User manual

FCC ID: 2ABG7-DB68

Users Manual

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FCCID_4233902

Blood Pressure Monitor




                               Model:DB68




                              User Manual


                                                            Rev.00
                                                         2019/03/14


Thank you for purchasing TRULY Blood Pressure Monitor. Please read

through this "User’s Manual" before using the product.




                                    1 / 15


                                               Contents



1. Identification For Use         ----------------------------------------------------------3
2. Safety Precautions           -----------------------------------------------------------3
3. Quick start Guide
   3.1    Monitor               -------------------------------------------------------------5
   3.2   Battery Installation     ----------------------------------------------------------6
4. Taking Measurement
   4.1 Sitting Correctly        ------------------------------------------------------------6
   4.2 Applying the Arm Cuff        --------------------------------------------------------7
   4.3 Taking measurement          ---------------------------------------------------------7
   4.4 Heartbeat Readings         ----------------------------------------------------------7
5. Memory Functions
   5.1 View Past Readings ----------------------------------------------------------8
   5.2 Delete Past Readings         --------------------------------------------------------8
6. Troubleshooting               -----------------------------------------------------------8
7. Storage & Maintenance         ------------------------------------------------------------9
8. Product Specifications       ------------------------------------------------------------9
9. EMC Declaration              ------------------------------------------------------------10

10.   Disposal                ------------------------------------------------------------14

11.FCC Statement                ------------------------------------------------------------14




                                                    2 / 15


1. Identification For use
Truly Automatic Arm Blood Pressure Monitor intended to measure the systolic and
diastolic blood pressure 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 devices’ features include irregular pulse rhythm detection during measurement, and
will display a alert signal with the reading when irregular heartbeat is detected.
The devices’ feature include Bluetooth function to transmit data to an external Bluetooth
device with wireless communication .
The devices are intended to use of Over-The-Counter

2. Safety Precautions
Caution
The monitor uses the oscillometric method to measure systolic and diastolic blood
pressure, as well as heart rate 。
- This device is intended for use in measuring blood pressure and pulse rate in the
    adult population, do not use this device on infants or persons who cannot express
    their intentions: The monitor is not intended to be a diagnostic device, It is a home
    healthcare product only and it is not intended to serve as a substitute for the advice of
    a physician or medical professional。
- Don't not use this device for diagnosis or treatment of any health problem or disease,
    Measurement results are for reference only, consult a healthcare professional for
    interpretation of pressure measurements, Contact your physician if you have or
    suspect any medical problem. Do not change your medications without the advice of
    your physician or healthcare professional。
- Use only Truly authorized parts and accessories Parts and accessories not approved
    for use with the device may damage the unit and get a error of measurement。There
    are no replaceable parts (such as sensors, electrode pads, etc.). Do not disassemble
    or repair or modify the ME EQUIPMENT, it will get a error of measurement If you need
    to repair, please contact the dealer and repair it.
- Proper cuff size is critical for accurate measurements ,Follow the instructions in this
    manual and printed on the arm cuff to ensure the appropriate size of cuff is being
    used。
- Blood pressure measurement can be affected by the other factors; Position of the
    user such as bending over the body or cross-legged sitting will produce abdominal
    pressure or make the position of the arm below the heart, that will increase the blood
    pressure。
    „ This product is not suitable for people with arrhythmias or serious arteriosclerosis.
        It may have difficulty determining the proper blood pressure for pregnant women
        and for users with irregular heartbeat, diabetes, pre-eclampsia, poor circulation of
        blood, measurement on the arm on the side of a mastectomy,kidney problems or
        for users who have suffered from a stroke;
- When measurement, The pressurization of the cuff to arm where intravascular access
    or the rapy,or an arterio-venous(A-V) shunt,is present because of temporary
    interference to blood flow and could result in injury to the patient;
                                            3 / 15


-   When measurement, The pressurization of the cuff can temporarily cause function of
    simultaneously used monitoring other device on the same limb;
-   The pulse display is not suitable for checking the frequency of heart pacemakers;
-   Do not use a cellular phone near the device, It may result In an operational failure;
-   Do not use the monitor in the driving or flying vehicles;
-   Frequenly measuring will make the blood not flow, cause the arm-numbness and
    abnormal reaction of body。

