Users Manual

FCC ID: XNAWPM02

Users Manual

Download: PDF
FCCID_2072130

              Withings
Blood Pressure Monitor
                 Version 2.0
                 AUG. 2013


                                                                       Withings Blood Pressure Monitor User’s Guide



Withings is the trademark of this product and all other trademarks or Website mentioned in this
document are the properties of their respective owners.
Disclaimer
Information in this guide may change without notice. The manufacturer assumes no responsibilities
for errors that may appear in this guide.
Reference to Standards
This device complies with the following normative documents :
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices as amended by Directive 2007/47/EC
* EN ISO 13485:2003 /AC: 2009:Medical devices ‐ Quality management systems – Requirements for regulatory
  purposes (ISO 13485:2003) Reference to standards contd.
* EN ISO14971:2012: Medical devices ‐ Application of risk management to medical devices (ISO 14971:2007,
  Corrected version 2007‐10‐01)
* IEC60601‐1: 2005 + CORR. 1 (2006) + CORR. 2 (2007); EN 60601‐1:2006+AC (2010) :
  Medical electrical equipment ‐ Part 1:General requirements for basic safety and essential Performance
* EN1060‐3:1997+A1:2005+A2:2009: Non‐invasive sphygmomanometers,Part 3: Supplementary requirements
  for electromechanical blood pressure measuring systems
* EN1060‐4: 2004 Non‐invasive sphygmomanometers. Test procedures to determine the overall system
 accuracy of automated non‐invasive sphygmomanometers.
*IEC/EN 60601‐1‐11 : General requirements for basic safety and essential performance –Collateral Standard:
 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare
 environment
*IEC 80601‐2‐30: 2009 (First Edition) for use in conjunction with IEC 60601‐1:2005
 EN 80601‐2‐30: 2010/ ANSI/AAMI 80601‐2‐30: 2009 : Particular requirements for the basic safety and
 essential performance of automated non‐invasive sphygmomanometers
*EN300328 V1.8.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission
 systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation
 techniques; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
*EN301489‐1‐3 V1.9.2 (2011 ) Electromagnetic compatibility and Radio spectrum Matters (ERM);
 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements
*EN301489‐1‐17 V2.2.1(2012) Electromagnetic compatibility and Radio spectrum Matters (ERM);
 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;
 Part 1: Common technical requirements
*EN60601‐1‐2: 2007 CISPR: 2011: Medical electrical equipment: Part 1‐2: General requirements for basic
 safety and essential performance‐collateral standard electromagnetic compatibility
*EN 55011:2009/A1:2010 : Industrial, scientific and medical equipment ‐ Radio‐frequency disturbance
 characteristics ‐ Limits and methods of measurement
*FCC part B 15B: 2013 Electromagnetic Compatibility
 FCC Rule Part: 15.247 Cat: DSS (Bluetooth) FCC Rule Part: 15.247 Cat: DTS (BT4.0)
*EN ISO 10993‐1:2009 Biological evaluation of medical devices‐Part 1: Evaluation and testing within
 a risk management process (ISO 10993‐1:2009)
* ANSI/AAMI SP10: 2002/A1 2003(R) 2008: Manual, electronic or automated sphygmomanometers
* ANSI/AAMI/ISO 81060‐2:2009 Non‐invasive sphygmomanometers Part 2: Clinical validation of automated
 measurement type




              Type BF Applied Part (cuff)

                                                                   2013
                                                           US Importer : Withings Inc.
                                                           16192 Coastal Highway Lewes DE 19
                                                                                  EU REPRESENTATIVE

                                                           Kahl Handelsvertretung
                                                           Add.: Isarstr.33 40699 Erkrath, Germany
        WEEE
Requirements                                               Tel: +49 21 0447 754
  IP22 Ingress of water or particulate                     Withings SAS
  matter                                                   20 bis rue Rouget de Lisle
  FCC ID : XNAWPM02                                        92130 Issy‐les‐Moulineaux


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                                                                Withings Blood Pressure Monitor User‘s Guide



In order to use your Withings Blood Pressure Monitor, you need an iPhone, iPad, iPod touch (iOS 5
and higher) or Android (v2.3.3 and higher)



