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`US 20050075542Ai
`
`(19} United States
`(12} Patent Application Publication no) Pub. No.: US 2005/0075542 A1
`
`Gnldrcich
`(43) Pub. Date:
`Apr. 7, 2005
`
`(54) SYSTEM AND METHOD FOR AUTOMATIC
`MONITORING OF THE HEALTH OF A USER
`
`Publication Clnfiificatinn
`
`Int. CL" ..................................................... i. AEIB 5,100
`{51}
`............................. 1.600f300
`(52) US. Cl.
`............ i.
`
`(57)
`
`ABSTRACT
`
`A system and method [or automatically monitoring at least
`one physiological function of the user, without active inter-
`vention by tho nscr, in a non-invasive manner. Such moni—
`toring may he used to detect a dctcrioration in the health of
`thc uscr. Prcfcrably,
`the system according to thc prcscnt
`invention features at
`[cast one physiological sensor for
`measuring the physiological parameter of the user to obtain
`the mcasurcmcot of a physiological I'urtction, a local pro-
`cessing unit
`for cxlmcting medical
`information from the
`physiological measurement. and a main server for process—
`ing the mcrlicai information in order to cvaluatc the hcalth
`of the uscr. Such an evaluation is preferably performer! by
`comparing medical information which has been obtained
`from a plurality of physiological measurements. Optionally
`and more preferably.
`the user is alertch if the evaluation
`detects a deterioration in at least one physiological function.
`
`US. Patent No. 8,923,941
`
`{76)
`
`Inventor: ani Goldrcich, ilaAyin (IS)
`
`Correspondcncc Address:
`Anthony Castorlna
`G E Ehrlich
`Suite 207
`2001 Jefferson Davis Highway
`Arlington, VA 22202 (US)
`
`Appl. No.;
`
`101433523
`
`PCT liilcd:
`
`Dec. 21, 2001
`
`PCT No:
`
`PC'I‘flLflllflllIiT
`
`Related U.S. Application Data
`
`Provisional application No. 602581142. filed on Dec,
`27, 2000.
`
`100
`
`\
`
`PROCESSING UNIT I
`marrow |
`l
`
`114
`
`127
`PROCESSED
`
`DATA
`TRANSMISSION
`LINK
`
`COMM. PORT
`115
`
`124
`
`MEASURING DEVICE
`
`STANDARD FUNCTION
`DEVICE
`
`102
`
`MEDICAL
`SERVICE
`CENTER
`
`COMMUNICATION AND
`VISUALIZING UNIT
`
`CELLULAR PHONE
`
`VOICE OR SMS
`
`MAIN SERVER
`,— ____ _ _ fl
`
`' DATABASE I
`L u _ _ _ ._ __t
`
`THEEIEEL‘T
`LPBQBLEJ
`
`WSTJKEIZ—Ih—léi
`i
`UNIT
`r
`L— 77fi_4
`
`REPORTS
`
`EXTERNAL
`SYSTEMS
`
`Apple Inc.
`APLl 043
`
`Apple Inc.
`APL1043
`U.S. Patent No. 8,923,941
`
`001
`
`FITBIT, Ex. 1043
`
`

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`FITBIT, Ex. 1043
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`

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`US 2005/0075542 A1
`
`Patent Application Publication Apr. 7, 2005 Sheet 2 of 3
`
`/102
`
`003
`
`FITBIT, Ex. 1043
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`

`

`US 2005/0075542 A1
`
`Patent Application Publication Apr. 7, 2005 Sheet 3 of 3
`
`102\\
`
`004
`
`FITBIT, Ex. 1043
`
`