When you are using the monitor to measure especially frequently used, the arm is
compressed by the cuff, and then the fingertip will be caused congestion. During the
congestion, please loosen the cuff and lift the hands over your head, and make your right
and left hand squeese and stretch 15 times, them will unclog the congestion;
Do not applying the CUFF over a wound, as this can cause further injury;
- When measurement, please check that operation of the device does not result in
   prolonged impairment of the circulation of the blood of the patient;
- Do not compress the cuff tube during the measurement, or it will cause fail inflation or
   affect the result of measurement;
- Please use the product in the approved operate environment, the time required for the
   ME EQUIPMENT to warm from the minimum storage temperature is two hours;the
   time required for the ME EQUIPMENT to cool from the maximum storage temperature
   is two hours;or will cause the inaccurate result of Handling batteries properly:
   measurement;
- Handling batteries properly: measurement
   „ As soon as old batteries run out, replace with newbatteries,
   „ Do not use old and new batteries together
   „ Align the polarities of batteries correctly;
   „ When the unit will not be used for more than 3 months,remove the
         batteries,Ohterwise, batteries may leak and cause damage to the unit。
- Dispose of the device,components and optional ,accessories according to applicable
   local regulation,Unlawful disposal may cause environmental pollution。
- Don’t calling around the Blood pressure monitor when it is using ,Don’t move and
   avokd electromagnetic interference and noise interference when measuring that to
   avoid to measure error。
- When the screen display the battery for one degree,it means that low Voltage and
   must change the new one to void to measure error。
- Babies, young children or individuals who cannot express their consent are not
   suitable to take blood pressure measurement.
- Keep the equipment away from children and pets.
- Blood pressure readings may change in case of pregnancy. Pregnant women can
   consult their doctor before taking measurement。
- Individuals with serious arteriosclerosis are not suitable to take blood pressure
   measurement。
- Self-measurement is not medical treatment lf there are unusual values, please
   consult your doctor。

                                           4 / 15


¾ Hand
     dling batteries properrly
  „ lithium-lon batteries are
                          a subjectt to disposa   al and Reccycling regulations that vary by
     c
     country annd region.AAlways che  eck and fo ollow your applicable e regulations before
     d
     disposing  o any batte
                of         ery contacct recharge eable battery recycling corporattion。
  „ Do
     D not disa assemble,C Crush,or puncture a battery.
  „ Do
     D not sho ort the exte
                          ernal contacts on a ba  attery.
  „ Do
     D not disp pose of a battery
                          b       in fiire or wate
                                                 er.
  „ Keep
     K     the battery
               b       awaay from chiildren.
  „ Do
     D not use e a damage  ed battery.


3. Quic
      ck Start Guide
               G

Attention:Don't disassem
                d         ble,repairr and reno
                                             ovation ontology。
Connectt AC Adap
               ptor (optio
                         onal)




a.    If you havee the AC adaptor,Plu
                            a        ug it into the AC addaptor jacck at the top
                                                                             t   of the
      deevice.Remove batterries when using
                                     u     the AC
                                               A adaptorr.
b. Pllug the AC  C adaptor in
                            nto a DC6V
                                     V/1000mA outlet.
Adapter: Input:100-240Va.c. 0.35A;;Output: 6.0Vd
                                               d.c. 1.0A

3.1 Monitor

Featuress
z One touch ope  eration
z Backklight and large size LCD
                            L
z 99 To otal Memoory
z Bluetooth 4.0
z Averraging mod   de-the ave
                            erage valu
                                     ue of
   the last
        l    3 meaasurementts stored in the
   memmory will dissplay
z Auto o –off powe
                 er saving fe
                            eature
z Operrated by 4 AA batteriees

Display




                                            5 / 15


Package
      e Contents
               s




3.2 Batttery Insta  allation
1 Pull and
         a lift on the
                     t lock to remove th  he battery cover.
                                                     c
2 Remo   ove the ussed batterie es and inse
                                          ert new batteries
into the battery
         b        com
                    mpartmentt an shown  n,taking carre
that the polarities(+
         p          +) and (-) match
                               m      the polarities
                                          p
of the ba
        attery comp  partment as
                               a indicatedd.
3 Repla  ace the ba attery coverr.
   Press it lightly until
                     u          ock securrely clicks into place
                           the lo                             e.