                        ‘                Made for

                        BP               Gipod (liPhone CiPad
Package content
         +   Withings Blood Pressure Monitor
         &   Four AAA alkaline (LR3) cells (already inserted)
         *   Micro—USB to USB adapter
         &   User manual




                                                                                  Systolic blood pressure
                                                                                  Dlastalic blood pressure
  Cult             —]                                                             Heart rate
                                                                                  Start/stop button


                                                                     ~——————Connector



                                                  es belien conet




                                       Micro—USB to USB adapter




Important Safety Information

Consult your doctor during pregnancy, arrhythmia and arteriosclerosis. Please read this section
carefully before using the blood pressure monitor.


                                                             Withings Blood Pressure Monitor User’s Guide



Intended use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult
patient population with arm circumference ranging from 9 inches to 17 inches (22cm‐ 42cm). This
device is not intended to be a diagnostic device. Contact your physician if hypertensive values are
indicated.

General safety and precautions

        Do not forcibly bend the arm cuff
        Do not inflate the arm cuff when it is not wrapped around your arm
        Do not apply strong shocks and vibrations to the blood pressure monitor or drop it
        Do not take measurement after bathing, drinking alcohol, smoking, exercising or eating.
        Do not immerse the arm cuff in water



          Caution

General usage

Always consult your doctor. Self‐diagnosis of measurement results and self treatment are dangerous
People with severe blood flow problems, or blood disorders, should consult a doctor before using the
blood pressure monitor. Cuff inflation can cause internal bleeding. Operational factors such as
common arrhythmias, ventricular premature beats, atrial fibrillation, arterial sclerosis, poor
perfusion, diabetes, age, pregnancy, pre‐eclampsia or renal disease can affect the performance of
the automated sphygmomanometer and/or its blood pressure reading. This device is a precision
measuring equipment liable to be understood by lay user but it still should be handled with care. A
long exposure of the device to lint, dust or sunlight might reduce its life time or damage it. Damaged
cuff or sensor might lead to incorrect measurements.

•       Do not leave the blood pressure monitor unattended with infants or persons who cannot
        express their consent.
•       Do not use the blood pressure monitor for any purpose other than measuring blood pressure.
•       Do not disassemble the blood pressure monitor.
•       Do not operate the blood pressure monitor in a moving vehicle (car, airplane)
•       Do not use a cellular phone near the deivce. It may result in an operational failure.
•       Improper continuous pressure of cuff or too frequent measurements may interfere blood flow
        and result harmful injury to the users.
•       Do not apply the cuff over the users’ arm bearing a wound or medical treatment and so on, as
        this can cause further influcence on the therapy.
AAA alkaline cells usage
•       If AAA alkaline cells fluid should get in your eyes, immediately rinse with plenty of clean water
        and cousult a doctor immediately.
•       Use only four AAA alkaline cells with this blood pressure monitor. Do not use any other types
        of AAA alkaline cells.
•       Do not insert AAA alkaline cells with their polarities incorrectly aligned.
•       Replace old AAA alkaline cells with new ones immediately. Replace all four AAA alkaline cells at
        the same time.
•       Do not use new and used AAA alkaline cells together




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                                                                                        Withings Blood Pressure Monitor User’s Guide



Table of contents
About Blood Pressure ..................................................................................................................... 6
Installation .......................................................................................................................................... 7
Begin to measure, take and store a reading ............................................................................ 9
After Use ........................................................................................................................................... 11
Error Messages ............................................................................................................................... 12
Troubleshooting ............................................................................................................................ 13
FCC Statement ................................................................................................................................. 14




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                                                            Withings Blood Pressure Monitor User’s Guide



About Blood Pressure
What is blood pressure ?

Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels, and
is one of the principal vital signs. During each heartbeat, BP varies between a maximum (systolic) and
a minimum (diastolic) pressure. The mean BP, due to pumping by the heart and resistance to flow in
blood vessels, decreases as the circulating blood moves away from the heart through arteries.

For more informations about blood pressure, please consult our website :

www.withings.com/bloodpressure

How to measure your blood pressure correctly
Before taking a reading, you should sit still for around 10 minutes,
and you should wait 1 minute between each reading.
While taking a measurement, remain sitted and stay
calm and relaxed. You should also try not to talk.
This should improve the accuracy of readings.
It is recommended to always measure your
blood pressure on the same arm.

