User Manual

FCC ID: ZRY926

Users Manual

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FCCID_3245784

andon onxpezesvevervio                         Operaton Guide




             Operation Guide
                           (V1.0)



          Product/project name: Blood Pressure Monitor

          Model     name:     KD—926

          Project   number:




          Drafted    by:                Dale

          Reviewed by:                  Dale

          Approved by:                 Date


                    DN:KD-926-SMSY01 V1.0                                                    Operation Guide

                                           MODEL KD-926

                           Wireless Blood Pressure Monitor
                                (ELECTRONIC SPHYGMOMANOMETER)

                                       OPERATION GUIDE
__________________________________________________________________________
                                                    INDEX

IMPORTANT INFORMATION ......................................................................... 2
CONTENTS AND DISPLAY INDICATORS ..................................................... 2
INTENDED USE .............................................................................................. 3
CONTRAINDICATION ..................................................................................... 3
PRODUCT DESCRIPTION .............................................................................. 3
SPECIFICATIONS ........................................................................................... 4
NOTICE ........................................................................................................... 4
SETUP AND OPERATING PROCEDURES .................................................... 6
1. DOWNLOAD THE FREE APP .................................................................... 6
2. BATTERY LOADING AND AC ADAPTER LOADING ................................ 6
3. CLOCK AND DATE ADJUSTMENT ........................................................... 7
4. CONNECTING THE CUFF TO THE MONITOR .......................................... 8
5. APPLYING THE CUFF ................................................................................ 8
6. BODY POSTURE DURING MEASUREMENT ............................................ 9
7. TAKING YOUR BLOOD PRESSURE READING ........................................ 9
8. DISPLAYING STORED RESULTS ........................................................... 10
9. SYNCHRONIZING STORED RESULTS ................................................... 10
10. DELETING MEASUREMENTS FROM THE MEMORY ........................... 11
11. ASSESSING HIGH BLOOD PRESSURE FOR ADULTS ....................... 11
12. TECHNICAL ALARM DESCRIPTION ..................................................... 12
13. TROUBLESHOOTING (1) ....................................................................... 12
14. TROUBLESHOOTING (2) ....................................................................... 13
MAINTENANCE ............................................................................................ 14
EXPLANATION OF SYMBOLS ON UNIT ..................................................... 14
WARRANTY INFORMATION ........................................................................ 15
SERVICE CENTER ....................................................................................... 15
IMPORTANT INFORMATION REQUIRED BY THE R&TTE ........................ 15
ELECTROMAGNETIC COMPATIBILITY INFORMATION ............................ 16




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                 DN:KD-926-SMSY01 V1.0                                         Operation Guide
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
3:00 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 flow interference, please always
relax a minimum moment 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




                                               2/16


andon DN:KD—926—SMSYO1 V1.0                                                  Operation Guide


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 22em—42em(approx.8 21/32" —16 17/32" ).


CONTRAINDICATION


  A It is inappropriate for people with serious arrhythmia to use this Electronic
        Sphygmomanometer.


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 2X 60 measurements can be stored in the
memory with date and time stamp. The Electronic Sphygmomanometer corresponds to the
below standards:     IEC 60601—1:2005 +A41:2012(E)/EN 60601—1: 2006/A11;: 2011 (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),
IEC80601—2—30:2009+AMD1: 2013/EN 80601—2—30:2010/¥41: 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 +            A2: 2009
(Non—invasive sphygmomanometers — Part 1: General requirements), EN 1060—3: 1997 + A2:
2009 (Non—invasive sphygmomanometers — Part 3: Supplementary requirements for
electro—mechanical blood pressure measuring systems).