`

`US 2005/0075542 A1
`
`Apr. 7, 2005
`
`005
`
`t-iowever, in the present health care system it is not
`[0005]
`possible for financial and practical reasons for a person
`specialized in treating heart disease to personally monitor
`continuously the health of a subject. Therefore, as previ-
`ously described, the subject must be examined periodically
`by medical personnel. However, periodic examinations may
`not be performed with sufficient frequency to detect a health
`problem and/or deterioration in the function of the body of
`the subject, until such deterioration has already become
`pronounced. A more efl'ective type of examination would
`therefore allow the subject to perform at least some aspects
`of the examination outside of a medical environment, with-
`out direct assistance from medical personnel, for example at
`home.
`
`is required. Thus, such measurements are not
`the user
`typically performed on a regular basis by individuals who
`are not known to be suffering from reduced cardiac function.
`
`[0007] On other hand, regular monitoring of one or more
`vital signs, for example on a daily or weekly schedule,
`without interfering with the normal habits of the subject
`andfor becoming a nuisance to the subject, is clearly helpful
`for monitoring the health condition of the subject and to alert
`the subject
`in case of deterioration in the health of the
`subject. From the health care system point of view, it is a
`method to filter the needed users from the rest of the healthy
`population, so they could receive medical treatment as soon
`as the symptoms are detected; saving hospitalization days. by
`implementing preventive medication for those needed users.
`
`SUMMARY OF THE INVENTION
`
`[0008] The background art does not teach or suggest a
`system or method for automatically monitoring the health of
`the user, without requiring active intervention by the user.
`Furthermore, the background art does not teach or suggest a
`mechanism for automatically monitoring at least one physi-
`ological function of the user. The background art also does
`not teach or suggest such a mechanism, which can be easily
`operated outside of the medical environment. Such a system
`or method would clearly be useful, as it would enable the
`health of the user to be monitored frequently,
`thereby
`enabling earlier detection of a deterioration in the health of
`the user, with the possibility of early treatment.
`
`[0009] The present invention overcomes these deficiencies
`of the background art by providing a system and method for
`automatically monitoring at least one physiological function
`of the user, without active intervention by the user,
`in a
`non-invasive manner. Such monitoring may be used to
`detect a deterioration in the health of the user. Preferably, the
`system according to the present invention features at least
`one physiological sensor for measuring at least one physi-
`ological parameter of the user. a local proCessing unit for
`extracting medical information by measuring at
`least one
`physiological
`function of the human body according to
`information obtained from the measurements, and a main
`server for processing the medical information in order to
`evaluate the health of the user. Such an evaluation is
`
`information.
`preferably performed by comparing medical
`which has been obtained from a plurality of physiological
`measurements. Optionally and more preferably, the user is
`alerted if the evaluation detects a deterioration in at least one
`physiological function.
`
`[0010] According to a preferred embodiment of the
`present invention, the physiological measurements and/or
`the obtained medical information are stored in a database.
`Optionally and more preferably. such stored data is provided
`to medical personnel who are treating the user, for example
`for more accurate diagnosis. Also optionally and more
`preferably, medical personnel receive an alert if a deteriou
`ration in one or more physiological functions is detected.
`
`[0011] Examples of physiological functions and medical
`information which may optionally be monitored by the
`present invention include, but are not limited to: heart rate,
`arrhythmia, heart rate variability, ECG, blood pressure, body
`temperature and respiration rate. As used herein, the term
`“physiological parameter" refers to a signal which is
`received from a sensor and/or medical instrument, white the
`
`SYSTEM AND METHOD FOR AUTOMATIC
`MONITORING OF THE HEALTH OFA USER
`
`FIELD 01“ 'I'llE INVEN'I'ION
`
`invention relates to a method and
`[0001] The present
`system for automatically monitoring the health of a user
`with at least one measuring device, and in particular, to such
`a system and method in which the measurements are per-
`formed automatically without the intervention of the usw
`
`DESCRIPTION OF THE BACKGROUND ART
`
`[0002] Many dilIcrent types of diseases are preventable or
`at least treatable if early detection of one or more symptoms
`or aspect of the disease is possible. Such early detection is
`currently perforated by requiring the subject
`to receive
`regular examinations by a doctor, such as an annual exami-
`nation for example. However, even annual examinations
`may not be sufficiently frequent in order to detect early signs
`of disease, yet requiring more frequent examinations could
`result in reduced compliance of the subject and increased
`cost.
`
`[0003] One example of a discern: for which more frequent
`monitoring could be useful is cardiac disease. Early detec—
`tion of symptoms of cardiac disease, such as an increase in
`blood pressure, decrease in overall cardiac function, and/or
`development of a cardiac arrhythmia for example, could
`result in earlier and more efliectivc treatment.
`
`[0004] As is well known in the background art, monitoring
`a subject for one or more symptoms of heart disease is
`primarily based on the measurement of the vital signs of the
`subject, such as heart beat, the pattern of cardiac function
`such as arrhythmia, heart rate variability, ECG measure-
`ments, blood pressure, and optionally also body temperature
`and respiration parameters, at regular intervals. These mea—
`surement(s) are performed in order to ensure that the blood
`pressure level, heartbeat rate andtor other aspects of cardiac
`function remain within the normal area.
`
`In order to perform such an examination at home,
`[0006]
`the subject would need to obtain one or more measurements.
`Currently,
`the subject needs to use a medical
`instrument,
`such as a manual or an automatic blood pressure inflating
`cutf device. Blood pressure measurements are usually per-
`formed by the home (non-mcdical) subject once a day. Such
`medical instruments are difiicult and awkward for the sub
`ject to operate, such that
`the subject compliance may be
`reduced. Furthermore, the measurements can currently only
`be performed manually, such that the active intervention of
`
`005
`
`FITBIT, Ex. 1043
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`

