Index
Important Information
Contents and Display Indicators
Intended Use
Contraindication
Product Description
Specifications
Notice
Setup and Operating Procedures
Battery Loading
Clock and Date Adjustment
Connecting the Cuff to the Monitor
Applying the Cuff
Body Posture During Measurement
Taking Your Blood Pressure Reading
Displaying Stored Results
Deleting Measurements from the Memory
Assessing High Blood Pressure for Adults
Troubleshooting (1)
Troubleshooting (2)
Maintenance
Explanation of Symbols on Unit
Electromagnetic Compatibility Information
2
3
4
4
5
6
8
12
12
13
14
15
16
17
19
21
22
23
24
25
26
28
Important Information
Normal Blood Pressure Fluctuation
All physical activity, excitement, stress, eating, drinking, smoking, body
posture and many other activities or factors (including taking a blood
pressure measurement) will influence blood pressure value. Because of
this, it is unusual to obtain identical multiple blood pressure readings.
Blood pressure fluctuates continually ----- day and night. The highest value
usually appears in the daytime and lowest one usually at midnight.
Typically, the value begins to increase at around 3:00AM, and reaches to
highest level in the daytime while most people are awake and active.
Considering the above information, it is recommended that you measure
your blood pressure at approximately the same time each day.
Too many measurements may cause injury due to blood flow interference,
please always relax a minimum of 1 to 1.5 minutes between measurements
to allow the blood circulation in your arm to recover. It is rare to obtain
identical blood pressure readings each time.
Contents and Display Indicators
Cuff tube plug
Blood Pressure level
classification indicator
START button
MEM button
LCD display
Ready to inflate indicator
Blood Pressure Level
Classification Indicator
Irregular Hearbeat
Symbol
Memory Indicator
Date/Time Display(Alternating)
Low Battery Indicator
Systolic Pressure
Diastolic Pressure/Pulse
Rate Display(Alternating)
Intended Use
Contraindication
This Fully Automatic Electronic Sphygmomanometer is for use by medical
professionals or at home and is a non-invasive blood pressure
measurement system intended to measure the diastolic and systolic blood
pressures and pulse rate of an adult individual by using a non-invasive
technique in which an inflatable cuff is wrapped around the upper arm. The
cuff circumference is limited to 22cm-48cm (approx. 8 21/32″~18 29/32″).
It is inappropriate for people with serious arrhythmia to use this
Electronic Sphygmomanometer.
- 5 -
Product Description
- 6 -
Specifications
1. Product name: Blood Pressure Monitor
2. Model: BPM5TL
3. Classification: Internally powered, Type BF Applied Part, IPX0, No AP or
APG, Continuous Operation
4. Machine size: Approx. 138mm × 98mm × 48mm (5 7/16″x 3 27/32″x 1 7/8″)
5. Cuff circumference: 22cm-30cm (8 21/32″-11 13/16″), 30cm-42cm (11
13/16″-16 17/32″) (Optional), 42cm-48cm (16 17/32″-18 29/32″) (Optional)
6. Weight: Approx. 211g (7 7/16 oz.) (exclude batteries and cuff)
7. Measuring method: Oscillometric method, automatic inflation and
measurement
8. Memory volume: 2 x 60 with time and date stamp
9. Power source: batteries: 4 × 1.5V SIZE AA
10. Measurement range:
Cuff pressure: 0-300 mmHg
Systolic: 60-260 mmHg
Diastolic: 40-199 mmHg
Pulse rate: 40-180 beats/minute
- 7 -
Specifications
11. Accuracy:
Pressure: ±3 mmHg
Pulse rate: ±5%
12. Environmental temperature for operation: 10ºC
～
40ºC(50ºF
～
104ºF)
13. Environmental humidity for operation: ≤90%RH
14. Environmental temperature for storage and transport: -20ºC
～
55C(-4ºF
～
131ºF)
15. Environmental humidity for storage and transport: ≤90%RH
16. Environmental pressure: 80KPa-105KPa
17. Battery life: Approx 500 measurements
Note: These specifications are subject to change without notice.
1. Read all of the information in the operation guide and any other literature
in the box before operating the unit.
2. Stay still, calm and rest for 5 minutes before blood pressure
measurement.
