Kinetik BPM5TL Series User Manual

ＢＰＭ５ＴＬ Ｖ２．
BPM5TL Series
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
Fully Automatic
measurement
8. Memory volume: 2 x 60 with time and date stamp
Blood Pressure
9. Power source: batteries: 4 × 1.5V
10. Measurement range:
Monitor
Cuff pressure: 0-300 mmHg
Systolic: 60-260 mmHg
User Manual
Diastolic: 40-199 mmHg
Pulse rate: 40-180 beats/minute
Index

Important Information

Body Posture During Measurement
2 16 11. Accuracy:
Contents and Display Indicators 3

Taking Your Blood Pressure Reading

17 Pressure: ±3 mmHg
Pulse rate: ±5%
Intended Use 4

Displaying Stored Results

19
12. Environmental temperature for operation: 10ºC～40ºC(50ºF～104ºF)
Contraindication 4

Deleting Measurements from the Memory

21
13. Environmental humidity for operation: ≤90%RH

Product Description

5 Assessing High Blood Pressure for Adults 22
14. Environmental temperature for storage and transport: -20ºC～55C(-4ºF

Specifications

6

Troubleshooting (1)

23 ～131ºF)
15. Environmental humidity for storage and transport: ≤90%RH
Notice

Troubleshooting (2)

24
8
16. Environmental pressure: 80KPa-105KPa

Setup and Operating Procedures

12 Maintenance 25
17. Battery life: Approx 500 measurements

Battery Loading

12 Explanation of Symbols on Unit 26

Clock and Date Adjustment

13 Electromagnetic Compatibility Information 28
Connecting the Cuff to the Monitor 14 Note: These specifications are subject to change without notice.