Correct posture
Rest your arm on a table and relax your arm.

Correct cuff placement
Put the cuff around your arm
with the tube positioned on the inner side of your arm,
around 2cm above the elbow. Wrap the arm cuff snugly.
The metal sheet must be aligned with the arterial vein
when wrapping the cuff on the arm.
Correct level
Make sure the cuff is at the same level than your heart.
If you can not place your arm at the same level than
your heart, use a cushion. Your arm should lightly
bend while taking the measurement.




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                                                           Withings Blood Pressure Monitor User’s Guide



Installation
Alkaline cells are already insterted in your Withings Blood Pressure Monitor when you buy it.

Replacing the « AAA » alkaline cells

If the low battery symbol appears in the Withings application, replace all four AAA alkaline cells at
the same time.
     1. Remove the AAA alkaline cells cover at the lower end of the aluminum tube.
     2. Install or replace four AAA alkaline cells so that the + (positive) and – (negative) polarities
           match the polarities indicated on the AAA alkaline cells compartment.
     3. Put the AAA alkaline cells cover back in place. If the device will not be used for a long period
           of time, it is advised to remove the alkaline cells.


First use
Use your blood pressure monitor wirelessly on iOS
   1. Press the button on top of the blood pressure monitor to turn it on
   2. On your iOS device, go to « Settings », enter the « Bluetooth » section and turn Bluetooth on
   3. In the devices list, choose Withings BPM
   4. The device status will change to « connected » and a pop‐up will bring you to the Withings
       application on the App Store
   5. Download the Withings Health Mate application for the App Store and open it

Use your blood pressure monitor wirelessly on Android
   1. Press the button on top of the blood pressure monitor to turn it on
   2. On your Android device, go to « Settings », enter the « Bluetooth » section and turn
       Bluetooth on
   3. In the devices list, choose Withings BPM
   4. The device status will change to « connected »
   5. Download the Withings Health Mate application for the Play Store and open it

Use your blood pressure monitor with your smartphone cable on iOS
   1. Plug the smartphone USB adpater provided with your blood pressure monitor to it
   2. Plug your smartphone cable to the adapter and your iOS device
   3. Press the button on top of the blood pressure monitor to turn it on
   4. A pop‐up will ask you to download the Withings Health Mate application on the App Store
   5. Download the Withings Health Mate application for the App Store and open it

Use your blood pressure monitor with your smartphone cable on Android
   1. Plug the smartphone USB adpater provided with your blood pressure monitor to it
   2. Plug your smartphone cable to the adapter and your Android device
   3. Press the button on top of the blood pressure monitor to turn it on
   4. Download the Withings Health Mate application for the App Store and open it




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                                                          Withings Blood Pressure Monitor User’s Guide



How to Measure your blood pressure
Wirelessly on iOS
   1. Unlock your iOS device
   2. Press the button on top of the blood pressure monitor to turn it on
   3. After a few seconds, the Withings Health Mate application will open
   4. Navigate through the quickstart instructions by touching « next » until you reach the
       measurement screen (fig. 1)


Wirelessly on Android
   1. Unlock your Android device
   2. Press the button on top of the blood pressure monitor to turn it on
   3. After a few seconds, the Withings Health Mate application will open
   4. Navigate through the quickstart instructions by touching « next » until you reach the
       measurement screen (fig. 1)


Using your cable on iOS
    1. Unlock your iOS device
    2. Press the button on top of the blood pressure monitor to turn it on
    3. After a few seconds, the Withings Health Mate application will open
    4. Navigate through the quickstart instructions by touching « next » until you reach the
       measurement screen (fig. 1)

Using your cable on Android
    1. Unlock your Android device
    2. Press the button on top of the blood pressure monitor to turn it on
    3. After a few seconds, the Withings Health Mate application will open
    4. Navigate through the quickstart instructions by touching « next » until you reach the
       measurement screen (fig. 1)




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                                                          Withings Blood Pressure Monitor User’s Guide



Begin to measure, take and store a reading
    1. On the measurement screen (fig. 1), touch the «start» button to launch the measurement.
The blood pressure monitor is designed to take measurements and store the measurement values in
the memory of the device (iPhone, iPad or iPod Touch).




