EXPLANATION OF SYMBOLS ON UNIT .............................................. 35
ELECTROMAGNETIC COMPATIBILITY INFORMATION ...................... 36
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IMPORTANT INFORMATION
Normal blood pressure uctuation
All physical activity, excitement, stress, eating, drinking, smoking, body posture
and many other activities or factors (including taking a blood pressure measurement) will inuence blood pressure value. Because of this, it is mostly unu-
sual to obtain identical multiple blood pressure readings.
Blood pressure uctuates 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 3:00 AM, 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 frequent measurements may cause injury due to blood ow 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 that you obtain
identical blood pressure readings each time.
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 inatable
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
Sphygmomanometer
PACKAGE CONTENTS
1 Blood Pressure Monitor
1 Operation Guide
1 Arm Cuff
1 Soft Storage Case
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 2x60 measurements can be stored in the memory with date
and time stamp. The monitor can also show the average reading of the last
three measurements. The Electronic Sphygmomanometers corresponds
to the below standards: IEC 60601-1Edition 3.1 2012-08/EN 60601-1:2006/
A1:2013 (Medical electrical equipment -- Part 1: General requirements for
basic safety and essential performance), IEC60601-1-2:2014/EN 60601-12:2015 (Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests), IEC80601-2-30:2009+AMD1:2013/EN
80601-2-30:2010/A1:2015 (Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated
non-invasive sphygmomanometers) EN 1060-1: 1995 + A1: 2002 + A2: 2009
(Non-invasive sphygmomanometers - Part 1: General requirements), EN 10603: 1997 + A1: 2005 + A2: 2009 (Non-invasive sphygmomanometers - Part 3:
Supplementary requirements for electro-mechanical blood pressure measuring systems). ISO81060-2 :2013(Non-Invasive Sphygmomanometers - Part 2:
Clinical Validation Of Automated Measurement Type)
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SPECIFICATIONS
1. Product name: Arm Blood Pressure Monitor
2. Model: KD-558
3. Classication: Internally powered, Type BF applied part, IP20, No AP or
Pulse rate: ±5%
Precision of the displayed values:1mmHg
12. Environmental temperature for operation: 10°C~40°C (50°F~104°F)
13. Environmental humidity for operation: ≤90%RH
14. Environmental temperature for storage and transport: -20°C~55°C
(-4°F~131°F)
15. Environmental humidity for storage and transport: ≤90%RH
16. Environmental pressure: 80KPa-105KPa
17. Battery life: Approx 500 times
18. A list of all components belonging to the pressure measuring system, including accessories: Pump,Valve, LCD, Cuff, Sensor
Note: These specications are subject to change without notice.
Batteries storage tempreture: 20±2°C
Batteries storage humidity: 30~70%RH
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.
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5. Measuring on same arm for each measurement.
6. Please always relax at least 1 or 1.5 minutes between measurements
to allow the blood circulation in your arm to recover. Prolonged over-ina-
tion (cuff pressure exceed 300 mmHg or maintained above15 mmHg for
longer than 3 minutes) of the bladder may cause ecchymoma of your arm.
7. Consult your physician if you have any doubt about below cases:
1 The application of the cuff over a wound or inammation diseases;
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 on the arm on the side of a mastectomy or
lymph node clearance;
4 Simultaneously used with other monitoring medical equipments on the
same limb;
5 Need to check the blood circulation of the user.
8. This Electronic Sphygmomanometers 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 meas-
urement.
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. 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
in the procedure of blood pressure measurement, a signal of ‘(♥)’ will be
displayed. Under this condition, the Electronic Sphygmomanometers can
keep function, but the results may not be accurate, it’s suggested that you
consult with your physician for accurate assessment.
There are 2 conditions under which the signal of IHB will be displayed:
1 The coefcient 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.
13. Please do not use the cuff other than supplied by the manufacturer, otherwise it may bring biocompatible hazard and might result in measurement
error.
14. The monitor might not meet its performance specications or cause
safety hazard if stored or used outside the specied temperature and humidity ranges in specications.
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15. Please do not share the cuff with other infective person to avoid cross-infection.
16. This equipment has been tested and found to comply with the limits for a
Class B digital 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.
17. Attention that changes or modication not expressly approved by the party
responsible for compliance could void the user’s authority to operate the
equipment.
18. Measurements are not possible in patients with a high frequency of arrhyth-
mias.
19. The device is not intended for use on neonates, children or pregnant women. (Clinical testing has not been conducted on neonates, children or preg-
nant women.)