Applying the Cuff

15
Important Information
Normal Blood Pressure Fluctuation
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
All physical activity, excitement, stress, eating, drinking, smoking, body
measurement.
posture and many other activities or factors (including taking a blood
3. The cuff should be placed at the same level as your heart.
pressure measurement) will influence blood pressure value. Because of
4. During measurement, neither speak nor move your body and arm.
this, it is unusual to obtain identical multiple blood pressure readings.
5. Measure on same arm for each measurement.
Blood pressure fluctuates continually ----- day and night. The highest value
6. Please always relax at least 1 to 1.5 minutes between measurements to
usually appears in the daytime and lowest one usually at midnight. allow the blood circulation in your arm to recover. Prolonged over-inflation
(cuff pressure exceeds 300 mmHg ) of the bladder may cause bruising or
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. swelling of your arm.
7. Consult your physician if you have any doubt about the following :
Considering the above information, it is recommended that you measure
1) The application of the cuff over a wound or inflammation.
your blood pressure at approximately the same time each day.
2) The application of the cuff on any limb where intravascular access or
Too many measurements may cause injury due to blood flow interference,
therapy, or an arterio-venous (A-V) shunt, is present.
please always relax a minimum of 1 to 1.5 minutes between measurements
3) The application of the cuff over the arm on the side of a mastectomy.
to allow the blood circulation in your arm to recover. It is rare to obtain
4) Simultaneously used with other monitoring medical equipment on the
identical blood pressure readings each time. same limb.
5) If you suffer with poor circulation. - 8 -
Contents and Display Indicators
Low Battery Indicator
8. This Electronic Sphygmomanometer is designed for adults and should
Ready to inflate indicator
Systolic Pressure never be used on infants or young children. Consult your physician or other
Blood Pressure Level health care professionals before use on older children.
Classification Indicator
9. Do not use this unit in a moving vehicle. This may result in erroneous
Irregular Hearbeat
measurement.
Symbol
Diastolic Pressure/Pulse 10. Blood pressure measurements determined by this monitor are
Rate Display(Alternating)
Memory Indicator
equivalent to those obtained by a trained observer using the
Date/Time Display(Alternating) cuff/stethoscope auscultation method, within the limits prescribed by the
American National
LCD display
sphygmomanometers.
MEM button 11. For information regarding potential electromagnetic or other
interference between the blood pressure monitor and other devices
START button
together with advice regarding avoidance of such interference, please see
part ELECTROMAGNETIC COMPATIBILITY INFORMATION.
Cuff
12. If Irregular Heartbeat (IHB) brought by common arrhythmias is detected
during a measurement, the
Cuff tube plug
and try again after a few minutes.
Blood Pressure level
Rubber tube
classification indicator
Intended Use
Note: This monitor is designed to detect Premature Ventricular
This Fully Automatic Electronic Sphygmomanometer is for use by medical
Contractions, also known as a Premature Ventricular Complex (or
complexes), Ventricular
professionals or at home and is a non-invasive blood pressure
complexes), Ventricular Premature Beats, or Extrasystoles. It is not
measurement system intended to measure the diastolic and systolic blood
designed to detect Atrial Fibrillation or Atrial Premature
pressures and pulse rate of an adult individual by using a non-invasive Beats.
13. Please only use the cuff supplied.
technique in which an inflatable cuff is wrapped around the upper arm. The
14. This monitor might not meet its performance specifications or cause a
cuff circumference is limited to 22cm-48cm (approx. 8 21/32"~18 29/32"). safety hazard if stored or used outside the specified temperature and
humidity ranges in the specifications section.
Contraindication
15. To avoid cross contamination, do not share this cuff with anyone
suffering with a contagious illness.
It is inappropriate for people with serious arrhythmia to use this
Electronic Sphygmomanometer.
Product Description
Based on Oscillometric methodology and a silicon integrated pressure
16. This blood pressure monitor is verified by auscultatory method. It is
sensor, blood pressure and pulse rate can be measured automatically and recommended
non-invasively. The LCD display will show blood pressure and pulse rate. SP-10:2002+A1:2003+A2: 2006 for details of verification method if you
The most recent 60 measurements for two users can be stored in the need.
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).
- 5 -
By Paul Aylett at 5:08 pm, Sep 11, 2013
Setup and Operating Procedures
Specifications
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.
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
SIZE AA
according to local regulations at the end of their usage.
- 12 -
- 6 -
Specifications
2. Clock and Date Adjustment
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
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.
- 7 - - 13 -
d. The monitor will turn off automatically after 1 minute of no operation, with
Notice
the time and date unchanged.
e. Once you change the batteries, you should adjust the time and date.
3. Connecting the Cuff to the Monitor
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.
- 14 -
4. Applying the Cuff
Notice
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
Standard Institute, Electronic or automated
your arm. You should be able to insert one finger
between your arm and the cuff.
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
will be displayed. Please ignore the results
tube during measurement.
4. Stay quiet, calm for 5 minutes before blood pressure measurement.
- 9 - - 15 -
Notice
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.
Premature Contractions (or complex or
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.
- 10 - - 16 -
Notice 6. Taking Your Blood Pressure Reading
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
that you check annex B of ANSI/AAMI
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.
picture 6 picture 6-1
c. After selecting the memory bank, the monitor starts to seek zero
pressure. See picture 6-3.
- 11 - - 17 -
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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.
picture 6-3 picture 6-4 picture 6-5
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 -
7. Displaying Stored Results
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.
picture 2-2
picture 7 picture 7-1 picture 7-2
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 -
picture 7-3 picture 7-4 picture 7-5
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.
picture 7-6 picture 7-7
- 20 -
1-2 cm
picture 7-8 picture 7-9
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.
8. Deleting Measurements from the Memory