                                          Fig. 1
Using the single mode
•     On the measurement screen (fig. 1) press the «Start» button. The cuff starts to inflate
      automatically. As the cuff inflates, the blood pressure monitor automatically determines your
      ideal inflation level. This blood pressure monitor detects the pulse during inflation. Do not
      move your arm and remain still until the entire measurement process is completed.

Note : To stop the inflation or measurement, touch «Stop» button or push the device on top of the
tube. The blood pressure monitor will stop inflating and start deflating.

•     Inflation stops and the measurement is stopped. As the cuff deflates, the heartbeat symbol
      flashes at every heartbeat.
•     When the measurement is complete, the arm cuff completely deflates. Your blood pressure
      and pulse rate are displayed.
•     Press «OK » to see your results in advanced mode. Rotate your device to display your graphs.

Note : Self‐diagnosis of measured results and treatment are dangerous. Please follow the instructions
of your doctor.




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                                                             Withings Blood Pressure Monitor User’s Guide



Using the auto mode
The auto mode will take three measurements separated by an interval of time in order to calculate a
precise average of your blood pressure.
•     On the measurement screen (fig. 2), touch the preferences icon . Make certain the auto mode
      is enabled. Select the interval,between each measurement.
•     Press the « Start » button. The cuff starts to inflate automatically. As the cuff inflates (fig. 6),
      the blood pressure monitor automatically determines your ideal inflation level. This blood
      pressure monitor detects the pulse during inflation. Do not move your arm and remain still
      until the entire measurement process is completed.

Note : To stop the inflation or measurement, press and release the « Stop » button. The blood
pressure monitor will stop inflating and start deflating.

•     Inflation stops and the measurement is started. As the cuff deflates, the heartbeat symbol
      flashes at every heartbeat.
•     When the measurement is complete, the arm cuff completely deflates.
•     After the selected interval, a second and a third measurement will start.
•     Your average blood pressure is displayed.
•     Press « OK » at the end of a measurement to see your results in advanced mode. Rotate your
      device to display your graphs.

Notes
•     The three individual measurement results are not displayed while auto mode is taking the
      measurements.
•     Self‐diagnosis of measured results and treatment are dangerous. Please follow the in‐
      structions of your doctor.
•     You will have to activate the auto mode each time you want to use it.




                                                  Fig. 2
                                                                                                       10


                                                           Withings Blood Pressure Monitor User’s Guide



After Use

Cleaning

       Do not use an alcoholic‐base or solvent agent to clean the device.
       Clean the device with a soft, dry cloth.
       The dirt on the cuff can be cleaned by a moisten cloth and soap .
       Do not flush the device and cuff with much water
       Do not dismantle the device or disconnect the cuff or try to repair by yourself. If any problem
        happens, refer to the distributor.
       Do not operate the device under severe environment of extreme temperature or humidity,
        or direct sunshine.
       Do not shake the unit violently.
       Do not submerge the device or any of the components in water.
       Do not let the device under strong shocks, such as dropping the unit on the floor

Storage

    If you are not using the device for an extended period, remove the alkaline cells from the
     aluminium tube for storage.
    Store the device and the components in a clean, safe location



Maintenance

If you can’t fix the problems using the troubleshooting instructions , request service from your dealer.
Manufacturer will make available on requested circuit diagrams, component part lists, descriptions,
calibration instructions, or other information that will assist manufacturer’s staff or authorized
representative for repair. It is generally recommended to have the device inspected every 2 years, to
ensure proper functioning and accuracy.