3. The cuff should be placed at the same level as your heart.
4. During measurement, neither speak nor move your body and arm.
5. Measure on same arm for each measurement.
6. Please always relax at least 1 to 1.5 minutes between measurements to
allow the blood circulation in your arm to recover. Prolonged over-inflation
(cuff pressure exceeds 300 mmHg ) of the bladder may cause bruising or
swelling of your arm.
7. Consult your physician if you have any doubt about the following :
1) The application of the cuff over a wound or inflammation.
2) The application of the cuff on any limb where intravascular access or
therapy, or an arterio-venous (A-V) shunt, is present.
3) The application of the cuff over the arm on the side of a mastectomy.
4) Simultaneously used with other monitoring medical equipment on the
same limb.
5) If you suffer with poor circulation.
- 8 -
Notice
8. This Electronic Sphygmomanometer is designed for adults and should
never be used on infants or young children. Consult your physician or other
health care professionals before use on older children.
9. Do not use this unit in a moving vehicle. This may result in erroneous
measurement.
10. Blood pressure measurements determined by this monitor are
equivalent to those obtained by a trained observer using the
cuff/stethoscope auscultation method, within the limits prescribed by the
American National Standard Institute, Electronic or automated
sphygmomanometers.
11. For information regarding potential electromagnetic or other
interference between the blood pressure monitor and other devices
together with advice regarding avoidance of such interference, please see
part ELECTROMAGNETIC COMPATIBILITY INFORMATION.
12. If Irregular Heartbeat (IHB) brought by common arrhythmias is detected
during a measurement, the will be displayed. Please ignore the results
and try again after a few minutes.
- 9 -
Notice
Note: This monitor is designed to detect Premature Ventricular
Contractions, also known as a Premature Ventricular Complex (or
complexes), Ventricular Premature Contractions (or complex or
complexes), Ventricular Premature Beats, or Extrasystoles. It is not
designed to detect Atrial Fibrillation or Atrial Premature
Beats.
13. Please only use the cuff supplied.
14. This monitor might not meet its performance specifications or cause a
safety hazard if stored or used outside the specified temperature and
humidity ranges in the specifications section.
15. To avoid cross contamination, do not share this cuff with anyone
suffering with a contagious illness.
- 10 -
Notice
16. This blood pressure monitor is verified by auscultatory method. It is
recommended
that
you
check
annex
B
of ANSI/AAMI
SP-10:2002+A1:2003+A2: 2006 for details of verification method if you
need.
- 11 -
Notice
- 13 -
2. Clock and Date Adjustment
b. While the monitor is in Clock Mode, pressing both the “START” and “MEM”
button simultaneously, a beep is heard and the month will blink at first. See
picture 2-2. Press the button “START” repeatedly, the day, hour and minute
will blink in turn. While the number is blinking, press the button “MEM” to
increase the number. Pressing and hold the "MEM" button will advance the
number quickly.
c. You can turn off the monitor by pressing the “START” button, when the
minute is blinking the time and date is confirmed.
a. Once you install the battery or turn off the monitor, it will enter Clock
Mode, and LCD will display time and date (alternating). See picture 2&2-1.
picture 2
picture 2-1
picture 2-2
d. The monitor will turn off automatically after 1 minute of no operation, with
the time and date unchanged.
e. Once you change the batteries, you should adjust the time and date.
Insert the cuff tubing connector into the socket in the left side of the monitor.
Make certain that the connector is completely inserted to avoid air leakage
during blood pressure measurements.
Avoid compression or restriction of the connection tubing during
measurement
，
which may cause inflation error, or harmful injury due to
continuous cuff pressure.
3. Connecting the Cuff to the Monitor
- 14 -
4. Applying the Cuff
1-2 cm
- 15 -
Note:
1. Please refer to the cuff circumference range in “SPECIFICATIONS” to
make sure that the appropriate cuff is used.
2. Measure on same arm each time.
3. Do not move your arm, body, or the monitor and do not move the rubber
tube during measurement.
4. Stay quiet, calm for 5 minutes before blood pressure measurement.
a. Pulling the cuff end through the medal loop (the cuff
is packaged like this already), turn it outward (away
from your body) and tighten it and close the Velcro
fastener.
b. Place the cuff around a bare arm 1-2cm above the
elbow joint.
c. While seated, place palm upside in front of you on a
flat surface such as a desk or table. Position the air tube
in the middle of your arm in line with your middle finger.
d. The cuff should fit comfortably, yet snugly around
your arm. You should be able to insert one finger
between your arm and the cuff.
