`

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`U.S. Patent
`
`Nov. 16, 2004
`
`Sheet 2 of 10
`
`US 6,820,057 Bl
`
`CardioView
`rB
`lvU:il
`file Recording Qptions Help
`I i I tt411 &l I 'ii' I~ I!'-' m ~-! Pt ii~ 1 rl Rim Vi~30sec IUGain Xl.O 11
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`
`Difference
`QRSdul'lltion:
`STdev:
`nT interval:
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`AV RR:
`X-S Div/sec (25mnv'OJ Y-2 Div/mV (IOmm/mVJ
`
`nme:
`
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`
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`
`Fig. 2
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`Fitbit, Inc. v. Philips North America LLC
`IPR2020-00828
`
`Fitbit, Inc. Ex. 1017 Page 0003
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`U.S. Patent
`
`Nov. 16, 2004
`
`Sheet 4 of 10
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`US 6,820,057 Bl
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`USER REQUEST
`FOR ANALYSIS
`
`SUPPLEMENTARY
`DATA AVAILABLE?
`
`I
`NO
`i
`
`DISPLAY DATA
`
`I
`
`l
`YES
`!
`
`DISPLAY DATA &
`SUPPLEMENTARY
`DATA
`I
`
`~ WAVEFORM
`
`MARKING
`APPLIED?
`
`I
`YES
`i
`
`ANALYSE
`WAVEFORM&
`DISPLAY
`RESULTS
`
`Fig. 3B
`
`Fitbit, Inc. v. Philips North America LLC
`IPR2020-00828
`
`Fitbit, Inc. Ex. 1017 Page 0005
`
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`U.S. Patent
`
`Nov. 16, 2004
`
`Sheet 10 of 10
`
`US 6,820,057 Bl
`
`Block Type 2 (Biolog/Paceview Single Lead)
`Data Type
`Parameter
`Data length
`unsigned int.
`Block Type
`unsigned char.
`Sampling Interval (us)
`unsigned int.
`Device Serial Number
`unsigned int.
`Device Hardware Version
`unsigned char.
`unsigned char.
`Device Software Version
`Device Type
`3 bits
`Filter Frequency
`1 bit
`Pacing Detection
`1 bit
`Pacing Detected
`1bit
`Reserved
`2 bits
`unsigned char.
`Event Date - Day
`Event Date - Month ·
`unsigned char.
`unsigned char.
`Event Date - Year
`unsigned char.
`Event Time - Hour
`unsigned char.
`Event Time - Minute
`Lead ID (Rhythm strip/SL)
`unsigned char.
`unsigned char.
`Gain Scale
`unsigned char.
`TT Scaling
`unsigned int.
`Length of record (samples)
`
`Examnle
`17 (25 for Simultaneous 12 Lead)
`2
`3333
`1234
`eg. 22 for V2A
`eg. 24 for V2.4
`O=Biolog, 1=Paceview
`O=SOHz, 1=60Hz
`O=Disabled, 1=Enabled
`O=None Detected, 1=Detected
`
`BCD
`BCD
`BCD
`BCD
`BCD
`1...12=1...V6, O=Single Lead
`units permV
`Hz permV
`Max.=65535
`
`Extension for 6 digit Serial ~umbers:
`! unsigned char.
`
`!Device Serial Number (high byte)
`
`Extension for Simultaneous 12 Lead Cable data:
`
`Device Serial Number (Cable)
`Device Hardware Version (Cable)
`Device Software Version (Cable)
`Resolution (nV)
`
`unsigned 24 bit
`unsign_ed char.
`unsigned char.
`unsigned int.
`
`123456
`eg. 11 for V1A
`eg. 10 for V1 .0
`nV per unit
`
`Fig. 9
`
`Fitbit, Inc. v. Philips North America LLC
`IPR2020-00828
`
`Fitbit, Inc. Ex. 1017 Page 0011
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`US 6,820,057 Bl
`
`1
`TELEMEDICINE SYSTEM
`
`INTRODUCTION
`
`The present invention relates to a telemedicine system
`and, more particularly, but not exclusively, to a system and
`component parts thereof adapted to acquire, record, transmit
`and analyse or have analysed ECG data and like patient data.