Note:Re
      eplace battteries whe
                          en the batttery indicator                 shows low voltage.
--Avoid smoking
        s        ,
                 ,eating  or exercising for 30 minutes
                                               m       be
                                                        efore takin
                                                                  ng measurrement.
-- Do not move orr talk durin
                            ng measurrement.
-- Measu
       urement can be take  en on eith
                                     her arm.



4   Taking meas
              suremen
                    nt
4.1 Sittting Correectly
1 Relaxx
2 Sit up
       pright in a chair with your both feet
                                           f   on the e floor.
3 Remo ove tight fitting clothing from yo ou upper arm
    and thick cloth
                  hing .Do no ot roll up yo
                                          our sleeve if it is too tight。
                                                                  t
4 Placee your arm on a table  e so that thhe cuff will be at the
    sam
      me level as your heartt.
                                               6 / 15


4.2 Applying the   e Arm Cufff
1 Place  e your elbo
                   ow on a tabble and palm facing upward,and
                                                     u          d wrap the arm cuff around
                                                                                        a       the
upper lefft arm.
2 Pull ono the end d of the cufff until it wraps
                                           w     securely around d your upp  per arm.Do  o not over
tighten th
         he cuff .Allow 1~2 cmm or ½ incch between    n the botto
                                                                om of the ccuff and yo   our elbow
joint.
3 Make   e sure the cuff
                    c is at thhe same le   evel as you
                                                     ur heart.
Note:
--Proper cuff size is critical for accura   ate measu urements.FFollow the instructions is this
manual and
         a printed d on the arrm cuff to ensure
                                            e      the appropriatte size of ccuff is being used.
--This monitor
        m         co
                   omes with  h a stand     dard size arm cufff that fitss arms 8.7″~13.4″
                                                                                        8
(22cm~   ~34cm).
--Position
         n cuff edgee 0.4~0.8 inches(1~2    2cm)abovee elbow.

4.3 Tak  king Meassurement
1 Presss the “⊙”b button.the cuff
                             c will auttomatically
                                                 y inflate and the meassurement will w start.
2 When the measurementt is comp        plete,the cuff will au  utomaticallyy deflate and your
systolic and
         a diastollic pressurre values and
                                       a pulse rate
                                                 r     will dissplay.
3 Remo   ove the arm
                   m cuff and take note of your meeasuremen     nt results.

4.4 Hearrtbeat Rea
                 adings




                                               7 / 15


5 . Mem
      mory Fun
             nctions

After meeasuremen  nt,the last set of measured values
                                                    v        will be savedd automaticcally after
measure ement when the unit is i turned off
                                         o by press sing “⊙”bu  utton or by automatic power off
after 3 minutes.
        m
5.1 Vie ew Past Re eadings
1 Presss the “MEM  M”button too enter memory functtion,
2 Presss the “MEM  M”button too display thhe next setts of valuees.Past reaadings are displayed
from the most rece ent to the oldest.
                              o
3 This can
         c stored  d up to 99 sets
                               s    of passt readings
                                                    s.
5.2 Dellete Past Readings
                    R
When the monitor’’s power iss off,press and hold the memo       ory button”MEM”for 5 seconds
until the
        e memory icon “ⓜ”appears in the display .Witthout rele            easing the memory
button,prress the po
                   ower button“⊙” and “EE EE” will  w appear.R   Release thhe power button
                                                                                     b      “⊙”
and the memory
         m          button.”MEEM” to erasse all store
                                                    ed readingss from the monitor.


6. Troubleshoo
             oting
Problem                Cau
                         use                              Solution
No display when you Havve the batte  eries run out?
                                                 o        Replace nnew batteries.
press the
        e Power /S
                 Start
                       Are the batteryy polarities
                                                 s wrong? Re-align batteries in correct
button
                                              8 / 15


                                                            polarities.
“Er P” displayed         Fail to inflate                    Check if the cuff is properly
                                                            connected.Replace the air
                                                            tube if it is broken.
“Er 1” displayed         Deflate too rapidly                Return for servicing.
“Er 2” displayed         Movement during measurement        Do      not      move  during
                                                            measurement
                         Signal interference                Remove interfering source
                                                            e,g. mobile phones,magnets.
“Er 3” displayed         Incorrect results                  Measure again

Note: If your problem cannot be solved by the above,consult your store of
purchase.Do not disassemble the unit.