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. picture 8
- 21 -
9. Assessing High Blood Pressure for Adults
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.
WHO/ISH Definitions and Classification of Blood Pressure Levels
- 22 -
Troubleshooting (1)
Problem Possible Cause Solution
The cuff position was not
Apply the cuff correctly and
correct or it was not properly
try again
tightened
Review the "BODY POSTURE
Body posture was not correct
DURING MEASUREMENT"
during testing sections of the instructions and
LCD Display shows re-test.
abnormal result
Speaking, arm or body Re-test when calm and without
movement, angry, excited or
speaking or moving during the
nervous during testing
test
picture 6-2
It is inappropriate for people with
Irregular heartbeat
serious arrhythmia to use this
(arrhythmia)
Electronic Sphygmomanometer.
- 23 -
版 本 Ｖ３．０
设计
公 差 ±１．０ｍｍ
表面处理 无
Troubleshooting (2)
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer's declaration - electromagnetic immunity
Problem Possible Cause Solution
The [ BPM5TL ] is intended for use in the electromagnetic environment specified below.
LCD shows low
The customer or the user of the [ BPM5TL ] should assure that it is used in such an environment.
Low Battery Change the batteries
battery symbol
Pressure system is unstable IMMUNITY IEC 60601test
LCD shows "Er 0"
before measurement
test level
Don't move and try again.
LCD shows "Er 1" Fail to detect systolic pressure
LCD shows "Er 2" Fail to detect diastolic pressure
Pneumatic system blocked or
LCD shows "Er 3"
cuff is too tight during inflation Apply the cuff correctly and
try again
Pneumatic system leakage or
LCD shows " Er 4 "
cuff is too loose during inflation
LCD shows " Er 5 "
Cuff pressure above 300mmHg
Measure again after five
More than 3 minutes with cuff
pressure above 15 mmHg minutes. If the monitor is Radiated RF 3 V/m 80 MHz
IEC to 2.5 GHz
still abnormal, please
LCD shows " Er 7 " EEPROM accessing error
contact the local distributor 61000-4-3
LCD shows " Er 8 " Device parameter checking error
or the factory.
LCD shows " Er A " Pressure sensor parameter error
No response when you Take out batteries for five
Incorrect operation or strong
press button or load minutes, and then reinstall
electromagnetic interference.
battery. all batteries.
To be continued
- 24 -
Maintenance
continued
IMMUNITY IEC 60601test
1. Do not drop this monitor or subject it to strong impact. test level
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
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
moistened with water, diluted disinfectant alcohol, or diluted detergent.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
7. This blood pressure monitor is calibrated at the time of manufacture. If affected by absorption and reflection from structures, objects and people.
the blood pressure monitor is used according to the instructions, periodic 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
recalibration is not required. If at any time you question the accuracy of the
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
measurement, please contact the retailer immediately. 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
8. The monitor can maintain the safety and performance characteristics for
exceeds the applicable RF compliance level above, the [ BPM5TL ] should be observed to
a minimum of 10,000 measurements or three years, the cuff can maintain
verify normal operation. If abnormal performance is observed, additional measures may be
the performance characteristics for a minimum of 1000 measurements.
necessary, such as re-orienting or relocating the [ BPM5TL ].
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
- 25 -
9. It is recommended the cuff should be disinfected twice a week if needed
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
(for example, in a hospital or in a clinic). Wipe the inner side of the cuff with
Recommended separation distances between
a soft cloth moistened with Ethyl Alcohol (75-90%), then dry the cuff by
portable and mobile RF communications equipment and the [BPM5TL]
airing. BPM5TL
The [ ] is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the [
Explanation of Symbols on Unit electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the [
below, according to the maximum output power of the communications equipment.
Rated maximum
Symbol for " THE OPERATION GUIDE MUST BE READ"
output
power of transmitter
Symbol for "WARNING" W
0,01
0,1
Symbol for "TYPE BF APPLIED PARTS" (The cuff is type BF applied part)
1
Symbol for "ENVIRONMENT PROTECTION – Waste electrical products should not be
10
disposed of with household waste. Please recycle where facilities exist. Check with
100
your local Authority or retailer for recycling advice".
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
Symbol for "MANUFACTURER"
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
Symbol for "COMPILES WITH MDD93/42/EEC REQUIREMENTS" applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
- 26 -
Symbol for "DATE OF MANUFACTURE"
Symbol for "EUROPEAN REPRESENTATIVE"
SN
Symbol for "SERIAL NUMBER"
Symbol for "KEEP DRY"
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. ,
- 27 -
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
The [BPM5TL] uses RF energy only for its internal
function. Therefore, its RF emissions are very low
RF emissions
Group 1
and are not likely to cause any interference in nearby
CISPR 11
electronic equipment.
RF emissions:
Class B The [BPM5TL] is suitable for use in all establishments
CISPR 11
other than domestic and those directly connected to
Harmonic the public low-voltage power supply network that
supplies buildings used for domestic purposes.
emissions: Not applicable
IEC 61000-3-2
Voltage
fluctuations/
Not applicable
flicker emissions:
IEC 61000-3-3
- 28 -
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 IEC 60601test Compliance Electromagnetic
test level level environment - guidance
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete
or ceramic tile. If floors are
discharge ± 8 kV air ± 8 kV air
covered with synthetic material,
(ESD)
the relative humidity should be
IEC
at least 30 %.
61000-4-2
Power 3 A/m 3 A/m
Power frequency magnetic fields
frequency
should be at levels characteristic
(50/60 Hz) of a typical location in a typical
commercial or hospital
magnetic field
environment.
IEC
61000-4-8
- 29 -
审核 批准
Table 3
Compliance
Electromagnetic environment - guidance
level
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：
d = P 80 MHz to 800 MHz
3 V/m 1.2
d = 2.3 P
800 MHz to 2,5 GHz
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).
- 30 -
Table 3
Compliance
Electromagnetic environment - guidance
level
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey, a should be less than the
b
compliance level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
- 31 -
Table 4
BPM5TL ] can help prevent
BPM5TL ] as recommended
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
d = 1.2 P d = 1.2 P d = 2.3 P
0.12 0.12 0.23
0.38 0.38 0.73
1.2 1.2 2.3
3.8 3.8 7.3
12 12 23
- 32 -
KINETIK BPM5TL UK IB 20130910
ＫＩＮＥＴＩＫ ＢＰＭ５ＴＬ Ｖ２．０