturally varies from one wrist to the
other; therefore, measure your blood pressure on the
same wrist to ensure comparability of the two readings.
0.5~1 cm

8
Measurement of Pulse Rate and Blood Pressure
Please read the preceding portions of this manual prior to taking your first reading.
1. Rest your elbow on a solid surface with your palm facing upward. Elevate your
wrist so that the cuff is at the same level as your heart. Relax your left hand.
2. Press the POWER button. This will turn the power on.
3. After the self-test, the values for the last reading will appear
on the display.
4. The blood pressure monitor start to measure.
5. The cuff will automatically begin to inflate, with the display showing the
increasing pressure in the cuff. As the pressure increases, an arrow
pointing up will appear on the display.
6. When the inflation has reached optimum level, the display will begin to
show the decreasing pressure; the screen will display an arrow
pointing down while you feel the pressure of the cuff decrease.

9
Measurement of Pulse Rate and Blood Pressure
7. To detect the heartbeat, the heartbeat symbol will appear and
continuous flashes on the LCD display.
8. Your blood pressure measurement and pulse will display
simultaneously on the screen.
9. The Hypertension Indicator will indicate your reading range on the
display separately.
10.The reading will automatically be stored in memory.
11. Select POWER to turn the unit off and conserve energy and battery life. The unit
will automatically shut-off approximately 2 minutes.

10
The World Health Organization has established globally accepted standards for the
assessment of high or low blood pressure readings. The below chart should be
considered only as a guideline, always consult with your physician or health care
professional to interpret your individual results.
World Health Organization (WHO)
Diastolic Blood Pressure
85
90
100
110
80
130120
Optimal
Normal
High-Normal
Mild Hypertension (Grade 1)
Moderate Hypertension
(Grade 2)
140 160
Severe Hypertension
(Grade 3)
180
Systolic Blood Pressure
Hypertension Indicator

11
Memory Function
Press the
“MEMORY”
button
You can recall up to 60 total measurements in memory, plus an average of the last 3
stored measurements in memory to share with your physician or trained healthcare
professional.
Recalling Measurements in Memory:
1. Press and release the “MEMORY” button. The unit will first display the average of
the last 3 stored measurements.
3. All results for a given measurement will display, including measurement results,
pulse rate, Hypertension Indicator, and date/time stamp.
4. When the number of readings exceeds 60, the oldest data will be replaced with
the new record.
5. Press the Power button to turn the monitor OFF at any time during review of the
stored measurements.
2. Continue to press the “MEMORY” button to
successively view the next previously stored
measurements. Measurements will appear on
the display from most current to oldest; the
memory number will appear on the lower left
corner.

12
Memory Function
From power display off, press and hold down the “MEMORY” button until
the display shows CLr. This indicates that all measurements have been
erased.
Clearing Measurements from Memory:

Troubleshooting
Nothing appears in the
display even when the
power is turned on.
Problem
Low Battery Symbol
appears.
Batteries are drained.
Probable Cause
Batteries are drained.
In colder temperatures batteries have weaker
electrical charges.
Replace all batteries with new ones.
Recommended Action
Replace all batteries with new ones.
Warm up the batteries, or use the device in a
warmer setting.
Device operation time is
inconsistent.
No reading after
measurement.
Suspicious blood
pressure results.
Different battery brands have different life spans.
Batteries are drained.
Perhaps the cuff was improperly positioned.
Blood pressure naturally varies throughout the day.
Use Alkaline batteries and replace all
batteries at the same time with same brand
batteries.
Replace all batteries with new ones.
Adjust patient and wrist cuff to measure.
Rest a while, relax and measure again.
Suspicious heart rate
results.
Bodily movement during device use.
Measurement shortly after exercise or exposure to
the outdoors.
Refrain from moving during measurement.
Do not take measurements after exercise or
coming back from the outdoors.
Battery are not correctly aligned with terminals. Reinsert batteries in the correct position.
Power switches off
automatically.
During measuring, air re-
inflates.
System design.
It could be a normal action if the user's blood
pressure is higher than the initial pressure value,
the device automatically pumps to a higher
pressure by 40mmHg each time.
Push the power button again, and then begin
measure again.
Relax, and try to take a measure again.
The wrist cuff is not fastened properly. Check that the wrist cuff is fastened properly
and retake the measurement.
13