7. Storage & Maintenance
— Keep away the unit from direct sunlight,extreme temperatures,humidity or moisture.
— Use a dry,soft cloth to clean the unit,or if desired,use a cloth lightly dampened with
  water.
— Do not use alcohol,benzene,thinner or other volatile liquids to clean the unit.
— Do not wash or expose the arm cuff to liquid.
— The user must check that the equipment functions safely and see that it is in proper
  working condition before being used.

WARNING: long power cable and air hose.To avoid strangulation and
entanglement,keep cable and hoses out of reach of young children.



8. Product Specifications
Model No.                           DB68
Measurement method                  Oscillometric
Measurement range                   Pressure:20~280 mmHg
                                    Pulse Rate:40~195 beats/min
Accuracy                            Pressure: ±3 mmHg     Pulse Rate: ±5%

Inflation                           Pump driven

Pressure Detection                  Semi-conductor

Power Supply                        4x AA batteries


                                             9 / 15


   Auto power off                                3 minute after not being used

   The pressure of the running                   70KPa~106KPa

   Storage Environment.                          -20℃~60℃,10%~95%RH

   Operating       Environment.                  10℃~40℃,30%~85%RH

   Dimensions                                    124×95×52mm

   Net Weight                                    236g ( batteries excluded)
   Used Life Span of Battery                     1000 times
   Software version
   Use Period                                    5 year
   Application part                              Out of contact the body,:onnect tub、shell
                                                 contact the body :cuff
   Cuff Dimensions                               For arm circumference of 22~34cm(Special size to be
                                                 ordered separately)
   Package Content                               Cuff ,Instruction Manual,Battery Set ,Warrant Card


   Note:Subject to modification without prior notice.




   9. EMC Declaration
                    Guidance and manufacturer’s declaration – electromagnetic immunity
The XXX” is intended for use in the electromagnetic environment specified below. The customer
or the user of the “XXX” should ensure that it is used in such an environment.
                                IEC 60601                 Compliance               Electromagnetic environment –
   Immunity test
                                 test level                 level                            guidance
Electrostatic           ±6 kV contact              ±6 kV contact               Floors should be wood, concrete or
                                                                               ceramic tile. If floors are covered with
discharge (ESD)         ±8 kV air                  ±8 kV air                   synthetic material, the relative humidity
IEC 61000-4-2                                                                  should be at least 30 %.


Electrical fast         ±2 kV for power            ±2 kV for power             Mains power quality should be that of a
transient/burst                                                                typical commercial or hospital
                        supply lines               supply lines
                                                                               environment.
IEC 61000-4-4           ±1 kV for input/output     ±1 kV for input/output
                        lines                      lines


Surge                   ±1 kV differential         ±1 kV differential          Mains power quality should be that of a
                                                                               typical commercial or hospital
IEC 61000-4-5           mode                       mode
                                                                               environment.
                        ±2 kV common mode          ±2 kV common mode



                                                           10 / 15


Voltage dips, short       <5 % UT                    <5 % UT                Mains power quality should be that of a
interruptions and         (>95 % dip in UT)          (>95 % dip in UT)      typical commercial or hospital
                          for 0,5 cycle              for 0,5 cycle          environment. If the user of the
voltage variations
                                                                            “XXX” requires
on power supply           40 % UT                    40 % UT                continued operation during power
input lines               (60 % dip in UT)           (60 % dip in UT)       mains interruptions, it is recommended
                          for 5 cycles               for 5 cycles
IEC 61000-4-11                                                              that the “XXX” be
                          70 % UT                    70 % UT                powered from an uninterruptible power
                          (30 % dip in UT)           (30 % dip in UT)       supply or a battery.
                          for 25 cycles              for 25 cycles

                          <5 % UT                    <5 % UT
                          (>95 % dip in UT)          (>95 % dip in UT)
                          for 5 sec                  for 5 sec


Power frequency           3 A/m                      3 A/m                  Power frequency magnetic fields
(50/60 Hz)                                                                  should be at levels characteristic of a
                                                                            typical location in a typical commercial
magnetic field
                                                                            or hospital environment.
IEC 61000-4-8



NOTE UT is the a.c. mains voltage prior to application of the test level.