`
`10
`
`2
`Preferably said patient data is encoded for transmission in
`a first format whilst said supplementary data is encoded for
`transmission in a second format.
`Preferably a unique identifier is given to each said patient
`5 data storage and analysis apparatus.
`Preferably said unique identifier is embedded in a soft(cid:173)
`ware portion comprising part of said patient data storage and
`analysis apparatus.
`Preferably said patient data storage and analysis apparatus
`includes a personal computer arranged to execute a patient
`data storage and analysis program.
`Preferably said patient data storage and analysis program
`includes customisable/user manipulable data base elements.
`Preferably said patient data is encoded for transmission in
`a first format whilst said supplementary data is encoded for
`15 transmission in a second format.
`Preferably said supplementary data comprises patient data
`and/or patient data acquisition apparatus identification data.
`In a particular preferred form said patient data is ECG
`data.
`In a further broad form of the invention there is provided
`a system for communication of patient data from a patient
`location to a remote storage and analysis location; said
`system including means for transmitting said patient data on
`a predetermined signal encoded according to a predeter-
`25 mined protocol whereby said patient data is communicable
`from said patient location to said analysis location.
`Preferably said predetermined signal comprises a modu(cid:173)
`lated audio tone.
`Preferably said modulated audio tone is a frequency
`modulated (FM) audio tone.
`Preferably said modulated audio tone has a centre fre(cid:173)
`quency between 1,000 and 3,000 Hertz.
`Preferably said centre frequency is approximately 1,900
`Hertz.
`Preferably said tone is frequency modulated at a rate of
`100 Hertz per millivolt.
`Preferably said predetermined protocol comprises direct
`modulation of an analogue wave form representing said
`patient data which is preceded by and recognised by a zero
`signal of predetermined duration.
`Preferably said predetermined signal includes said patient
`data and supplementary data; said supplementary data com(cid:173)
`prising data pertaining to the circumstances of measurement
`of said clinical data.
`Preferably said supplementary data is digitally encoded in
`a wave form suitable for frequency modulation of a carrier
`tone in the audio range.
`Preferably said predetermined protocol includes a series
`of synchronization pulses which immediately precede and
`50 signal the presence of a signal containing said supplemen(cid:173)
`tary data.
`In a particular preferred form said patient data is trans(cid:173)
`mitted as digitised packets.
`In a further particular preferred form said system includes
`55 a server computer adapted to receive said digitised packets
`of patient data.
`Preferably said server computer is adapted to transmit
`program data and patient data in the form of digitised
`packets to a remote computer whereby said remote computer
`60 can execute said program data in order to display and/or
`interpret said patient data.
`
`20
`
`BACKGROUND
`The word "telemedicine" is derived from words which
`imply the meaning far or distant medicine. The thrust and
`aim of "telemedicine" is to utilise electronic communication
`systems to transmit medical data in ways which allow the
`bringing to bear of cost effective high level expertise to
`interpretation of the information whilst also rendering the
`acquisition of the information as convenient as possible for
`the patient.
`It is at least one object of the present invention to provide
`a system which allows the achievement of a practicable
`telemedicine system.
`It is a further particular object of the invention to provide
`a system which can transmit time varying patient data in real
`time or near real time from one location to another.
`It is another further particular object of at least a preferred
`embodiment of the invention to allow the transmission of
`such data over the interconnectable network of computers
`commonly called the "internet".
`Electrocardiograph (ECG) recording has now been prac- 30
`ticed for some decades. What is recorded is the electrical
`activity of the heart obtained by the attachment of conduct(cid:173)
`ing electrodes and through which the waveforms character(cid:173)
`istic of heart activity can be obtained for analysis.
`Whilst the basic principles have been known for some 35
`time the emphasis now is on obtaining wave forms which
`reflect a patient's heart operation over a period of days or
`weeks and at a variety of heart rates and stress levels.
