BodyTalk KD-5962 User manual

Fully Automatic Arm Cuff Blood Pressure Monitor KD-5962
(ELECTRONIC SPHYGMOMANOMETER)
OPERATION GUIDE
INDEX
IMPORTANT INFORMATION .........................................................................1
CONTENTS AND DISPLAY INDICATORS.....................................................1
INTENDED USE..............................................................................................2
CONTRAINDICATION.....................................................................................2
PRODUCT DESCRIPTION..............................................................................2
SETUP AND OPERATING PROCEDURES....................................................3
1. BATTERY LOADING ...............................................................................3
2. TOUCH SCREEN SWITCH......................................................................3
3. CLOCK AND DATE ADJUSTMENT........................................................3
4. VOICE SETTING......................................................................................4
5. CONNECTING THE CUFF TO THE MONITOR.......................................4
6. APPLYING THE CUFF.............................................................................4
7. BODY POSTURE DURING MEASUREMENT.........................................5
8. TAKING YOUR BLOOD PRESSURE READING.....................................5
9. DISPLAYING STORED RESULTS ..........................................................6
10. DELETING MEASUREMENTS FROM THE MEMORY ...........................6
11. ASSESSING HIGH BLOOD PRESSURE FOR ADULTS ........................6
12. TROUBLESHOOTING (1)........................................................................7
13. TROUBLESHOOTING (2)........................................................................8
SPECIFICATIONS...........................................................................................8
NOTICE ...........................................................................................................9
MAINTENANCE ............................................................................................11
EXPLANATION OF SYMBOLS.....................................................................11

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 mostly 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.
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 that you obtain identical blood pressure readings
each time.
CONTENTS AND DISPLAY INDICATORS

INTENDED USE
Fully Automatic electronic blood pressure monitor 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”)..
CONTRAINDICATION
It is inappropriate for people with serious arrhythmia to use this electronic blood pressure
monitor.
PRODUCT DESCRIPTION
Based on Oscillometric methodology and 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 can be stored in the
memory with date and time stamp. The voice function will ease the operation. The Electronic
Blood Pressure Monitor corresponds to the below standards:
EN 60601-1:1990+A1:1993+A2:1995 (Medical electrical equipment-Part1: General
requirements for safety), EN 60601-1-2:2007 (Medical electrical equipment-Part1: General
requirements for safety; 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), ANSI/AAMI SP-10:2002+A1:2003+A2:2006.
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SETUP AND OPERATING PROCEDURES
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
relevant damage of battery leakage.
The monitor, the batteries and the cuff, must be disposed of according to local
regulations at the end of their usage.
2. TOUCH SCREEN SWITCH
Your monitor has a touch screen as equipment. Be careful not
to touch the screen by mistake. Keep the touch screen switch
in “OFF” position when the monitor is not in use to avoid
unintentional operation.
3. 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.
b. While the monitor is in Clock Mode, press the “START” and “MEM” button
simultaneously for two seconds (touch screen switch in ON position), the month
will blink at first. 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. Keep on pressing the button "MEM", the number will increase fast.
c. You can turn off the monitor by pressing “START” button when the minute is
blinking, then the time and date is confirmed.
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 readjust the time and date.
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4. VOICE SETTING
a. Switch the monitor on by using the touch screen switch (ON position).
b. If the number of language is only one, LCD will twinkle “ON” and “--” circularly.
Here “ON” represents opening the voice function and “--” represents closing the
voice function.
c. Voice volume setting: Once you have selected a
language, keeping on pressing the button “MEM” again.
A column of bar will appear on the left side of the LCD.
The higher the bars, the louder the volume. Release
button “MEM” at your desirable volume for confirmation.
5. 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.
6. APPLYING THE CUFF
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.
Note:
1. Please refer to the cuff circumference range in “SPECIFICATIONS” to make
sure that the appropriate cuff is used.
2. Measuring 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 still, calm for 5 minutes before blood pressure measurement.
5. Please keep the cuff clean. If the cuff becomes dirty, remove it from the monitor
and clear it by hand in a mild detergent, then rinse it thoroughly in cold water.
Never dry the cuff in clothes dryer or iron it. Clean the cuff after the usage of
every 200 times is recommended.