                                              316


   O n C\l-/on DN:KD—926—SMSYO1 V1.0                                                  Operation Guide
  SPECIFICATIONS
  1. Product name: Wireless Blood Pressure Monitor
  2.         Model: KD—926
  3.         Classification: Internally powered, Type BF applied part,lP20,No AP or APG, Continuous
             operation
             Machine size: Approx. 145 mm x90 mm x 51mm
® ~ o o A




             Cuff circumference: 8—21/32" to 16—17/32"(22em—42cm)
             Weight: Approx. 234q (8 1/40z.) (exclude cuff)
             Measuring method: Oscillometric method, automatic inflation and measurement
             Memory volume: 2X 60 times with time and date stamp
          Power source: batteries: 4x1.5V === SIZE AA, DC 6V 600mA
3 ©




       0. Measurement range:
                  Cuff pressure: 0—300mmHg
                  Systolic:        60—260mmHg
                  Diastolic:       40—199mmHg
                  Pulse rate:      40—180 beats/minute
   11. Accuracy:
                  Pressure:        +3mmHg
                  Pulse rate:      £5%
   12. Environmental temperature for operation: 10°C—40°C(50°F —104°F)
   13. Environmental humidity for operation:             <85%RH
   14. Environmental temperature for storage and transport: —20°C~50°C(—4°F ~122°F )
   15. Environmental humidity for storage and transport: <85%RH
   16. Environmental pressure: 8OkPa—105kPa
   17. Battery life: Approx 300 times.
   18. Wireless Connection:
                   Smart Bluetooth
                   Frequency Band: 2.400~2.4835GHz
   19. All components belonging to the pressure measuring system, including: Pump, Valve, LCD,
             Cuff, Sensor
            Note: These specifications are subject to change without notice.


  NOTICE
   1.        Read all of the information in the operation guide and any other literature in the box before
             operating the unit.
             Stay still, calm and rest for 5 minutes before blood pressure measurement.
9 go m m




             The cuff should be placed at the same level as your heart.
             During measurement, neither speak nor move your body and arm.
             Measuring on same arm for each measurement.
             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.
  7.         Consult your physician if you have any doubt about below cases:


                                                         416


andon DN:KD—926—SMSYO1 V1.0                                                     Operation Guide
       1) The application of the cuff over a wound or inflammation 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;
       4) Simultaneously used with other monitoring medical equipments on the same limb;
       5) Need to check the blood circulation of the user.
      A 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.
      Do not use this unit in a moving vehicle, This may result in erroneous measurement.
  . 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 Sphygmomanometer 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 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.
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.   AThe monitor might not meet its performance specifications or cause safety hazard if
      stored or used outside the specified temperature and humidity ranges in specifications.
15. A 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.


                                                516


andon DN:KD—926—SMSYO1 V1.0                                                   Operation Guide
       —Consult the dealer or an experienced radio/TV technician for help.
17. Medical AC adapter which output is DC 6.0V 600mA and complied with IEC 60601—1/EN
     60601—1/UL 60601—1 and IEC 60601—1—2/EN 60601—1—2/UL 60601—1—2 is suitable for this
     monitor. Please note that the monitor jack size: hole ©®5.5mm, center pin ®2.0mm. Please
     pay attention to polarity.
18. Measurements are not possible in patients with a high frequency of arrhythmias.
19. The device is not intended for use on neonates, children or pregnant women. (Clinical
     testing has not been conducted on neonates, children or pregnant 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 flow to the measurement
     position).
22. The device would not apply to the patients who use an artificial 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 fibrillation,
     arterial sclerosis, poor perfusion, diabetes, pre—eclampsia, enal diseases.


SETUP AND OPERATING PROCEDURES
1. DOWNLOAD THE FREE APP
     Prior to first use, download and install the Andon App from the App Store(iOS device) or
     Google Play(Android device). Use keyword search terms "mHealth".
2.   BATTERY LOADING AND AC ADAPTER 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.
     AAvoid the battery fluid to get in your eyes. If it should get in your eyes, immediately
     rinse with plenty of clean water and contact a physician.
     d.   If you use the AC adapter, please make sure the monitor turn off or no batteries. Put
          the connector plug of the adapter into the socket as the picture, Then plug the adapter
          to AC outlet. When disconnect the AC Adapter:
          Remove the AC Adapter from the electrical outlet;
          Remove the AC Adapter plug from the monitor socket.