`Obtaining this wealth of data requires sophisticated methods
`and apparatus to capture the information and then to ensure 40
`the information obtained is properly capitalised upon.
`It is an object of the present invention to provide a
`telemedicine system and component parts therefore which
`allows the obtaining, storage and analysis of ECG data and
`like patient data which is on the one hand as convenient as 45
`possible for the patient and on the other hand capitalises on
`the volume of data obtained.
`
`BRIEF DESCRIPTION OF INVENTION
`
`Accordingly, in one broad form of the invention, there is
`provided a method of communication of patient data
`acquired from a patient; said method including arranging a
`predetermined communications protocol whereby patient
`data is communicable from a patient location to an analysis
`location.
`Preferably said method is implemented by a system which
`includes at least the following components:
`(a) patient data acquisition apparatus
`(b) patient data transmission apparatus
`( c) patient data reception apparatus
`( d) patient data storage and analysis apparatus.
`In a particular preferred form said storage and analysis
`apparatus is implemented on a personal computer.
`In a further particular preferred form said patient data 65
`transmission apparatus additionally includes supplementary
`data insertion means.
`
`BRIEF DESCRIPTION OF DRAWINGS
`Embodiments of the invention will now be described with
`reference to the accompanying drawings wherein:
`FIG. 1 is a schematic diagram of an ECG system accord(cid:173)
`ing to a first embodiment of the invention.
`
`Fitbit, Inc. v. Philips North America LLC
`IPR2020-00828
`
`Fitbit, Inc. Ex. 1017 Page 0012
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`

`US 6,820,057 Bl
`
`3
`FIG. 2 illustrates typical wave forms which can be dis(cid:173)
`played and analysed by at least portions of the apparatus of
`FIG. 1.
`FIG. 3 is a logic flow diagram for the system of FIG. 1.
`FIG. 4 is a general layout of a system according to a
`second embodiment of the invention.
`FIG. 5 illustrates a signal format suitable for use with the
`system of FIG. 4.
`FIG. 6 illustrates signals suitable for use with the signal 10
`format for FIG. 5.
`FIG. 7 is a general layout of a system according to a third
`embodiment of the invention implementable via the Internet.
`FIG. 8 is a general layout of a system according to a fourth
`embodiment of the invention.
`FIG. 9 illustrates the data block structure where the data
`acquisition device is a biolog ECG single lead device.
`
`DETAILED DESCRIPTION OF PREFERRED
`EMBODIMENTS
`
`4
`4. The Storage and Analysis Device Hardware
`In this embodiment the storage and analysis device takes
`the form of a personal computer adapted to receive the ECG
`and supplementary data from the receiver/decoder device by
`5 way of one or more of serial link, infared link or other bus
`connected communications card where forms and other data
`can be displayed on the PC or printed by means of printing
`devices connected to the PC.
`With reference to FIG. 4 a further preferred arrangement
`according to a second embodiment of the invention is
`illustrated and comprises an ECG acquisition device 30
`adapted to transmit the signal format of FIG. 5 over the
`public switched telephone network to a demodulator unit 31
`for transmission of the demodulated signal to personal
`computer 32. Optionally an answering machine 33 and a
`15 printer 34 can operate in parallel with the demodulator unit
`31. The medical data including the ECG signal acquired by
`device 30 can be stored and displayed on personal computer
`32 utilizing the data base software previously described.
`With reference to FIG. 7 there is shown a further embodi-
`20 ment of the invention implementable on an interconnectable
`network of computers, for example of the type currently
`called "the internet".
`The Internet in its present form is perhaps best described
`as an interconnectable network of computers adapted for
`25 interconnection using standardised protocols and wherein
`the individual computers making up the network at any
`given time include computers adapted to store and forward
`packets of digital information. The digital packets of infor(cid:173)
`mation are thereby able to be passed from computer to
`30 computer until they reach the destination computer whose
`address is included as part of the packet.
`In this context and with reference to FIG. 7 a telemedicine
`system 40 according to a third preferred embodiment of the
`invention is adapted for transmission and reception of
`35 patient data and supplementary data over an interconnect(cid:173)
`able network of computers of the type generally described as
`the internet 41.