20. Motion, trembling, shivering may affect the measurement reading.
21. The device would not apply to the patients with poor peripheral circulation,
noticeably low blood pressure, or low body temperature (there will be low
blood ow to the measurement position).
22. The device would not apply to the patients who use an articial heart and
lung (there will be no pulse)
23. Consult your physician before using the device for any of the following conditions: common arrhythmias such as atrial or ventricular premature beats
or atrial brillation, arterial sclerosis, poor perfusion, diabetes, pre-eclamp-
sia, enal diseases.
24. The patient can be an intended operator.
25. Swallowing batteries and/or battery uid can be extremely dangerous. Keep
the batteries and the unit out of the reach of children and disabled persons.
26 If you are allergic to plastic/rubber, please don’t use this device.
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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.
Avoid the battery uid to get in your eyes. If it should get in your eyes, immediately rinse with plenty of clean water and contact a physician.
The negative terminal of the battery needs to be compressed into the battery compartment properly after horizontal compression of the negative
electrode. The battery is in contact with the spring.
Make sure the battery cover is intact and not damaged before installing
the battery.
The monitor, the batteries and the cuff, must be disposed of according to
local regulations at the end of their usage.
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 by turns. See picture 2&2-1.
Picture 2 Picture 2-1 Picture 2-2
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 rst. 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. Keep on pressing the button “MEM”, the number will
increase fast.
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c. You can turn off the monitor by pressing “START” button when the minute is
blinking, then the time and date is conrmed.
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.
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 dur-
ing blood pressure measurements.
Avoid compression or restriction of the connection tubing during measurement which may cause ination error, or harmful injury due to continuous
cuff pressure
4. 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. If you place the cuff around left arm,position the air
tube in the middle of your arm in line with your middle nger.
If you place the cuff around right arm, apply the cuff
so that the air tube is at the side of your elbow.
d. While seated, place palm upside in front of you on
a at surface such as a desk or table. Position the
air tube in the middle of your arm in line with your
middle nger.
e. The cuff should t comfortably, yet snugly around
your arm. You should be able to insert one nger
between your arm and the cuff.
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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 quiet, calm for 5 minutes before blood pressure measurement.
5. Please keep the cuff clean. If the cuff becomes dirty, remove it from the mon-
itor 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.
6. Do not place the cuff around your arm if the arm has any inammation, acute
diseases, infections skin wounds.
5. Body posture during measurement
Sitting Comfortably Measurement
a. Be seated with your feet at on the oor, and don’t
cross your legs.
b. Place palm upside in front of you on a at 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 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.
6. Taking your blood pressure reading
a. 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. See picture 6. Please contact the service center if segment is miss-
ing.
b. Then the current memory bank (U1 or U2) is blinking. See picture 6-1.
Press “MEM” button to change over to other bank. See picture 6-2.
Conrm your selection by pressing “START” button. The current bank can
also be conrmed automatically after 5 seconds with no operation.
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Picture 6 Picture 6-1 Picture 6-2
ENGLISH
c. After selecting the memory bank, the monitor starts to seek zero pressure.
See picture 6-3.
d. The monitor inates the cuff until sufcient pressure has built up for a meas-
urement. 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 mon-
itor manually.
Note: Please consult a health care professional for interpretation of pressure
measurements.
7. Displaying stored results
a. After the measurement, you can review the measurements in the current
memory bank by pressing button “MEM”. Now the LCD displays the amount
of the results in the current bank. See picture 7.
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30
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. Conrm your selection by pressing “MEM” button. The
current bank can also be conrmed 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.
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 displayed. 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
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Picture 7-8 Picture 7-9
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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
When any result (except average reading of the last three results) is displaying,
keeping on pressing button “MEM” for three seconds, all results in the current
memory bank will be deleted after three “beep”.
LCD will show picture 8, Press the button “MEM” or “START”, the monitor will
turn off.
Picture 8
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 Denitions and classication of blood
pressure levels
SBP
mmHg
<120
120-129
130-139
140-159
160-179
≥180
DBP
mmHg
<80
80-84
85-89
90-99
100-109
≥110
10. Technical alarm description
The monitor will show ‘HI’ or ‘Lo’ as technical alarm on LCD with no delay if
the determined blood pressure (systolic or diastolic) is outside the rated range
specied in part SPECIFICATIONS. In this case, you should consult a physician or check if your operation violated the instructions.