     A Do not plug or unplug the power cord into the electrical outlet with wet hands.


     A Do not overload power outlets. Plug the device into the appropriate voltage outlet.


     A If the AC adapter is abnormal, please change the adapter.


     A Do not pull out the adapter when you are using the monitor.

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                DN:KD-926-SMSY01 V1.0                                      Operation Guide

         Do not use any other type of AC adapter as it may harm the monitor.


             The monitor, the batteries and the cuff, must be disposed of according to local
         regulations at the end of their usage.


3. CLOCK AND DATE ADJUSTMENT
    a. Once you install the battery,the Blood Pressure Monitor will enter Clock and Date
           Adjustment Mode. When you turn off the monitor, it will enter Clock Mode, and
           LCD will display time and date.
    b. While the monitor is in Clock Mode , adjustment can be reached by pressing both
           the “START/STOP” and “MEM” button for 1 seconds in Clock Mode to change the
           time.See picture3.
    c.     In Clock and Date Adjustment Mode , the time format will blink at first , see
           picture3-1 .The default time format is 24h(Europe Version) and the default clock
           and date is 2016-1-1 12:00.
    d. Press the button “START/STOP” repeatedly, the year (first usage: default is 2016,
           range is 2016~2099), month, day, hour and minute will blink in turn, see picture3-
           2&3-3 & 3-4 & 3-5 & 3-6. While the number is blinking, press the button “MEM” to
           increase the number, keep on pressing the button "MEM", the number will
           increase faster.




              Picture 3             Picture 3-1          Picture 3-2           Picture 3-3




             Picture 3-4          Picture 3-5           Picture 3-6
    e. During adjusting clock and date, the monitor will go back to Clock Mode
           automatically when no button will be pressed within 60 seconds.
    f.     You can turn off the monitor by pressing “START/STOP” button when the minute
           is blinking, then the time and date is confirmed.
     Note:
         3.1 The clock format could be set by user.


                                             7/16


            K            DN:KD—926—SMSYO1 V1.0                                     Operation Guide
             3.2 Table 1 instructs the conversion relations between 24 hour format and 12 hour
                     format.
                                                    Table 1
          24 hour format           12 hour format             24 hour format    12 hour format
                  0:00               12:00 AM                     12:00            12:00 PM
                  1:00                1:00 AM                     13:00               1:00 PM
                  2:00                2:00 AM                     14:00               2:00 PM
                  3:00                3:00 AM                     15:00               3:00 PM
                  4:00                4:00 AM                     16:00               4:00 PM
                  5:00                5:00 AM                     17:00               5:00 PM
                  6:00                6:00 AM                     18:00               6:00 PM
                  7:00                7:00 AM                     19:00               7:00 PM
                  8:00                8:00 AM                     20:00               8:00 PM
                  9:00                9:00 AM                     21:00               9:00 PM
              10:00                  10:00 AM                     22:00            10:00 PM
              11:00                  11:00 AM                     23:00            11:00 PM




4.    CONNECTING THE CUFF TO THE MONITOR

     Insert the cuff tubing connector into the air port in the side of the monitor.               f
     Make sure that the connector is completely inserted to avoid air leakage           /‘D _
     during blood pressure measurements.

     A Avoid compression or restriction of the connection tubing during measurement,

     which may cause inflation error, or harmful injury due to continuous cuff pressure.



5.    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 left arm 1—2em above the elbow joint.
     c.    While seated, place palm upside in front of you on a flat surface                    w j"
            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:
             ®©     Please refer to the cuff circumference range in "SPECIFICATIONS" to make
                    sure that the appropriate cuff is used.
             ©      Measure on the left arm each time.



                                                     8/16


               DN:KD-926-SMSY01 V1.0                                        Operation Guide
          Do not move your arm, body, or the monitor and do not move the rubber
           tube during measurement.
          Stay quiet, calm for 5 minutes before blood pressure measurement.
          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.