`

`US 2005/0075542 A1
`
`Apr. 7, 2005
`
`of a physiological parameter and/or medical information of
`the user from an expected standard causes an alert to be
`transmitted, optionally to the user, antl alternatively or
`additionally to the medical service center and/or other
`medical personnel. The expected standard may optionally be
`relative to previous measurements of physiological param-
`eters and/or previously obtained medical information. Alter-
`natively or additionally,
`the expected standard may be
`absolute, such that the measurements are beyond the normal
`expected values, such as very high or very low blood
`pressure, arrhythmia, and so forth. The alert could optionally
`be sent to the medical service center in order to make a
`decision whether the user should contact a medical doctor
`for further medical examinations. Alerting the user could
`optionally be made by any kind of communication means
`(such as a voice message by telephone andfor sending a SMS
`or other text message to the cellular telephone, or by e-mail).
`
`006
`
`term “medical information" refers to the information which
`may be extracted or otherwise obtained by analyzing this
`signal andfor a combination of signals.
`
`[0012] One or more physiological sensors for monitoring
`the user according to the present invention may optionally
`be concealed in a device, which is normally used by the user
`as part of daily life. Such a device is preferably operated by
`the user for at least one function which is not related to
`monitoring a physiological function of the uses Examples of
`such devices include, but are not
`limited to, a watch.
`bracelet, cellular telephone, regular telephone connected to
`the PSTN [public switched telephone network), furniture
`such as a chair or bed for example, keyboard, computer
`mouse, computer mouse pad, and so forth. Therefore the
`measurements are performed without the requirement for
`direct action or intervention by the user, and hence with little
`or no interference with the user’s daily life.
`
`the
`[0013] According to a preferred embodiment of
`present invention, the physiological sensor which performs
`the physiological measurement is preferably connected to a
`local data processing unit through a communication com—
`ponent. The communication component preferably features
`wireless transmission, although alternatively the connection
`may be wired.
`through a cable for example. The local
`processor is itself more preferably connected to a main
`server, optionally through a wireless communication link but
`alternatively through a wired communication link.
`
`[0014] The main server optionally and preferably features
`a database for storing the medical information and/or physi-
`ological measurements obtained from the local processor
`andfor the physiological sensor. The main server more
`preferably also features a software module for monitoring
`the user’s health by performing an algorithm to issue an alert
`whenever necessary. The algorithm operates on data stored
`in the database, preferably to create a user medical profile,
`which is optionally and more preferably based on the user’s
`medical history, medical information from external systems
`and on an average readings of physiological parameters,
`most preferably collected over an extended period of time,
`or at least collected repeatedly.
`
`implementation of the
`[0015] According to an optional
`present
`invention,
`the system further features a medical
`service center that can optionally and preferably initiate a
`medical examination in order to obtain "onvline" or “real
`time" measurements of physiological parameters regarding
`the user’s current medical status and to obtain an on-line
`report about recent and/or historical measurements. The
`medical report can also optionally and preferably be initiated
`also by the user. on-line via the Internet or other network for
`example, or off-line by any other communication means.
`Periodical reports regarding the user’s measurements results
`are optionally and preferably sent to the user and/or to the
`medical service centeri
`
`[0016] The expression "medical service center" refers in
`this connection to anyone who participates in the monitoring
`of the user and who needs to monitor the development of the
`user’s health. Therefore this person does not necessarily
`have to be a medical doctor, but should be qualified to work
`in a medical service center.
`
`the
`[0017] According to a preferred embodiment of
`present invention, any signifieantdeviation in measurements
`
`[0018] The invention also optionally and preferably
`relates to a portable measuring device with which the
`method according to the invention can be applied. The
`measuring device according to the invention is preferably
`characterized in that the measuring device features a mea-
`suring unit, an optional processing unit and a communica-
`tions device that uses a wired or a wireless data transmission
`link. The measuring unit andfor the optional processing unit
`also preferably features some type of mechanism for sup~
`plying the results via the communications device to a system
`on a main server for data storage and processing, and
`optionally also for generating alerts, such that the data is
`more preferably also available to a medical service centeri
`
`[0019] The term “wired communications device” refers in
`this connection to any device which is suitable for wired
`communications and by means of which the user can trans-
`mit his measurement results to the data processing, storing
`and alerting system on a main server. Such a communica-
`tions device may be for example any wired communication
`infrastructure, such as a PSTN, ISDN, Internet, LAN, cable
`modems and fiber-optic networks, etc.
`
`[0020] The term "wireless communications device" refers
`in this connection to any device which is suitable for
`wireless communications and by means of which the user
`can transmit his measurement results to the data processing,
`storing and alerting system on a main server, regardless of
`where the user is at the moment Such a communications
`device may be for example any radio transmitter, and/or
`mobile phone, Bluetooth device, wireless LAN, pager, etc.
`
`[0021] The term “physiological sensor” refers in this con-
`nection to any sensor. optionally with a processing unit,
`which is suitable for measuring the physiological vital signs
`of the user or any standard medical equipment (such as
`automatic blood pressure device, ECG device and so forth,
`for example), that is capable of delivering output signal(s)
`andfor processed data via a data line or wireless link to the
`system on a main server andtor to a local data processing
`unit, Non-limiting. illustrative examples of such a sensor
`include a piezoceramic transducer, a piezoelectric trans-
`ducer, a bio-impedance meter, a resistive strain gauge and a
`pressure sensor with fiber-optic components.
`
`[0022] Among the advantages of the present invention are
`optionally and preferably the constant daily/weekly sched—
`uled transmission of measurement results from the user to
`the server, the gathering of measurement results in the user’s
`
`006
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`FITBIT, Ex. 1043
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`