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6. Do not place the cuff around your arm if the arm has any inflammation, acute
diseases, infections skin wounds.
7. BODY POSTURE DURING MEASUREMENT
Sitting Measurement
a. Be seated with your feet flat on the floor.
b. Place palm upside in front of you on a flat surface such as
a desk or table
c. The cuff should be at the same level as your heart.
Lying Down Measurement
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.
8. TAKING YOUR BLOOD PRESSURE READING
a. Switch the monitor on by using the touch screen switch (ON position).
b. After applying the cuff and your body is in a comfortable
position, press the “START” button. A beep is heard and all
display characters are shown for self-test. You can check
the LCD display according to the right picture. Please
contact the service center if segment is missing.
c. If the monitor has stored results, the LCD will momentarily
display the most recent one. If no result has been stored,
zero will appear on LCD.
d. If the voice function is switched on, the monitor will speak
out measurement tips.
e. Then 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. The blood pressure classification indicator and Irregular heartbeat
symbol (if any) will blink on the screen. If the voice function is on, it will announce
the measurement result. The result will be automatically stored in the monitor.
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f. 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.
g. 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.
9. DISPLAYING STORED RESULTS
a. Switch the monitor on by using the touch screen switch (ON
position).
b. In Clock Mode, press “MEM” button, the last result will be
displayed with date and time. Irregular heartbeat symbol (if
any) and the indicator of blood pressure classification will blink
at the same time. Press “MEM” button repeatedly to review the
results measured previously.
c. If the voice function is on, the monitor will announce each result in the memory.
d. When displaying the stored results, the monitor will turn off automatically after 2
minutes of no operation. You can also press the button “START” to turn off the monitor
manually.
10. DELETING MEASUREMENTS FROM THE MEMORY
When any result is displaying, keeping on pressing button “MEM” for three
seconds, all results will be deleted after three “beep”. Press the button
“MEM” or “START”, the monitor will turn off.
11. 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.
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Note: It is not intended to provide a basis of any type of rush toward emergency
conditions/diagnosis based on the color scheme and that the color scheme is meant only
to discriminate between the different levels of blood pressure.
12. TROUBLESHOOTING (1)
PROBLEM POSSIBLE CAUSE SOLUTION
LCD Display shows
battery symbol Low Battery Change all the batteries
Arm or electronic blood
pressure monitor was
moved during testing
Re-test taking care to not move
your arm or the electronic blood
pressure monitor
The cuff does not inflate
properly or pressure falls
quickly during testing
Make certain the rubber tube is
fully inserted into the electronic
blood pressure monitor
LCD Display shows
“EE”
Irregular heartbeat
(arrhythmia)
It is inappropriate for people with
serious arrhythmia to use this
electronic blood pressure monitor.
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13. TROUBLESHOOTING (2)
PROBLEM POSSIBLE CAUSE SOLUTION
LCD Display shows
“EE”
The cuff was not properly
applied or the rubber
tube was bent or
pressed.
Review the cuff applying and
testing sections of the instructions
and re-test.
The cuff position was not
correct or it was not
properly tightened
Apply the cuff correctly and try
again
Body posture was not
correct during testing
Review the body posture and
testing sections of the instructions
and re-test.
LCD Display shows
abnormal result
Speaking, arm or body
movement, angry,
excited or nervous during
testing
Re-test when calm and without
speaking or moving during the test
No response when you
press button or load
battery
Incorrect operation, or
strong electromagnetic
interference
Take out batteries for five minutes,
and then reinstall all batteries.
SPECIFICATIONS
1. Product name: bodytalk Talking Upper Arm Blood Pressure Monitor KD-5962
2. Model: Upper Arm Blood Pressure Monitor KD-5962
3. Classification: Internally powered, Type B applied part,IPX0,No AP or APG,Continuous
operation
4. Machine size: approx.142mm×98mm×51mm (5 19/32” x 3 27/32” x 2”)
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. 314g(15 1/16oz.) (exclude batteries)