14
Error Codes
Err Meaning Corrective Action
Err 0 No pulse or detect pulses not enough. Take off heavy clothes and retry again.
Err 1 Leakage in Cuff Pressure/Inflation too low. The wrist cuff is not fastened properly. Re-
apply the cuff, and take a measurement again.
Err 2 Pressure fault. Rest a while, relax and retry again.
Err 3 Deflation fault. The wrist cuff is not fastened properly. Re-
apply the cuff, and take a measurement again.
Err Memory error. Take off batteries to reboot the device, then
take another measurement.
Low batteries. Replace all batteries with new ones.

Care and Maintenance
1. Clean the device and wrist cuff carefully only with a slightly moistened cloth.
2. Do not immerse the device in water. It may cause damage if water enters.
3. Do not use any gas, strong detergent, or solvents to clean the device, including the wrist cuff.
4. Disconnect the cuff and tubing from the monitor prior to storing.
5. Do not use any liquids on the monitor or cuff.
6. Use a soft, dry cloth to clean your monitor.
7. Do not store in direct sunlight, dust or excessive humidity.
8. Avoid extreme temperatures.
9. Do not disassemble the monitor or cuff.
10.Remove batteries if the monitor will not be used for an extensive period of time.
This product conforms to the provisions of the EC directive MDD (93/42/EEC). The following standards apply to design
and/or manufacture of the products:
‧EN 1060-1
Non-invasive sphygmomanometers-Part1 : General requirements
‧EN 1060-3
Non-invasive sphygmomanometers-Part 3 : Supplementary requirements for electro-Mechanical blood pressure
measuring system
‧EN 1060-4
Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers
‧ANSI/AAMI Sp10
Electronic or automated sphygmomanometers
．ISO 14971
Medical devices-Application of risk management to medical devices. The Classification according to IEC/EN 60601-1
sub-claues 5:
．Internally powered equipment
．IPX0
．Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous
oxide
．Continuous operation
Applied Standards
15

16
Technical Specification
10℃
40℃
-20℃
50℃
• Measuring range :
• Calibration Accuracy:
• Operating environment :
o o o o
10 C~40 C (50 F~104 F)
with relative humidity up to 85% (non condensing)
• Storage/ Transportation environment :
o o o o
-20 C~+50 C (-4 F~+122 F)
with relative humidity up to 85% (non condensing)
• Power Source :
• Weight :
• Dimensions :
• Cuff circumference (M Size) : approx. 12.5~21 cm
2 x 1.5 V AAA batteries
approx. 109g (exclude batteries)
approx. 64mmX74mmX31mm (WXHXD)
Blood Pressure : 30~280 mmHg
Pulse Rate : 40~199 beats/min
Blood Pressure : ± 3 mmHg
Pulse rate : ± 4% of reading

The BW-210 Wrist Type Blood Pressure Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the BW-210 Wrist Type Blood Pressure
Monitor should assure that it is used in such an environment.
Guidance and manufacturer's declaration-electromagnetic emissions
Emissions test Compliance Electromagnetic environment guidance
RF emissions
CISPR 11
Group 1 The BW-210 Wrist Type Blood Pressure Monitor 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.
RF emissions
CISPR 11
Class B
The BW-210 Wrist Type Blood Pressure Monitor is
suitable for use in all establishments, including domestic
establishments and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Not
applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not
applicable
17
EMC Tables

The BW-210 Wrist Type Blood Pressure Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the BW-210 Wrist Type Blood Pressure
Monitor should assure that it is used in such an environment.
Guidance and manufacturer's declaration-electromagnetic immunity
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic
environment-guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
± 6 kV
contact
± 8 kV air
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative
humidity should be at least 30 %.
± 6 kV
contact
± 8 kV air
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
3 A/m
18
EMC Tables