`In this instance the elements of the system 40 further
`include a client personal computer 42 in communication
`40 with a patient data acquisition device such as, for example,
`an ECG acquisition device of the type described in the
`applicant's U.S. Pat. No. 5,123,419. In an alternative form
`a patient 44 can be directly connected to the client personal
`computer 42 by means of a universal ECG interface cable of
`45 the type described in the applicant's co pending Australian
`provisional patent application entitled "Universal ECG
`Interface Cable" filed 10 Jan. 1997.
`The client PC 42 to internet 41 connection 45 can be via
`the public switched telephone network as typically provided
`by Internet Service Providers and can take the form of an
`analog telephone connection, a cellular telephone connec-
`tion or a cable or other broad band connection.
`The system 40 further includes a central server computer
`46 in communication with the internet 41 via connection 47.
`The server computer 46 is adapted, as a minimum, to
`receive and store patient data including ECG data in the
`manner described in respect of the embodiments of FIG. 1
`and FIG. 4 so that in its reduced form PSTN communicated
`information directly from ECG acquisition device 30 of the
`second embodiment communicating via an acoustic cou(cid:173)
`pling to demodulation unit 31 and thence to central server
`computer 46.
`The management software described with reference to the
`first and second embodiments can operate on central server
`computer 46 and in the internet implementation of the third
`embodiment is supplemented and enhanced with the follow-
`ing capabilities:
`
`With reference to FIG. 1 there is shown an ECG system
`10 and ECG recording/logging device 11 adapted for con(cid:173)
`nection via conducting electrodes 12 to a patient 13 whereby
`ECG data as one example of patient data can be acquired
`from the patient 13. The data is encoded, in this embodiment
`together with supplementary data inserted by the logging
`device 11, by ECG transmitter 14.
`In this instance the ECG data together with the supple(cid:173)
`mentary data is encoded for transmission over the Public
`Switched Telephone Network (PSTN) 15 whereby the ECG
`data is transmitted from the patient location to an analysis
`location at which is located ECG receiver decoder 16. The
`receiver decoder 16 extracts the ECG data together, in this
`instance, with the supplementary data from the transmission
`medium for supply to ECG storage and analysis device 17.
`In this instance the storage and analysis device 17 is in the
`form of a personal computer loaded with appropriate soft(cid:173)
`ware to allow the personal computer to perform an ECG
`storage and analysis function.
`FIG. 2 shows a typical display available from the ECG
`storage and analysis apparatus 17.
`FIG. 3 is a logic flow diagram in broad form for the
`system of FIG. 1.
`Particular aspects of this system will now be described in
`greater detail:
`1. The Recording/Logging Device
`This device can take the form of commercially available
`equipment adapted to manage the electrical connection to a 50
`patient and the reception of ECG signals from the patient.
`Suitable devices available from the assignee of the present
`application include the "Biolog"™ and the "Heart Tel"™
`Cardiac Event Recorder.
`2. The Encoder/Transmitter Device
`This device performs the necessary coding and modula(cid:173)
`tion to allow the ECG signal together with supplementary
`data to be communicated over a communications medium
`such as the public switched telephone network 15. In the
`present embodiment the ECG signal itself is encoded and 60
`modulated as an FM signal whilst supplementary data in the
`form of patient and station identification, date and time of
`ECG recording is encoded and modulated in FSK format.
`3. The Receiver/Decoder Device
`This device demodulates the data from its carrier in order 65
`that the data may be passed to the storage and analysis
`device.
`
`55
`
`Fitbit, Inc. v. Philips North America LLC
`IPR2020-00828
`
`Fitbit, Inc. Ex. 1017 Page 0013
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`US 6,820,057 Bl
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`5
`i. The ability to send and receive patient data 48 in digital
`packet form including destination header information
`49.
`ii. The ability to send program data 50 also in digitised
`packet form.
`iii. The ability to encript or other secure at least the
`program data 50 to ensure its integrity on reception at
`destinations which can include client personal com(cid:173)
`puter 42 and specialist client personal computer 51.