6. BODY POSTURE DURING MEASUREMENT

     Sitting Comfortably Measurement
     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 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 left arm straight along your side with your palm upside.
     c.   The cuff should be placed at the same level as your heart.


7. TAKING YOUR BLOOD PRESSURE READING

     a. After applying the cuff and your body is in a comfortable position, press the
          “START/STOP” button. 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.See picture 7-1.
     b. Then the current memory bank ( or ) is blink. See picture 7-2. Press “MEM”
        button to change over to other bank. See picture 7-3. Confirm your selection by
          pressing “START” button. The current bank can also be confirmed automatically
          after 5 seconds with no operation.




    Picture 7-1          Picture 7-2       Picture 7-3        Picture 7-4         Picture 7-5
     c.   After selecting the memory bank, the monitor starts to seek zero pressure. See
          picture 7-4.
     d. Then the cuff will be slowly inflated. The blood pressure and pulse will be
          measured during inflation. Inflation will stop as soon as the blood pressure and
          pulse rate have been calculated and displayed on the LCD. The irregular


                                            9/16


               DN:KD-926-SMSY01 V1.0                                          Operation Guide
          heartbeat symbol (if any) and blood pressure classification indicator will blink on
          the LCD. See picture 7-5. The result will automatically be stored in the Memory
          bank of the monitor.
     e. After measurement, the monitor will turn off automatically after 1 minute of no
          operation.
     f.   During measurement, you can press the “START/STOP” button to turn off the
          monitor manually.
   Note: Please consult a health care professional for interpretation of pressure measurements.


8. DISPLAYING STORED RESULTS

  a. In Clock Mode, press “MEM” button, the monitor will display sign of current group.The
     amount of results in current user memory zone will be displayed. See picture 8.Press
     “START/STOP” button to switch group, press “MEM” to confirm current group.
  b. Then LCD will display the average value of the last three results in this bank. See
     picture 8-1. If no result stored, LCD will show picture 8-2.
  c. Press “MEM” button, the LCD will display the average value of all results in the current
     user memory zone. See picture 8-3. If no result stored in the current user memory
     zone, LCD will display “0” for blood pressure and pulse rate. See picture 8-4.
  d. Press “MEM” button again, the most recent result will be displayed with date and time
     stamp. See picture 8-5. Irregular heartbeat symbol (if any) and blood pressure
     classification indicator will blink at the same time. If the monitor has no result stored in
     the current user memory zone, the LCD will display “0” for blood pressure and pulse
     rate. See picture 8-6.
  e. Press “MEM” button again to review the next result. In this way, repeatedly pressing
     the “MEM” button displays the respective results measured previously.




          Picture8               Picture 8-1             Picture 8-2             Picture 8-3




          Picture 8-4            Picture 8-5            Picture 8-6


  Note: When the monitor displaying the measurement, the classification color indicator


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                 DN:KD-926-SMSY01 V1.0                                       Operation Guide
            can be shown different color according to the systolic pressure and diastolic
            pressure. Refer to the “ASSESSING HIGH BLOOD PRESSURE FOR ADULTS”
            section.


9. SYNCHRONIZING STORED RESULTS
    a. In Clock Mode, press “MEM” button, the monitor will wait Bluetooth connect and
        Bluetooth symbol flashing after confirming the group. See picture 8-1. Bluetooth
        symbol will stop flashing when Bluetooth is connected. Send symbol flashing until
        Synchronize finished. See picture 8-3. Send symbol flashing means it is synchronizing
        the memory at this time.
    b. If an accident happens, synchronous unfinished, unfinished symbol flashing. See
        picture 8-5.
    c. When Bluetooth is disconnected, the monitor will turn off automatically after 1 minute
        of no operation. You can also press the “START/STOP” button to turn off the monitor
        manually.