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                                                               Withings Blood Pressure Monitor User’s Guide



Error Messages
Error message                      Causes                                Countermeasure
Measurement could not be           Hardware auto‐check error.            1‐ Measurement could not be
performed. Please try again. If                                          performed. Please try again. If
the problem occurs again,                                                the problem occurs again,
please contact customer                                                  please contact customer
service.                                                                 service.
Connection error. Quit the         Communication error between           1‐ Push the blood pressure
application and reconnect your     the Blood Pressure Monitor            monitor button for 3 seconds
blood pressure monitor.            and the collateral device.            to turn it off. Quit the
                                                                         application and push the blood
                                                                         pressure monitor button to
                                                                         turn it on.
                                                                         2‐ If the problem occurs again,
                                                                         please contact customer
                                                                         service.
Please wait until the cuff is      ‐ Cuff is not deflated before         1‐ Please wait until the cuff is
totally deflated before starting   measurement.                          totally deflated before starting
a new measurement. Stay still      ‐ Noise interference.                 a new measurement. Stay still
during measurement.                ‐ Excessive user movements.           during measurement.
                                                                         2‐ If the problem occurs again,
                                                                         please contact customer
                                                                         service.
Check that the Blood Pressure      ‐ User movement, or not               1‐ Check that the Blood
Monitor is correctly positioned    relaxed, or talking …                 Pressure Monitor is correctly
on your arm and that               ‐ Cuff is not correctly fastened      positioned on your arm and
measurement is performed in        ‐ Cuff broken                         that measurement is
good conditions.                   ‐ Pump or valve failure               performed in good conditions.
                                   ‐ Pressure overflow                   2‐ Low battery level. Unplug
                                   ‐ Noise interference                  the Blood Pressure Monitor.
                                   ‐ User movement, or not               Replace the alkaline cells.
                                   relaxed, or talking …                 3‐ If user has special
                                   ‐ User special characteristics        characteristics, please contact
                                   ‐ Battery level is too low            your physician.
                                                                         4‐ If the problem occurs again,
                                                                         please contact customer
                                                                         service.
Low battery level. Unplug the      Battery level is too low.             1‐ Low battery level. Unplug
Blood Pressure Monitor.                                                  the Blood Pressure Monitor.
Replace the alkaline cells.                                              Replace the alkaline cells.
                                                                         2‐ If the problem occurs again,
                                                                         please contact customer
                                                                         service.




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                                                         Withings Blood Pressure Monitor User’s Guide



Troubleshooting
Problem                                            Remedy
Though the batteries are installed, there is       1.  Check that your iOS or Android device is
nothing happening when connected to iOS or             unlocked
Android device                                     2.  Check and correct the AAA alkaline cells
                                                       polarities
                                                   3.  Remove the AAA alkaline cells and wait for
                                                       one minute. Then install the AAA alkaline
                                                       cells back.
                                                   4.  Replace the AAA alkaline cells

The inflation action cannot be done or the air     1.    Check the cuff position and fasten the cuff
pressure cannot rise                                     correctly ad re‐measure the pressure
                                                         again
                                                   2.    Check the blood pressure monitor
                                                         connection to the iOS device

The low battery icon is shown in the application   Replace the old alkaline cells by four new AAA
                                                   alkaline cells.

The blood pressure cannot be taken and the         1.    Re‐fasten the cuff
application shows an error message or wrong        2.    Relax yourself and sit down
result                                             3.    Keep the cuff and heart at the same level
                                                         during the measurement period
                                                   4.    Keep silent and still during measurement
                                                   5.    If the patient has sever heart beat
                                                         problem, then the blood pressure may not
                                                         be read correctly

Under normal measuring circumstance, the           1. The variation is due to the different
reading at home is different from that of the          environments
clinics or each measurement has various reading    2. The blood pressure is changing according to
                                                       the physiological or psychological status of
                                                       the human body
                                                   3. Show your recorded values to your physician




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                                                          Withings Blood Pressure Monitor User’s Guide



FCC Statement
Federal Communications Commission (FCC) Statement 15.21
You are cautioned that changes or modifications not expressly approved by the part responsible for
compliance could void the user’s authority to operate the equipment.

15.105(b)
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.
This device complies with Part 15 of the FCC Rules.Operation is subject to 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 of the device.

FCC RF Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment. End users must follow the specific operating instructions for satisfying RF exposure
compliance. This transmitter must not be co‐located or operating in conjunction with any other
antenna or transmitter.
This device complies with Industry Canada license‐exempt RSS standard(s). Operation is subject 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.




                                                                                                     14


                                                            Withings Blood Pressure Monitor User‘s Guide



RF Statement
—Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and
 put into service according to the EMC information provided in the following.