`

`US 2005/0075542 A1
`
`Apr. 7, 2005
`
`normal environment and the possibility for the server to
`monitor the recent development of the user’s health without
`a visit to the doctor. in which case the user can visit the
`doctor/hospital only when required and not according to a
`predetermined schedule.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0023] The foregoing and other objects, aspects and
`advantages will he better understood from the following
`detailed description of a preferred embodiment of the inven-
`tion with reference to the drawings, wherein:
`
`[0024] FIG. 1 is a schematic block diagram of an exem-
`plary but preferred implementation of the system according
`to the present invention;
`[0025] FIG. 2 shows a first exemplary implementation of
`the monitoring device according to the present invention;
`and
`
`[0026] FIG. 3 shows a second exemplary implementation
`ofthe monitoring device according to the present invention.
`
`007
`
`[0027] The present invention is of a system and method
`[or automatically monitoring at
`least one physiological
`function of the user, without active intervention by the user.
`in a non-invasive manner. Such monitoring may he used to
`detect a deterioration in the health of the user. Preferably, the
`system according to the present invention features at least
`one physiological sensor for measuring the physiological
`parameter of the user
`to obtain the measurement of a
`physiological function, a local processing unit for extracting
`medical information from the physiological measurement.
`and a main server for processing the medical information in
`order to evaluate the health of the user, Such an evaluation
`is preferably performed by comparing medical information
`which has been obtained from a plurality of physiological
`measurements. Optionally and more preferably, the user is
`alerted if the evaluation detects a deterioration in at least one
`physiological ftnction.
`
`the physiological measurement is preferably connected to a
`local data processing unit through a communication com—
`ponent. The communication component preferably features
`wireless transmission, although alternatively the connection
`may be wired,
`through a cable for example. The local
`processor is itself more preferably connected to a main
`server, optionally through a wireless connection but alter-
`natively through a wired connection.
`
`[0031] The main server optionally and preferably features
`a database for storing the medical information andfor physi-
`ological measurements obtained from the local processor.
`The main server more preferably also features a software
`module for monitoring the user’s health by performing an
`algorithm to issue an alert whenever necessary. The algo-
`rithm operates on data stored in the database, preferably to
`create a user medical profile, which is optionally and more
`preferably based on the user’s medical history, medical
`information from external systems and on an average read—
`ings of physiological parameters, most preferably collected
`over an extended period of time, or at
`least collected
`repeatedly.
`
`[0032] The principles and operation of a device and
`method according to the present invention may be better
`understood with reference to the drawings and the accom-
`panying description.
`
`’I‘urning now to the drawings, FIG. I is a block
`[0033]
`diagram ol‘the preferred embodiment of the system accord-
`ing to the invention. A system 100 features a measuring
`device 102 for measuring at least one physiological param-
`eter of the user. Measuring device 102 preferably features a
`communication module 104 and at least one physiological
`sensor 106, but more preferably features an array of physi—
`ological sensors as shown Physiological sensor 106 senses
`at
`least one physiological parameter such as heart beat,
`arrhythmia, heart rate variability, ECG, blood pressure, body
`temperature and respiration parameters for example. Addi—
`tionally or alternatively, physiological sensor 106 may also
`perform some other medically related measurement, such as
`measuring Sp02 (oxygen pressure in the blood]
`for
`example.
`
`into a
`[0034] Measuring device 102 is preferably built
`device which is frequently used by the user in everyday tasks
`such as watch, bracelet, cellular phone, telephone, chair,
`keyboard, computer’s mouse, computer’s mouse pad, bed,
`etc. This. device may he described as a standard function
`device 108. Therefore, during normal Operation ofstandard
`function device 108 by the user, direct physical contact is
`maintained with the measuring device 102, preferably with-
`out the requirement for direct intervention or action by the
`user. One or more measurements may optionally be taken by
`measuring device 102 from the user automatically through
`such direct physical contact.
`
`[0035] One optional but preferred example of measuring
`device 102 is a portable device which is preferably worn on
`the wrist of the user. For this example, standard function
`device 108 is preferably a wristwatch. According to pre—
`ferred embodiments of the present
`invention.
`the wrist-
`mounted device (measuring device 102 with standard func-
`tion device 108) features one or more sensors attached to a
`wristband or other fastening article. The scnsorfs) are pref—
`erably connected to a microprocessor, optionally by a wire
`but alternatively through a wireless connection. The micro-
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`[0028] Examples of physiological functions and medical
`information which may optionally be monitored by the
`present invention include, but are not limited lo, heart beat.
`arrhythmia, heart rate variability, ECG, blood pressure, body
`temperature and respiration parameters.
`
`[0029] One or more physiological sensors for monitoring
`the user according to the present invention may optionally
`be concealed in a device which is normally used by the user.
`Such a device is preferably operated by the user for at least
`one function which is not related to monitoring a physi-
`ological function of the user. Examples of SuCl‘t devices
`include, but are not limited to, a watch, bracelet, cellular
`telephone. regular telephone connected to the PSTN (public
`switched telephone network), furniture such as a chair or bed
`for example, keyboard, computer mouse, computer mouse
`pad, and so fonh. Therefore the measurements are per—
`formed without a direct action or intervention by the user,
`and hence with little or no interference with the user's daily
`life.
`
`the
`[0030'] According to a preferred embodiment of
`present invention, the physiological sensor which performs
`
`007
`
`FITBIT, Ex. 1043
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`