`In a particular preferred form the program data 50 can
`take the form of applets such as Java (trademark) applets. In
`use patient data 48 comprising, for example, ECG wave
`forms stored at central server PC 46 and derived from client
`personal computer 42 can be communicated over internet 41
`to specialist client PC 51. In addition programs to interpret,
`display and store the patient data 48 can also be sent over the
`internet 41 in the form of program data 50 to the specialist
`client PC 51 thereby ensuring appropriate and up-to-date
`software is utilised to perform the critical task of displaying
`patient data such as ECG data.
`This system 40 can be implemented utilising the ActiveX
`set of technologies available from Microsoft Corporation.
`Further detail of this implementation and examples of its use
`is as follows.
`
`OVERVIEW
`
`The Server 46 uses Internet technologies from Microsoft
`primarily the ActiveX suite of programs and controls.
`
`2. Architectural Overview
`
`6
`effect is the ECG data from one client can be viewed by
`several other clients, with the SQL Server acting as a sort of
`hub. The Microsoft SQL Server 6.5 readtext, writetext, and
`updatetext functions allow the programmer to work with
`5 small portions of a larger BLOB, locking only the database
`page on which the update is occurring. Typically, the ECG
`files start at around 20 kilobytes in size, and can range into
`the hundreds of kilobytes, or into the megabytes for samples
`which cover the activities of a patient for an entire day. Only
`10 the writing control can cause a page to lock, and that page
`lock can only exist on the last page in the record; in other
`words, locking contention is no real issue provided all
`reading clients are at least 2049 bytes ( or whatever the SQL
`Server 6.5 page size has been tuned to plus one) "behind" the
`15 writing client.
`2.4 The ECG Data Record Filter (PutPatientECG.dll).
`The filter is responsible for inserting new Patient ECG
`records into the ECG recording table.
`The submission of new ECG data occurs over a standard
`HTTP 1.0 after the ActiveX control commences the opera(cid:173)
`tion with a POST query. This application operates in much
`the same way as the GetPatientECG.dll, but in reverse.
`It is implemented as an ISAPI filter, and not an ISAPI
`application. In order to maintain a high level of
`25 performance, Microsoft chose to implement ISAPI applica(cid:173)
`tions behind several performance-enhancing buffering
`mechanisms. This presented a problem as Microsoft Internet
`Information Server continually tries to buffer all of the
`information it receives for a POST query, and then send it to
`30 the ISAPI application in one large chunk of data. This is not
`satisfactory for a real-time system.
`Fortunately, ISAPI filters allow raw access to any data
`coming into the web server. Using a filter, it is possible to
`process the data in chunks, delimited by a carriage return
`and line feed.
`
`20
`
`The most noteworthy elements in the Internet Server 46
`are:
`2.1 The Microsoft SQL Server Patient Data Table.
`This table stores all information relevant to the patient, 35
`excluding the actual ECG recordings. The patient images are
`stored in the database as a series of BLOBs (Binary Large
`Objects) is extracted on-the-fly by an ISAPI application.
`2.2 The Microsoft SQL Server ECG Data Table.
`This table stores the individual ECG recordings for each
`patient. This includes Start/Finish times, descriptive
`information, etc. The ECG Data itself is stored in the
`database as a series of BLOBs is extracted on-the-fly by an
`ISAPI application.
`2.3 The ECG Data Playback Application 45
`( GetPatientECG .dll).
`GetPatientECG.dll is responsible retrieving the ECG data
`from the server for playback. For prerecorded sessions,
`GetPatientECG.dll writes all available ECG data to the
`client ActiveX control as quickly as the network infrastruc- 50
`ture will allow.
`ECG data is sent via a standard HTTP 1.0 connection, as
`a result of the ActiveX control issuing a GET query. If an
`ECG record is marked as "real-time", all data currently in
`the record is written to the client as quickly as the network
`infrastructure will allow. Once the data which was buffered
`in the SQL Server is sent, new data is read from the BLOB
`in 2K chunks as they are written to the database by the
`control which is recording the ECG. This process continues
`until he "real-time" flag is set to false, at which time, all 60
`remaining data in the SQL Server record is sent to the client.