5. Body Posture During Measurement
Seated
a. Be seated with your feet flat on the floor, and don’t
cross your legs.
b. Place palm upside in front of you on a flat surface
such as a desk or table.
c. The middle of the cuff should be at the level of the right atrium of the heart.
Lying Down
a. Lie on your back.
b. Place your arm straight along your side with your
palm upside.
c. The cuff should be placed at the same level as your
heart.
- 16 -
5. Please keep the cuff clean. If the cuff becomes dirty, remove it from the
monitor and clean it by hand in a mild detergent, then rinse it thoroughly in
cold water. Never dry the cuff in clothes dryer or iron it.
a. After applying the cuff and ensuring your body is in a comfortable
position, press the “START” button. A beep is heard and all display
characters are shown for self-test. See picture 6. Please contact your
retailer if any segments are missing.
b. The current memory bank (U1 or U2) will blink. See picture 6-1. Press
“MEM” button to change over to other bank. See picture 6-2. Confirm your
selection by pressing “START” button. The current bank can also be
confirmed automatically after 5 seconds with no operation.
c. After selecting the memory bank, the monitor starts to seek zero
pressure. See picture 6-3.
6. Taking Your Blood Pressure Reading
- 17 -
picture 6
picture 6-1
picture 6-2
d. The monitor inflates the cuff until sufficient pressure has built up for a
measurement. Then the monitor slowly releases air from the cuff and
carries out the measurement. Finally the blood pressure and pulse rate will
be calculated and displayed on the LCD screen separately. Irregular
heartbeat symbol (if any) will blink. See picture 6-4&6-5. The result will be
automatically stored in the current memory bank.
e. After measurement, the monitor will turn off automatically after 1 minute
of no operation. Alternatively, you can press the “START” button to turn off
the monitor manually.
f. During measurement, you can press the “START” button to turn off the
monitor manually.
Note: Please consult a health care professional for interpretation of
pressure measurements.
- 18 -
picture 6-3
picture 6-4
picture 6-5
a. After the measurement, you can review the measurements in the current
memory bank by pressing button “MEM”. The LCD will display the number
of the results in the current bank. See picture 7.
b. Alternatively, press “MEM” button in Clock Mode to display the stored
results. The current memory bank will blink and the amount of results in this
bank will be displayed. See picture 7-1. Press “START” button to change
over to other bank. See picture 7-2. Confirm your selection by pressing
“MEM” button. The current bank can also be confirmed automatically after 5
seconds with no operation.
c. After selecting the memory bank, the LCD will display the average value
of the last three results in this bank, See picture 7-3 & 7-4. If no result
stored, LCD will show dashes as picture 7-5.
- 19 -
7. Displaying Stored Results
picture 7
picture 7-1
picture 7-2
d. When the average is displayed, press the “MEM” button, the most recent
result will be shown. See picture 7-6. Followed by, the blood pressure and
pulse rate will be shown separately. Irregular heartbeat symbol (if any) will
blink. See picture 7-7&7-8. Press “MEM” button again to review the next
result. See picture 7-9. In this way, repeatedly pressing the “MEM” button
displays the respective results measured previously.
- 20 -
picture 7-3
picture 7-4
picture 7-6
picture 7-7
picture 7-5
While any result (except average reading of the last
three results) is displayed, press the “MEM” button
for three seconds, all results in the current memory
bank will be deleted after three beeps.The LCD will
show picture 8. Press the button “MEM” or “START”
to turn the monitor off.
e. When displaying the stored results, the monitor will turn off automatically
after 1 minute of no operation. You can also press the button “START” to
turn off the monitor manually.
- 21 -
8. Deleting Measurements from the Memory
picture 7-8
picture 7-9
picture 8
- 22 -
The following guidelines for assessing high blood pressure (without regard
to age or gender) have been established by the World Health Organization
(WHO). Please note that other factors (e.g. diabetes, obesity, smoking,
etc.) need to be taken into consideration. Consult with your physician for
accurate assessment, and never change your treatment by yourself.