`

`US 2005/0075542 A1
`
`Apr. 7, 2005
`
`008
`
`the data is
`[0042] Once receiva by main server 112,
`preferably first added to a database 118. Once a plurality of
`such measurements of physiological parameters and/or
`medical
`information has been collected, main server 112
`preferably executes an algorithm to create a medical profile
`120 for the uses Medical prolile 120 optionally and more
`preferably also incorporates information gathered from
`external medical server and databases. Examples of such
`information include but are not
`limited to the medical
`history of the user and medical information from an external
`system 122. External system 122 may optionally be a
`different medical instrument or database, for example hos-
`pital records stored in a database. Additionally or alterna-
`tively, medical profile 120 preferably includes information
`obtained by combining average readings of physiological
`parameters, and more preferably includes their divergence.
`collected over an extended period of time by measuring
`device 102.
`
`processor may optionally also be located within the wrist-
`band, or otherwise attached to the wristband The scnsor(s)
`preferably suppon automatic collection of at
`least one
`physiological measurement; more preferably, the micropro-
`cessor is able to execute one or more instructions for
`
`extracting clinically useful information about the user from
`such measurement(s).
`
`[0036] The microprocessor more preferably operates a
`software program to process and analyze the data which is
`collected,
`in order to compute medical information. The
`extracted medical information, optionally also with the raw
`data.
`is
`then preferably transferred to the previously
`described communication module. This module then pref-
`erably relays such information to a main server, which more
`preferably is able to provide such information to medical
`personnel, for example as part of a medical service center.
`Therefore, continuous monitoring of
`the physiological
`parameters of the user may optionally and more preferably
`be made, enabling better medical care for the user.
`
`[0037] A general, non-limiting example of suitable formu—
`lae for measuring the heart rate andror other heart-related
`physiological parameters of a subject who is wearing the
`device according to the present invention may be found in
`the article “Cuffdcss Continuous Monitoring of Beat—To—
`Beat Blood Pressure Using Sensor Fusion“, by Boo-Ito
`Yang, Yi Zhang and 11. Harry Asada—IEEE (also available
`through
`http:i/web.mitedujayi/wwwjpdf/
`IEEETransZUOUpdf as of Dec. 9, 2001). hereby incorpo—
`rated by reference as if fully set forth herein, where systolic
`and diastolic blood pressure are calculated using the pulse
`pressure shape per heartbeat. The disclosure does not
`describe a device which has the functionality according to
`the present invention, but the disclosed method is generally
`useful
`for determining blood pressure from an external
`measurement of pressure from the pulse through the skin of
`the subject.
`
`[0033] After the measurement has been performed, corn-
`munication module 104 preferably transmits the measure—
`ment result to a local data processing unit 110. Communi-
`cation module 104 may optionally be a wired or wireless
`communication such as serial communication port (using
`serial protocols such as R8232, [Rda or USB) or "Blue-
`tooth” communication controller. Communication module
`
`104 then preferably transmits the measurement result sup-
`plied by physiological sensor 106, for example in the form