                                                              11 / 15


EMC Declaration                    (Continued)
               Guidance and manufacturer’s declaration – electromagnetic immunity
 The “XXX” is intended for use in the electromagnetic environment specified below. The customer or
 the user of the “XXX” should ensure that it is used in such an environment.
                     IEC 60601 test        Compliance
 Immunity test                                                   Electromagnetic environment – guidance
                           level             level
                                                             Portable and mobile RF communications
                                                             equipment
                                                             should be used no closer to any part of the
                                                             “XXX”, including cables, than the
                                                             recommended separation distance calculated from
                                                             the equation applicable to the frequency of the
                                                             transmitter.
                                                             Recommended separation distance

                   3 Vrms                                    d=1.2√P
 Conducted RF
                   150 kHz to 80 MHz            3V
 IEC 61000-4-6                                               d=1.2√P      80MHz to 800MHz

                                                             d=2.3 √P     800MHz to 2.5 GHz

 Radiated RF       3 V/m
                                               3 V/m
 IEC 61000-4-3     80 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 metres (m).
                                                             Field strengths from fixed RF transmitters, as
                                                             determined
                                                                                                a
                                                             by an electromagnetic site survey, should be
                                                             less than the compliance level in each frequency
                                                             range.b
                                                             Interference may occur in the vicinity of equipment
                                                             marked with the following symbol:




 NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
 NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
 absorption
 and reflection from structures, objects and people.

     Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
 a   land
     mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
     theoretically
     with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
     electromagnetic site
     survey should be considered. If the measured field strength in the location in which the “XXX” is
     used exceeds the applicable RF compliance level above, the Medical XXX should be observed to verify
     normal operation. If abnormal performance is observed, additional measures may be necessary, such as
 b   reorienting or relocating the “XXX”.

     Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.




                                                       12 / 15


EMC Declaration
              Guidance and manufacturer’s declaration – electromagnetic emissions

   The “XXX” is intended for use in the electromagnetic environment specified below. The
   customer or the user of the “XXX” should ensure that it is used in such an environment.

      Emissions test             Compliance                 Electromagnetic environment – guidance

                                                     The “XXX” uses RF energy only for its
   RF emissions                                      internal function. Therefore, its RF emissions are very
                                   Group 1
   CISPR 11                                          low and are not likely to cause any interference in
                                                     nearby electronic equipment.

   RF emissions
                                   Class B
   CISPR 11                                          The “XXX” is suitable for use in all
   Harmonic emissions              Class A           establishments, including domestic establishments and
                                                     those directly connected to the public low-voltage
   IEC 61000-3-2                                     power supply network that supplies buildings used for
   Voltage fluctuations/                             domestic purposes.
                                   Complies
   flicker emissions
   IEC 61000-3-3




                          Recommended separation distances between
             portable and mobile RF communications equipment and the Medical XXX
   The “XXX” is intended for use in an electromagnetic environment in which radiated RF disturbances
   are controlled. The customer or the user of the Medical XXX can help prevent electromagnetic interference
   by maintaining a minimum distance between portable and mobile RF communications equipment
   (transmitters) and the
   “XXX” as recommended below, according to the maximum output power of the communications
   equipment.
                                        Separation distance according to frequency of transmitter
                                                                     m
   Rated maximum output
    power of transmitter         150 kHz to 80 MHz           80 MHz to 800 MHz           800 MHz to 2,5 GHz
             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 estimated 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.




                                                      13 / 15


11. Disposal
At the end of its use don't dispose the appliance, including removable parts and
Accessories, together with the other urban waste, but conformably to 2002/96/EC. Since
to be treated apart from home waste, you must take it to a differential collection centre
specific for electric and electronic equipment. Otherwise you can give it back to the
retailer as you buy an equivalent apparatus. There will be Server sanctions in case of
transgression。
The batteries used in this device must be disposed of in the special bins at the end of their
life。


12. FCC Statement
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates 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.
This device complies with Part 15 of FCC Rules. Operation is subject the following two
conditions:
(1) This device may not cause harmful interference, and (2)This device must accept any
    interference received, including interference that may cause undesired operation.
Information to user:
    Any Changes or modifications not expressly approved by the party responsible for
    compliance could void the user's authority to operate the equipment.




  Note: The manufacturer is not responsible for any radio or TV interference caused
  by unauthorized modifications to this equipment such modifications could void the
  user's authority, to operate this equipment.



                                            14 / 15


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Document Created: 2019-03-20 13:59:17
Document Modified: 2019-03-20 13:59:17

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