NOKIA TECHNOLOGIES (France) XNAWPM02 BloodPressure Monitor User Manual

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NOKIA TECHNOLOGIES (France) XNAWPM02 BloodPressure Monitor User Manual | Manualzz

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)  

 

 

 

  

                    

    

 

     

Requirements

 

IP22   Ingress   of   water   or   particulate   matter  

 

FCC   ID   :   XNAWPM02  

     

 

     2013

  

US   Importer   :   Withings   Inc.

  

16192   Coastal   Highway   Lewes   DE   19

EU   REPRESENTATIVE  

 

Kahl   Handelsvertretung  

Add.:   Isarstr.33

  40699   Erkrath,   Germany  

Tel:   +49   21   0447   754  

Withings   SAS   

20   bis   rue   Rouget   de   Lisle   

92130   Issy ‐ les ‐ Moulineaux  

2

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)  

             

 

 

 

Package   content  

 Withings   Blood   Pressure   Monitor  

 Four   AAA   alkaline   (LR3)   cells   (already   inserted)  

Micro ‐ USB   to   USB   adapter  

User   manual  

 

 

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.

 

3

 

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  

4

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  

 

  5

 

 

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.

  

 

 

6

 

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  

7

 

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)  

8

 

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.

 

 

9

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.

  

11

 

 

 

 

Withings Blood Pressure Monitor User’s Guide

 

Error

 

Messages

 

 

Error   message  

Measurement   could   not   be   performed.

  Please   try   again.

  If   the   problem   occurs   again,   please   contact   customer   service.

 

Connection   error.

  Quit   the   application   and   reconnect   your   blood   pressure   monitor.

  

Causes  

Hardware   auto ‐ check   error.

 

Communication   error   between   the   Blood   Pressure   Monitor   and   the   collateral   device.

 

Please   wait   until   the   cuff   is   totally   deflated   before   starting   a   new   measurement.

  Stay   still   during   measurement.

 

Check   that   the   Blood   Pressure  

Monitor   is   correctly   positioned   on   your   arm   and   that   measurement   is   performed   in   good   conditions.

 

Low   battery   level.

  Unplug   the  

Blood   Pressure   Monitor.

 

Replace   the   alkaline   cells.

 

‐  Cuff   is   not   deflated   before   measurement.

 

‐  Noise   interference.

 

‐  Excessive   user   movements.

 

‐  User   movement,   or   not   relaxed,   or   talking   …  

‐  Cuff   is   not   correctly   fastened  

‐  Cuff   broken  

‐  Pump   or   valve   failure  

‐  Pressure   overflow  

‐  Noise   interference  

‐  User   movement,   or   not   relaxed,   or   talking   …  

‐  User   special   characteristics  

‐  Battery   level   is   too   low  

Battery   level   is   too   low.

 

Countermeasure  

1 ‐  Measurement   could   not   be   performed.

  Please   try   again.

  If   the   problem   occurs   again,   please   contact   customer   service.

 

1 ‐  Push   the   blood   pressure   monitor   button   for   3   seconds   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.

 

1 ‐  Please   wait   until   the   cuff   is   totally   deflated   before   starting   a   new   measurement.

  Stay   still   during   measurement.

 

2 ‐  If   the   problem   occurs   again,   please   contact   customer   service.

 

1 ‐  Check   that   the   Blood  

Pressure   Monitor   is   correctly   positioned   on   your   arm   and   that   measurement   is   performed   in   good   conditions.

 

2 ‐  Low   battery   level.

  Unplug   the   Blood   Pressure   Monitor.

 

Replace   the   alkaline   cells.

 

3 ‐  If   user   has   special   characteristics,   please   contact   your   physician.

 

4 ‐  If   the   problem   occurs   again,   please   contact   customer   service.

 

1 ‐  Low   battery   level.

  Unplug   the   Blood   Pressure   Monitor.

 

Replace   the   alkaline   cells.

 

2 ‐  If   the   problem   occurs   again,   please   contact   customer   service.

 

 

12

 

Withings Blood Pressure Monitor User’s Guide

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Troubleshooting

 

Problem  

Though   the   batteries   are   installed,   there   is   nothing   happening   when   connected   to   iOS   or  

Android   device  

The

The

The

 

 

  inflation pressure low application result  

 

  blood  

 

  action cannot battery  

  pressure shows  

  rise icon

  cannot an

 

 

  is   cannot error

 

 

  be shown be

 

 

  done in   the taken message

 

 

 

  or   the   air   application and or  

  the   wrong  

 

 

Under   normal   measuring   circumstance,   the   reading   at   home   is   different   from   that   of   the   clinics   or   each   measurement   has   various   reading

Remedy  

1.

Check   that   your   iOS   or   Android   device   is   unlocked   

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  

1.