`of a data packets, to local processing unit 110. A similar
`communication module 127 also performs communication
`at
`local processing unit 110, and is of a corresponding,
`compatible type to the type of communication module 104.
`Local data processing unit 110 may also optionally be
`incorporated within standard Function device 108 as shown,
`or alternatively may be incorporated in a separate device
`(not shown). Measuring device 102 and local data process-
`ing unit 110 can therefore optionally and preferably be
`combined in a single enclosure, whether as part ofstandard
`function device 108 or otherwise, thereby creating a stand-
`alone medical device, which includes both measuring and
`processing functions.
`
`[0039] The transmitted data is optionally and preferably
`sent, additionally or alternatively, directly to a main server
`112. According to an optional embodiment, one or both of
`communication module 104 (if the measured data of physi-
`
`otogicai sensor 106 is transmitted directly to main server
`112, as described in greater detail below) or communication
`module 127 may optionally be implemented as a mobile unit
`(such as a cellular telephone) which transmits the measure-
`ment result supplied by physiological sensor 106, optionally
`using the telephone as a cellular modern {i.e. sending data in
`the form of cellular data packets) or alternatively in form of
`a Short Message Service (SMS) message, or any other
`suitable format.
`
`[0040] For the preferred embodiment in which local data
`processing unit 110 receives the data, local data processing
`unit 110 preferably first decodes the message to extract the
`sensor data. Local data processing unit 110 then preferably
`executes an algorithm to extract medical information, such
`as heart beat rate, arrhythmia, heart rate variability and/or
`divergence of the pattern of heartbeats over a period of lime.
`calculating the blood pressure from a blood pulse pressure
`sensor andfor calculating the respiration rate for example, or
`any combination thereof. As previously described, prefcr~
`ably an algorithm is taken from the article “Cuff-less Con-
`tinuous Monitoring of Beat-'I'o-Beat Blood Pressure Using
`Sensor Fusion”, by Boo—Ho Yang, Yi Zhang and H. Harry
`Asada—IEEE (also available through htlpiffwebmiledu/
`zyifwwwipdfilEEE’Iranslflflflpdf as of Dec. 9, 2001), pre-
`viously incorporated by reference.
`
`local data processing unit 110 optionally and pref—
`[0041]
`erably stores the sensor data and the calculated results in a
`memory 114. More preferably, local data processing unit 110
`stores the data and calculated results at
`least until
`this
`information is to be transmitted to main server 112 through
`a communication module 127.
`
`[0043] The operation ol‘the algorithm by main server 112
`preferably enables any alteration, change or deterioration in
`the physiological function of the user to be determined, by
`comparing recent measurements of one or more physiologi—
`cal parameters with infonnation taken from medical profile
`120. Optional but preferred examples of comparisons which
`could be performed include but are not limited to detecting
`any increase in average readings of systolic blood pressure
`over time in comparison to average recent readings of
`systolic blood pressure, and/or any alteration in average
`heart rate, especially outside the normal range. Optionally
`and more preferably, such a determination of an alteration,
`change or deterioration in the condition of the user causes
`
`008
`
`FITBIT, Ex. 1043
`
`