The technical alarm condition (outside the rated range) is present in the factory
and cannot be adjusted or inactivated. This alarm condition is assigned as low
priority according to IEC 60601-1-8. The technical alarm is non-latching and
need no reset. The signal displayed on LCD will disappear automatically after
about 8 seconds.
11. Troubleshooting 1
PROBLEMPOSSIBLE CAUSESOLUTION
LCD Display
shows abnormal
result
The cuff position was not correct
or it was not properly tightened
Body posture was not correct dur-
ing testing
Speaking, arm or body movement, angry, excited or nervous
during testing
Irregular heartbeat (arrhythmia)
Apply the cuff correctly and try
again
Review the “BODY POSTURE
DURING MEASUREMENT” sec-
tions 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
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12. Troubleshooting 2
PROBLEMPOSSIBLE CAUSESOLUTION
LCD shows low battery
symbol
LCD shows “Er 0”
LCD shows “Er 1”Fail to detect systolic pressure
LCD shows “Er 2”Fail to detect diastolic pressure
LCD shows “Er 3”
LCD shows “Er 4”
LCD shows “Er 5”Cuff pressure above 300mmHg
LCD shows “Er 6”
LCD shows “Er 7”EEPROM accessing error
LCD shows “Er 8”Device parameter checking error
LCD shows “Er A”Pressure sensor parameter error
No response when you
press button or load
battery
Low BatteryChange the batteries
Pressure system is unstable
before measurement
Pneumatic system blocked or
cuff is too tight during ination
Pneumatic system leakage or
cuff is too loose during ination
More than 3 minutes with cuff
pressure above 15 mmHg
Incorrect operation or strong
electromagnetic interference
Don’t move and try again
Apply the cuff correctly
and try again
Measure again after ve
minutes. If the monitor
is still abnormal, please
contact the local distributor or the factory
Take out batteries for
ve minutes, and then
reinstall all batteries
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. Clean the monitor with a dry, soft cloth or a soft cloth squeezed well after
moistened with water, diluted disinfectant alcohol, or diluted detergent.
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 qualied technical personnel to repair those parts of equipment which are designated repairably
can be supplied.
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9. The monitor can maintain the safety and performance characteristics for a
minimum of 10,000 measurements or three years, and the cuff can maintain
the performance characteristics for a minimum of 1000 measurements.
10. It is recommended the cuff should be disinfected 2 times every week if
needed (For example, in hospital or in clinique). Wipe the inner side (the
side contacts skin) of the cuff by a soft cloth squeezed after moistened with
Ethyl alcohol (75-90%), then dry the cuff by airing.
11. The monitor requires 6 hours to warm from the minimum storage tempera-
ture between uses until the monitor is ready for its INTENDED USE when
the ambient temperature is 20°C.
12. The monitor requires 6 hours to cool from the maximum storage tempera-
ture between uses until the monitor is ready for its INTENDED USE when
the ambient temperature is 20°C.
13. No servicing/maintenance while the monitor is in use.
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EXPLANATION OF SYMBOLS ON UNIT
Product code
Lot number
Keep in a cool, dry place
Keep away from sunlight
Manufacturer
Date of manufacture
Medical Device complies with Directive 93/42/EEC
Caution: read instructions (warnings) carefully
WEEE disposal
Follow instructions for use
Authorized representative in the European community
Serial number
Type BF applied part
IP20Covering Protection rate
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ELECTROMAGNETIC COMPATIBILITY
INFORMATION
Table 1
Emission
PhenomenonComplianceElectromagnetic environment
RF emissionsCISPR 11
Harmonic distortionIEC 61000-3-2
Voltage uctuations and icker IEC 61000-3-3
Group 1,
Class B
Class A
Compliance
Table 2
Enclosure Port
PhenomenonBasic EMC standardImmunity test levels
Electrostatic
Discharge
Radiated RF EM eldIEC 61000-4-310V/m
Proximity elds from RF
wireless communications
equipment
Rated power frequency
magnetic elds
IEC 61000-4-2±8 kV contact
IEC 61000-4-3Refer to table 3
IEC 61000-4-830A/m
Home healthcare environment
Home healthcare environment
Home healthcare environment
Home Healthcare Environment
±2kV, ±4kV, ±8kV, ±15kV air
80MHz-2.7GHz
80% AM at 1kHz
50Hz or 60Hz
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Table 3
Proximity elds from RF wireless communications equipment
Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of this equipment by bringing
it to a specic recycling point for electric and electronic equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
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