9. Assessing High Blood Pressure for Adults
WHO/ISH Definitions and Classification of Blood Pressure Levels
- 23 -
Problem Possible Cause
Solution
LCD Display shows
abnormal result
The cuff position was not
correct or it was not properly
tightened
Apply the cuff correctly and
try again
Speaking, arm or body
movement, angry, excited or
nervous during testing
Irregular heartbeat
(arrhythmia)
Troubleshooting (1)
Body posture was not correct
during testing
Review the
“
BODY POSTURE
DURING MEASUREMENT
”
sections of the instructions and
re-test.
Re-test when calm and without
speaking or moving during the
test
It is inappropriate for people with
serious arrhythmia to use this
Electronic Sphygmomanometer.
- 24 -
Troubleshooting (2)
Problem Possible Cause
Solution
LCD shows low
battery symbol
LCD shows
“
Er 0
”
LCD shows
“
Er 1
”
LCD shows
“
Er 2
”
LCD shows
“
Er 3
”
Low Battery
Measure again after five
minutes. If the monitor is
still abnormal, please
contact the local distributor
or the factory.
Pressure system is unstable
before measurement
Fail to detect systolic pressure
Fail to detect diastolic pressure
Pneumatic system blocked or
cuff is too tight during inflation
No response when you
press button or load
battery.
Pneumatic system leakage or
cuff is too loose during inflation
Incorrect operation or strong
electromagnetic interference.
Take out batteries for five
minutes, and then reinstall
all batteries.
Apply the cuff correctly and
try again
Change the batteries
Don’t move and try again.
LCD shows
“
Er 4
”
LCD shows
“
Er 5
”
Cuff pressure above 300mmHg
LCD shows
“
Er 6
”
More than 3 minutes with cuff
pressure above 15 mmHg
LCD shows
“
Er 7
”
EEPROM accessing error
LCD shows
“
Er 8
”
Device parameter checking error
LCD shows
“
Er A
”
Pressure sensor parameter error
1. Do not drop this monitor or subject it to strong impact.
2. Avoid high temperature and direct sunlight. Do not immerse in water
as this will result in damage to the monitor.
3. If this monitor is stored in cold temperatures, allow it to acclimate to room
temperature before use.
4. Do not attempt to disassemble this monitor.
5. If you do not use the monitor for a long time, please remove the
batteries.
6. Clean the monitor with a dry, soft cloth or a soft cloth squeezed well after
moistened with water, diluted disinfectant alcohol, or diluted detergent.
7. This blood pressure monitor is calibrated at the time of manufacture. If
the blood pressure monitor is used according to the instructions, periodic
recalibration is not required. If at any time you question the accuracy of the
measurement, please contact the retailer immediately.
8. The monitor can maintain the safety and performance characteristics for
a minimum of 10,000 measurements or three years, the cuff can maintain
the performance characteristics for a minimum of 1000 measurements.
- 25 -
Maintenance
9. It is recommended the cuff should be disinfected twice a week if needed
(for example, in a hospital or in a clinic). Wipe the inner side of the cuff with
a soft cloth moistened with Ethyl Alcohol (75-90%), then dry the cuff by
airing.
Explanation of Symbols on Unit
- 26 -
Symbol for ” THE OPERATION GUIDE MUST BE READ”
Symbol for “TYPE BF APPLIED PARTS” (The cuff is type BF applied part)
Symbol for “COMPILES WITH MDD93/42/EEC REQUIREMENTS”
Symbol for “ENVIRONMENT PROTECTION – Waste electrical products should not be
disposed of with household waste. Please recycle where facilities exist. Check with
your local Authority or retailer for recycling advice”.
Symbol for “MANUFACTURER”
Symbol for “WARNING”
- 27 -
Symbol for “EUROPEAN REPRESENTATIVE”
Symbol for “DATE OF MANUFACTURE”
SN
Symbol for “SERIAL NUMBER”
Symbol for “KEEP DRY”
- 28 -
Electromagnetic Compatibility Information
Table 1
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacture’s declaration - electromagnetic emissions
The [BPM5TL] is intended for use in the electromagnetic environment specified below.
The customer or the user of the [BPM5TL] should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The [BPM5TL] 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
Harmonic
emissions:
IEC 61000-3-2
Not applicable
Voltage
fluctuations/
flicker emissions:
IEC 61000-3-3
Not applicable
The [BPM5TL] 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.