—Interference may occur in the vicinity of equipment marked with  A
                                                                    ((tg)
—Portable and mobile RF communication equipment (e.g. cell phones) can affect Medical Electrical
Equipment.
—The use of accessories and cables other than those specified may result in increased emissions or
decreased immunity.
—~The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and
 are not likely to cause any interference in nearby electronic equipment.
~The device is suitable for use in all establishments, including domestic establishments and those
 directly connected to the public low voltage power supply network that supplies buildings used for
 domestic purposes.
—Portable and mobile RF communications equipment should be used no closer to any part of the
 device, including cables, than the recommended separation distance calculated from the equation
 applicable to the frequency of the transmitter.
~The device is intended for use in an electromagnetic environmentin which radiated RF disturbances
 are controlled. Any other accessories, transducers and cables may result in increased emissions or
 decreased immunity and EMC performance.
~The device should not be used adjacent to or stacked with other equipment and that if adjacent or
 stacked use is necessary, which should be observed to verify normal operation in the configuration
 in which it will be used.

Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC information provided in the following. Portable and mobile RF
communication equipment (e.g. cell phones) can affect Medical Electrical Equipment. The use of
accessories and cables other than those specified may result in increased emissions or decreased
immunity of the unit.

      Guidance and manufacturer‘s declaration—electromagnetic emissions
  The Wireless Blood Pressure Monitor is intended for use in the electromagnetic environment
  specified below. The customer or the user of the Wireless Blood Pressure Monitor should assure
  that it is used in such an environment.
  Emissions test       Compliance            Electromagnetic environment— guidance

  CE emissions         Group 1               The BP—801 Wireless Blood Pressure Monitor uses RF
  CISPR11                                    energy only for its internal function.
                                             Therefore, its RF emissions are very low and are not
  RE emissions         Class B               likely to cause any interference in
  CISPRIL                                    nearby electronic equipment.

  Harmonic
  emissions            Not applicable        The BP—801 Wireless Blood Pressure Monitor is suitable
  IEC 61000—3—2                              for use in all establishments, including domestic
                                             establishments and those directly connected to the
  Voltage                                    public low—voltage power
  fluctuations/                              supply network that supplies buildings used for
  Flicker emissions    NO# applicable        domestic purposes.
  IEC 61000—3—3




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                                                                             Withings Blood Pressure Monitor User’s Guide




 Declaration – electromagnetic emissions and immunity for equipment and
   systems that are not life‐supporting and are specified for use only in a
                              shielded location
The Wireless Blood Pressure Monitor declaration‐                        Declaration – electromagnetic immunity
           electromagnetic immunity
  The Wireless Blood Pressure Monitor system is       The Wireless Blood Pressure Monitor system is intended for use in
      intended for use in the electromagnetic                 the electromagnetic environment specified below.
  environment specified below. The customer or        The customer or the user of the Wireless Blood Pressure Monitor
 the user of the Wireless Blood Pressure Monitor         system should assure that it is used in such an environment.
  system should assure that it is used in such an
                   environment.
Immunity         IEC      Compl Electromagnetic      Immunity              IEC            Compli     Electromagnetic environment ‐
    test       60601       iance    environment ‐      test              60601             ance                guidance
                 test       level     guidance                          test level         level
                level                                 Electrostatic     6 kV contact        6 kV     Floors should be wood,
                                                       discharge           8 kV air       contact
                                                        (ESD)IEC                          8 kV air   concrete or ceramic tile.
                                                       61000‐4‐2                                      If floors are covered with
                                                                                                     synthetic material, the relative
                                                                                                     humidity should be at least 30
                                                                                                     %.