`

`009
`
`Personnel at medical service center 126 may
`[0048]
`optionally and preferably check the measurements using a
`visualization module 128 (such as a PC (personal computer)
`or a computer workstation with a screen to view the
`retrieved information as graphs andlor text, for example).
`Medical service center 126 can initiate a medical examina
`tion in order to obtain on-line physiological data regarding
`the physiological parameters of the user who is in physical
`contact with measuring device 102. Medical service center
`126 can optionally receive such on-line data by first receiv-
`ing an on-line message from the measuring device 102 that
`the user is currently in direct physical contact with measur-
`ing device 102. Next, then the medical service center 126
`can optionally and preferably command measuring device
`102 to take a measurement, and more preferably can receive
`the results immediately after finishing the examinations.
`
`user. Alternatively or additionally. such a check may option-
`ally bc manually initiated also by the user (for example by
`pressing on a start button while in direct contact with
`measuring device 102).
`
`[0051] Periodical reports regarding these measurements
`results are optionally and preferably sent to the user andr'or
`to medical service center 126. Also additionally or alterna-
`tively, reports may be received on—line. for example through
`the Internet, or "oil-line” through any suitable communica-
`tion mechanism.
`
`[0052] Main servot‘ database 118 preferably contains, [or
`each user, the results of the measurements, performed with
`measuring device 102 of the user andfor alternatively per-
`formed at the hospital (or other medical environment). The
`results are preferably stored in database 118, and are more
`preferably stored for an extended period of time, such as
`several years for example. l'iurtherrncrre, the medical history
`of the user, as collected from exlemal system 122, preferably
`is also available in database 118. Therefore,
`the doctor
`treating the user can optionally and preferably monitor the
`development of the user's health according to previous
`measurements. for example by using trend analysis even
`when the doctor and the user have not been in direct physical
`contact.
`
`If required, the user may also transmit additional or
`[0053]
`alternative information, other than (or in addition to) the
`measurement result and the time of measurement from local
`processing unit 110. Thus, for example if local processing
`unit 110 is a computer, the user can chat (using a keyboar