- 29 -
Table 2
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration - electromagnetic immunity
The [BPM5TL] is intended for use in the electromagnetic environment specified below.
The customer or the user of the [BPM5TL] should assure that it is used in such an environment.
IMMUNITY
test
IEC 60601test
level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic
discharge
(ESD)
IEC
61000-4-2
± 6 kV contact
± 8 kV air
± 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 %.
Power
frequency
(50/60 Hz)
magnetic field
IEC
61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
- 30 -
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration - electromagnetic immunity
The [
BPM5TL] is intended for use in the electromagnetic environment specified below.
The customer or the user of the [
BPM5TL] should assure that it is used in such an environment.
IMMUNITY
test
IEC 60601test
level
Compliance
level
Electromagnetic environment - guidance
Radiated RF
IEC
61000-4-3
3 V/m 80 MHz
to 2.5 GHz
3 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the [
BPM5TL], including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
：
80 MHz to 800 MHz
P
d
1.2
=
d
800 MHz to 2,5 GHz
P
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).
Table 3
To be continued
- 31 -
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.
a 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 [
BPM5TL] is used
exceeds the applicable RF compliance level above, the [
BPM5TL] should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the [
BPM5TL].
IMMUNITY
test
IEC 60601test
level
Compliance
level
Electromagnetic environment - guidance
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
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:
Table 3
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
continued
- 32 -
Table 4
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances between
portable and mobile RF communications equipment and the [BPM5TL]
The [
BPM5TL] is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the [
BPM5TL] can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the [
BPM5TL] as recommended
below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
m
Rated maximum
output
power of transmitter
W
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
0,01
0.12
0.12
0.23
0,1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be determined 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.
P
1.2
d
=
P
1.2
d
=
P
2.3
d
=
When LCD shows battery symbol , replace all batteries with new ones.
Rechargeable batteries are not suitable for this monitor.
Remove the batteries if the monitor will not be used for a month or more to
avoid battery leakage.
Avoid getting battery fluid in your eyes. If it should get in your eyes,
immediately rinse with plenty of clean water and contact a physician.
The monitor, the batteries and the cuff, must be disposed of
according to local regulations at the end of their usage.
1. Battery Loading
a. Open battery cover at the back of the monitor.
b. Load four “AA” size batteries. Please pay attention to polarity.
c. Close the battery cover.
- 12 -
Setup and Operating Procedures
设计
审核
批准
原稿文件编号 ＫＩＮＥＴＩＫ ＢＰＭ５ＴＬ
版 本 Ｖ３．０
尺 寸 ９５．０×７０．０
材 质 ６０ｇ双胶纸
公 差 ±１．０ｍｍ
表面处理 无
ＫＩＮＥＴＩＫ ＢＰＭ５ＴＬ Ｖ２．０
ＢＰＭ５ＴＬ Ｖ２．
Fully Automatic
Blood Pressure
Monitor
User Manual
Harvard Medical Devices Ltd.
Unit 1301, 13th Floor, Railway Plaza,
39 Chatham Road South, Tsimshatsui,
Kowloon, Hong Kong.
Kinetik Medical Devices Ltd.
Mill Road, Rugby, Warwickshire,
United Kingdom, CV21 1PR.
,
KINETIK BPM5TL UK IB 20130910
BPM5TL Series
Cuff
Rubber tube
Based on Oscillometric methodology and a silicon integrated pressure
sensor, blood pressure and pulse rate can be measured automatically and
non-invasively. The LCD display will show blood pressure and pulse rate.
The most recent 60 measurements for two users can be stored in the
memory with date and time stamp. The monitor can also show the average
reading of the last three measurements. This Electronic
Sphygmomanometer corresponds to the following standards: IEC
60601-1:2005/EN 60601-1:2006/AC:2010 (Medical electrical equipment --
Part 1: General requirements for basic safety and essential performance),
IEC60601-1-2: 2007/EN 60601-1-2:2007 /AC:2010 (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 + A1: 2002 + A2: 2009
(Non-invasive sphygmomanometers - Part 1: General requirements), EN
1060-3: 1997 + A1: 2005 + A2: 2009 (Non-invasive sphygmomanometers -
Part 3: Supplementary requirements for electro-mechanical blood pressure
measuring systems).