10. DELETING MEASUREMENTS FROM THE MEMORY
    When any result is displaying (exclude average value displaying), keeping on pressing
    button “MEM” for three seconds, all results in the current bank will be deleted . See picture
    10. Press the button “START/STOP”, the monitor will be turned off.




                                          Picture 10

11. ASSESSING HIGH BLOOD PRESSURE FOR ADULTS
The following guideline for assessing high blood pressure (without regard to age or gender)
has 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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                  DN:KD-926-SMSY01 V1.0                                        Operation Guide




 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. 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 specified in part
SPECIFICACIONS. 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 preset 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.


13. TROUBLESHOOTING (1)
    PROBLEM                       POSSIBLE CAUSE                            SOLUTION
                        The cuff position was not correct or    Apply the cuff correctly and try
                        it was not properly tightened           again.
                                                                Review the “BODY POSTURE
                        Body posture was not correct during     DURING          MEASUREMENT”
                        testing                                 sections of the instructions and
LCD Display shows                                               re-test.
abnormal result         Speaking, arm or body movement,         Re-test when calm and without
                        angry, excited or nervous during        speaking or moving during the
                        testing                                 test.
                                                                 It is inappropriate for people with
                        Irregular heartbeat (arrhythmia)          serious arrhythmia to use this
                                                                 Electronic Sphygmomanometer.




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                DN:KD-926-SMSY01 V1.0                                     Operation Guide


14. TROUBLESHOOTING (2)
      PROBLEM                     POSSIBLE CAUSE                         SOLUTION
 LCD shows low battery                Low Battery                   Change the batteries
       symbol
   LCD shows “Er 0”          Pressure system is unstable
                                 before measurement              Don’t move and try again.
   LCD shows “Er 1”         Fail to detect systolic pressure
   LCD shows “Er 2”         Fail to detect diastolic pressure
   LCD shows “Er 3”        Pneumatic system blocked or cuff
                              is too tight during inflation      Apply the cuff correctly and
   LCD shows “Er 4”          Pneumatic system leakage or                  try again
                            cuff is too loose during inflation
   LCD shows “Er 5”         Cuff pressure above 300mmHg
   LCD shows “Er 6”          More than 3 minutes with cuff        Measure again after five
                              pressure above 15 mmHg              minutes. If the monitor is
   LCD shows “Er 7”           EEPROM accessing error                still abnormal, please
   LCD shows “Er 8”        Device parameter checking error       contact the local distributor
   LCD shows “Er A”        Pressure sensor parameter error              or the factory.
 No response when you        Incorrect operation or strong       Take out batteries for five
  press button or load       electromagnetic interference.       minutes, and then reinstall
        battery.                                                        all batteries.
                                                                 Reset iOS/Android device.
                                                                 Reset monitor. Make sure
                                 Bluetooth connection
                                                                       the monitor and
       Bluetooth               unsuccessful, monitor is
                                                                   iOS/Android device are
      connection                  abnormal, or strong
                                                                 away from other electrical
       unstable             electromagnetic interference is
                                                                   equipment. Please see
                                        present
                                                                 GENERAL SAFETY AND
                                                                      PRECAUTIONS




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                   DN:KD-926-SMSY01 V1.0                                       Operation Guide
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 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, and the cuff integrity is maintained after 1,000
     open–close cycles of the closure.
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.


EXPLANATION OF SYMBOLS ON UNIT


       Symbol for” THE OPERATION GUIDE MUST BE READ”(The sign background colour:
       blue.The sign graphical symbol: white)


         Symbol for “WARNING”


            Symbol for “TYPE BF APPLIED PARTS” (The cuff is type BF applied part)

      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 “COMPILES WITH MDD93/42/EEC REQUIREMENTS”


                       Symbol for “DATE OF MANUFACTURE”


                                                14/16


andon DN :KD—926—SMSYO1 V1.0                                               Operation Guide


                   Symbol for "EUROPEAN REPRESENTATION®

SN            Symbol for "SERIAL NUMBER*®

  j          Symbol for "KEEP DRY"



WARRANTY INFORMATION
Only charge the cost of components and transport.