Check   the   cuff   position   and   fasten   the   cuff   correctly   ad   re ‐ measure   the   pressure  

  again   

2.

Check   the   blood   pressure   monitor   connection   to   the   iOS   device  

 

Replace   the   old   alkaline   cells   by   four   new   AAA   alkaline   cells.

 

1.

Re ‐ fasten   the   cuff   

2.

Relax   yourself   and   sit   down  

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  

1.

The   variation   is   due   to   the   different   environments  

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  

13

 

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     

‐ 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   environment   in   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  

CISPR11  

RE   emissions  

CISPR11  

Group   1  

 

Class   B  

The   BP ‐ 801   Wireless   Blood   Pressure   Monitor   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.

 

Harmonic   emissions  

IEC   61000 ‐ 3 ‐ 2  

Voltage   fluctuations/  

Flicker   emissions  

IEC   61000 ‐ 3 ‐ 3  

Not   applicable  

Not   applicable   

The   BP ‐ 801   Wireless   Blood   Pressure   Monitor   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.

 

15

 

 

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 ‐ electromagnetic   immunity  

Declaration   –   electromagnetic   immunity  

The   Wireless   Blood   Pressure   Monitor   system   is   intended   for   use   in   the   electromagnetic   environment   specified   below.

  The   customer   or   the   user   of   the   Wireless   Blood   Pressure   Monitor   system   should   assure   that   it   is   used   in   such   an   environment.

 

Immunity test  

  IEC  

60601 test  

 

Compl iance   level  

Electromagnetic   environment guidance  

 ‐  level  

The   Wireless   Blood   Pressure   Monitor   system   is   intended   for   use   in   the   electromagnetic   environment   specified   below.

 

The   customer   or   the   user   of   the   Wireless   Blood   Pressure   Monitor   system   should   assure   that   it   is   used   in   such   an   environment.

 

Immunity   test  

Electrostatic   discharge  

(ESD)IEC  

61000 ‐ 4 ‐ 2  

IEC  

60601   test   level

6   kV   contact  

8   kV   air  

Compli ance   level  

6   kV   contact  

8   kV   air  

Electromagnetic   environment  ‐  guidance  

Floors   should   be   wood,   concrete   or   ceramic   tile.

 

  If   floors   are   covered   with   synthetic   material,   the   relative   humidity   should   be   at   least   30  

%.

 

Conducted  

RFIEC  

61000 ‐ 4 ‐ 6  

3   Vrms  

150   kHz   to   80  

MHz  

N/A   Electrical   fast   transient/burst  

IEC   61000 ‐ 4 ‐ 4  

2   kV   for   power   supply   lines  

1   kV   for   input/output   lines  

N/A   Mains   power   quality   should   be   that   of   a   typical   commercial   or   hospital   environment.

 

Radiated  

RF  

IEC   61000 ‐

4 ‐ 3  

3   V/m  

80   MHz   to   2.5

 

GHz  

N/A  

Portable   and   mobile   RF   communication s   equipment   should   be   used   no   closer   to   any   part   of   the  

EQUIPMENT   or  

SYSTEM   including   cables,   than   the   recommended   separation   distance   calculated   from   the   equation   applicable   to   the   frequency   of   the   transmitter.

 

Interference   may   occur   in   the   vicinity   of   equipment   marked   with   the   following   sym   bol.

 

Surge  

IEC   61000 ‐ 4 ‐ 5  

Voltage   dips,   short   interruptions   and   voltage   variations   on   power   supply   input   lines  

IEC   61000 ‐ 4 ‐ 11  

Power   frequency  

(50/60   Hz)   magnetic   field  

IEC   61000 ‐ 4 ‐ 8  

1   kV   differential   mode  

2   kV   common   mode  

‐ 5   %   UT(95   %   dip   in   UT)   for  

0.5

  cycle  

‐ 40   %   UT(60  

%   dip   in   UT)   for   5   cycles  

‐ 70   %   UT(30  

%   dip   in   UT)   for   25   cycles  

‐ 5   %   UT(95   %   dip   in   UT)   for  

5   sec  

3   A/m  

N/A  

N/A  

N/A  

Mains   power   quality   should   be   that   of   a   typical   commercial   or   hospital   environment.

 

Mains   power   quality   should   be   that   of   a   typical   commercial   or   hospital   environment.

 

If   the   user   of   the   EQUIPMENT   or   SYSTEM   requires   continued   operation   during   power   mains   interruptions,   it   is   recommended   that   the   EQUIPMENT   or   SYSTEM   be   powered   from   an   uninterruptible   power   supply   or   a   battery.

 

Power   frequency   magnetic   fields   should   be   at   levels   characteristic   of   a   typical   location   in   a   typical   commercial   or   hospital   environment.

 

 

16

 

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  

 

17

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.

 

18

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