7. Measuring method: Oscillometric method, automatic inflation and measurement
8. Memory volume: 60 times with time and date stamp
9. Power source: DC:6V 600mA, batteries: 4 ×1.5V SIZE AA
10. Range of cuff pressure: 0-295mmHg
11. Range of measurement: 30-280mmHg
12. Pressure accuracy: ±3mmHg
13. Pulse rate range: 40-180/min, accuracy: ±5%
14. Environmental temperature for operation: 5℃~40℃(41℉~104℉)
15. Environmental humidity for operation: <90%RH
16. Environmental temperature for storage and transport: -20℃~55℃(-4℉~131℉)
17. Environmental humidity for storage and transport: <95%RH
18. Environmental pressure: 80kPa-105kPa
19. Battery life: Approx.2 months with new alkaline batteries and 3-min. usage per day.
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20. List of all components belonging to the pressure measuring system, including: Pump,
Valve, LCD, Cuff and Sensor. If you want to change these components, please contact
service center.
NOTICE
1. Stay still, calm and rest for 5 minutes before blood pressure measurement.
2. The cuff should be placed at the same level as your heart.
3. During measurement, neither speak nor move your body and arm.
4. Measuring on same arm for each measurement.
5. Please always relax at least 1 or 1.5 minutes between measurements to allow the blood
circulation in your arm to recover. Prolonged over-inflation (cuff pressure exceed 300 mmHg
or maintained above15 mmHg for longer than 3 minutes) of the bladder may cause ecchymoma
of your arm.
6. Remove the batteries if the monitor is not be used for a month or more to avoid damage of
battery leakage.
7. This electronic blood pressure monitor 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.
8. 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. 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.
9. 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.
10. If Irregular Heartbeat (IHB) brought by common arrhythmias is detected in the procedure
of blood pressure measurement, a signal of will be displayed. Under this condition,
the electronic blood pressure monitor will function but it’s recommended that you consult
with your physician if the IHB symbol is displayed on a regularly.
There are 2 conditions under which the signal of IHB will be displayed:
1) The coefficient of variation (CV) of pulse period >25%.
2) The difference of adjacent pulse period≥0.14s, and the number of such pulse takes
more than 53 percentage of the total number of pulse.
11. Please do not use the cuff other than supplied by the manufacturer, otherwise it may bring
biocompatible hazard and might result in measurement error.
12. The monitor might not meet its performance specifications or cause safety hazard if stored
or used outside the specified temperature and humidity ranges in specifications.
13. Please do not share the cuff with other infective person to avoid cross-infection.
14. Please note that changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to operate the equipment.
15. This equipment has been tested and found to comply with the limits for a Class B digital
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device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following
measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver
is connected.
—Consult the dealer or an experienced radio/TV technician for help.
16. Medical AC adapter which output is DC 6.0V 600mA and complied with IEC 60601-1/EN
60601-1 and IEC 60601-1-2/EN 60601-1-2(UL 60601-1 and UL 60601-1-2)is suitable for
this monitor. Please note that the monitor jack size: hole Φ5.5mm, center pin Φ2.0mm.
Please pay attention to polarity.
If the AC adapter is abnormal, please change the adapter.
Note: Do not pull out the adapter when you are using the monitor!
Do not use any other type of AC adapter as it may harm the monitor!
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MAINTENANCE
1. Do not drop this monitor or subject it to strong impact.
2. Avoid high temperature and solarization. Do not immerse the monitor in water as this will
result in damage to the monitor.
3. If this monitor is stored near freezing, 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. It is recommended the performance should be checked every 2 years or after repair.
Please contact the service center.
7. If the monitor becomes dirty, please clear it with a soft dry cloth. Do not use any abrasive
or volatile cleaners.
8. No component can be maintained by user in the monitor. The circuit diagrams,
component part lists, descriptions, calibration instructions, or other information which will
assist the user’s appropriately qualified technical personnel to repair those parts of
equipment which are designated repairably can be supplied by us.
9. The monitor can maintain the safety and performance characteristics for a minimum of
10,000 measurements or three years.
EXPLANATION OF SYMBOLS
Symbol for” THE OPERATION GUIDE MUST BE READ”
The sign background colour: blue
The sign graphical symbol: white
Symbol for “CAUTION”
Symbol for “TYPE B APPLIED PARTS”
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 “COMPILES WITH MDD93/42/EEC REQUIREMENTS”
Symbol for “Polarity of d.c. power connector”
Manufactured by Andon Health Co Ltd
No 3, Jingping Street YaAn Road
Tianjin Nankai 300190
China
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