SERVICE CENTER

u        ANDON HEALTH CO., LTD.
       No. 3 Jinping Street, YaAn Road, Nankai District, Tianjin 300190, China.
Tel: 86—22—60526081


                Lotus Global Co., Ltd.
               1 Four Seasons Terrace West Drayton, Middlesex, London, UB7 9GG, United
Kingdom
Tel: +0044—20—75868010       Fax: +0044—20—79006187


IMPORTANT INFORMATION REQUIRED BY THE R&TTE

This product is approved in accordance to R&TTE directive transmitter.
interference
This product complies with Industry Canada. IC: RSS—247
IC NOTICE
This device complies with Industry Canada licence—exempt RSS standard(s). Operation is sub
ject to the following two conditions:
(1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may cause undesired
operation of the device.


The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, In
c and any use of such marks by ANDON HEALTH CO., LTD. is under license.
Other trademarks and trade names are those of their respective owners.


This product is approved in accordance to R&TTE directive transmitter.
Hereby, ANDON HEALTH CO., LTD., declares that this KD—926 is in compliance with the
essential requirements and other relevant provisions of Directive 1999/5/EC. See part
Directive 1999/5/EC declaration of conformity




                                            15/16


andon onxpemstever vio                                             Operaton Guide


ELECTROMAGNETIC COMPATIBILITY INFORMATION
                                 Table 1 Emission
Phenomenon           Complance                    Electromagnetic environment
RF ontssions         oseri1
                     SapT os                       Home hoalthcare anironment
Harmonicisterton     500100022
                     ClassA                        Home healthcare anvironment
Volage fhcuatons     IEGatoooss                    Home healhcare anionmont
andfickor            Complance

                             Table 2— Enclosure Port
Phenomenon           Basic— EMC standard                Immunity test levels
                                                   Home Healthcare Environment
Eecrogac                                   Women
Dischage             Eosto042              H210, mWV, 2BV, eV oi
                                           Toum
Radiated RF EM old 120 sto0043             eovie27GHe
                                           soveAM at thide
Proimy nds tom                             Reromes
nF          wieless 1earop.aa
communications
cautpment
Rated         pors                         s0%m
reauency magnatie| Estoras                 5tz or 604
fieds

      Table 3 —— Provimity fekds from FF wireless communications equipment
 Test frequency          Band                          Immunity testlevels
       (Wia             Mn                 Professional healthcare faciity environment
aes                smas               Pulss medulaton 1ede, 2r¥m
aso                awar0              EM, <toite deviation, iz sns uim
To                 Toier              Pulss medulaton 217z a¥im
Ts
7eo
2o                 moses              Pulss modiaron fede, favim
C
se
1zo                Toxteso            Pulss modilaron »Fre, 2ov‘m
Teis
Tor0
2izo               smessro            Puls meieronsmie, soum
seo                stoosmo            Pulss modulaton 217¥sVim
Soo
sres



                                      im


                  DN:KD-926-SMSY01 V1.0                                      Operation Guide
                                           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 KD-926
The KD-926 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the KD-926 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the KD-926 as recommended below,
according to the maximum output power of the communications equipment.
 Rated maximum             Separation distance according to frequency of transmitter
       output                                             m
     power of            150 kHz to 80 MHz       80 MHz to 800 MHz       800 MHz to 2,5 GHz
    transmitter
                               d  1.2 P               d  1.2 P                d  2.3 P
            W



           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.




                                             17/16


                DN:KD-926-SMSY01 V1.0                                  Operation Guide

FCC Caution.

Any Changes or modifications not expressly approved by the party responsible for
compliance could void the user's authority to operate the equipment.

Note: 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.

The device has been evaluated to meet general RF exposure requirement. The device
can be used in portable exposure condition without restriction.




                                          18/16



Document Created: 2016-12-30 09:25:40
Document Modified: 2016-12-30 09:25:40

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