Conducted    3 Vrms      N/A       Portable and       Electrical fast      2 kV for        N/A       Mains power quality should be
                                                     transient/burst    power supply
  RFIEC      150 kHz                  mobile RF       IEC 61000‐4‐4          lines                   that of a
61000‐4‐6     to 80              communication                             1 kV for                  typical commercial or hospital
                                                                        input/output
              MHz                   s equipment                              lines                   environment.
                                 should be used
                                 no closer to any        Surge               1 kV          N/A       Mains power quality should be
                                                     IEC 61000‐4‐5       differential
                                     part of the                            mode                     that of a typical commercial or
                                 EQUIPMENT or                           2 kV common                  hospital environment.
                                                                            mode
                                       SYSTEM
                                      including
 Radiated     3 V/m      N/A                          Voltage dips,     ‐5 % UT(95 %       N/A       Mains power quality should be
                                 cables, than the          short         dip in UT) for
    RF       80 MHz               recommended         interruptions        0.5 cycle                 that of a
IEC 61000‐    to 2.5                                   and voltage       ‐40 % UT(60                 typical commercial or hospital
                                     separation       variations on       % dip in UT)
    4‐3        GHz                     distance       power supply        for 5 cycles               environment.
                                                        input lines      ‐70 % UT(30                 If the user of the EQUIPMENT
                                 calculated from     IEC 61000‐4‐11       % dip in UT)
                                   the equation                          for 25 cycles               or SYSTEM
                                                                        ‐5 % UT(95 %                 requires continued operation
                                   applicable to                         dip in UT) for
                                  the frequency                               5 sec                  during power
                                        of the                                                       mains interruptions, it is
                                    transmitter.                                                     recommended that
                                    Interference                                                     the EQUIPMENT or SYSTEM be
                                   may occur in                                                      powered
                                   the vicinity of                                                   from an uninterruptible power
                                     equipment                                                       supply or a
                                    marked with                                                      battery.
                                   the following
                                                         Power             3 A/m           N/A          Power frequency magnetic
                                         sym           frequency
                                         bol.          (50/60 Hz)                                           fields should be at
                                                     magnetic field                                  levels characteristic of a typical
                                                     IEC 61000‐4‐8
                                                                                                                location in a
                                                                                                      typical commercial or hospital
                                                                                                               environment.




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                                                            Withings Blood Pressure Monitor User’s Guide



DISPOSAL
Actuation of European directives 2002/95/EC, 2002/96/EC and 2003/108/EC, for
reduction in use of dangerous substances in the electric and electronic device and
for garbage disposal. The symbol applied on the device or its packaging means that
at the end of its useful life the product must not be disposed of with domestic waste.
At the end of devices useful life, the user must deliver it to the able collecting
centers for electric and electronic garbage, or give back to the retailer when
purchasing a new device. Disposing of the product separately prevents possible
negative consequences for the environment and for health, deriving from
inadequate disposal. It also allows the recovery of materials of which it’s made up in
order to obtain an important saving of energy and resources and to avoid negative
effects to the environment and health. In case of abusive disposal of device by the
user, will be applied administrative endorsements in compliance with current
standard. The device and its parts is mared with regard to disposal, as appropriate, in
accordance with national or regional regulations.




Specifications
Technical data

Product description: Digital automatic Blood Pressure Monitor
Model: BP‐801 (Withings)
Measurement method: Cuff oscillometric method
Cuff inflation: Automatic inflation with air pump at 15 mmHg/s
Pressure sensor: Gauge sensor
Measurement range(pressure): 0 to 285 mmHg
Measurement range (pulse): 40 to 180 beats/min
Accuracy (pressure): Within +‐ 3 mmHg or 2% of reading
Accuracy (pulse): Within +‐5% of reading
Sensor: Semiconductor pressure sensor
Operating conditions: 10 to 40°C, 15 to 90% RH, atmospheric 86Kpa~106kpa, altitude: 2000m
Storage and transport conditions: ‐25 to 70°C,10 to 95%RH,atmospheric 86Kpa~106kpa,altitude: 2000m
Arm type: Circumference 22‐42cm (9”‐17”)
Dimensions: 150(L) x 140(W) x 100(H)
Power source: AAA alkaline cells (x4)
Weight: Approx. 600g without cells
Accessories: AAA Alkaline cells x4, Micro‐USB to USB adapter, Instruction manual
Product life : 5 years
Wireless transmission V4.0 dual mode (V2.1 + EDR)
Note : Specifications are subject to change without prior notice or any obligation on the
parts of the manufacturer




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                 Withings Blood Pressure Monitor User’s Guide




                           User manual v2.0‐ Aug., 2013
                    © 2013 Withings. All rights reserved.
iPad, iPhone and iPod touch are trademarks of Apple inc.




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Document Created: 2019-07-08 20:56:37
Document Modified: 2019-07-08 20:56:37

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