`This allows users to upload data in 2K chunks, while another
`users (limited only by machine speed and bandwidth) are
`downloading. The only limitation that the 2K chunks of
`ECG data are inserted within a reasonable time frame such 65
`that the ECG control reading the data out of the BLOB field
`does not experience too high a number of "time outs". The
`
`3. The ActiveX Control
`
`The ActiveX control provides the following facilities:
`40 1. ECG Data upload and download between the Control and
`the ECG Server.
`2. Real-time visual playback of the ECG data stream.
`3. Real-time expert system processing of the ECG stream to
`recognise the QRS complex (patient heart beat).
`4. Recording and updating of the patient's current heart rate
`based on the QRS detection.
`The ActiveX control's architecture provides internal
`abstraction from the complexities of Internet and asynchro(cid:173)
`nous serial communications.
`As mentioned before, the control carries out all commu(cid:173)
`nications with the ECG server over HTTP 1.0 connections,
`with Microsoft Internet Information Server brokering the
`"transactions" between the control and the database.
`To simplify the design of the demonstration system, the
`55 system does not allow end users to create new patients.
`Instead, an end user who wishes to record a new ECG
`attaches that ECG to an existing patient record. As stated,
`this is only a demo, so security features such as SSL and user
`authentication are not issues at this time.
`The ActiveX control is structured in two components,
`ECGControl.ocx and mmidetct.dll. ECGControl.ocx is the
`actual control itself, and is responsible for all display and
`host communication functions. Mmidetct.dll provides the
`expert system analysis of the ECG for QRS complex (heart
`beat) detection. Internally, the control passes data to its own
`drawing routines, while simultaneously passing that data to
`the QRS detection dll for analysis.
`
`Fitbit, Inc. v. Philips North America LLC
`IPR2020-00828
`
`Fitbit, Inc. Ex. 1017 Page 0014
`
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`

`US 6,820,057 Bl
`
`8
`
`5
`
`10
`
`15
`
`7
`3.1 The HTML and VBScript Page which instantiates and
`Controls the Control for Playback.
`The VBScript on the playback page is responsible for
`bringing all of the visual user interface elements together
`and presenting them to the user. These elements are:
`1. Setting of properties and invocation of methods on the
`ECGControl.
`2. Analysis of heart rate with respect to patient age for
`aerobic exercise commentary. Presentation of this data in
`a floating frame.
`3. Presentation of the "Patient Card" in a floating frame.
`4. Presentation of the "Help" in a floating frame.
`5. Presentation of the "ECG Notes" in a floating frame.
`The VBScript on the record page provides an overlap in
`functionality with the VBScript on the playback page.
`In terms of the presentation of information in the floating
`frame, both pages are identical. They do differentiate when
`it comes to how the scripts handle the ECGControl.
`In the case of recording a new ECG, prior to the actual
`recording taking place, the VBScript sets several properties
`on the ECG control which effectively "let it know" what the
`title of the ECG is, which patient the ECG is for, and what
`notes should be attached. The ECG control submits this
`information to the database when it opens a connection to
`submit the first packet of ECG data.
`In this example utilising active-X control the ECG records
`( or other patient data) are buffered in the client PC 51 prior
`to display. Display takes place only when sufficient data is
`available to provide a full ECG ( or equivalent) trace for
`display at the same rate that the data was originally acquired. 30
`This arrangement can be described as pseudo-real-time in
`that the display is viewed at the same rate as recordal takes
`place although time delayed.
`With reference to FIG. 8 a telemedicine system 50 accord(cid:173)
`ing to a fourth embodiment of the invention is illustrated in 35
`block diagram form. The system is, in essence, the same as
`that of the embodiment of FIG. 4 in that it uses the public
`switched telephone network for communication with a per(cid:173)
`sonal computer 51 via modem 52 operating database soft(cid:173)
`ware.
`In this instance, however, the "front end" entails use of a
`portable, data acquisition device such as the biolog previ(cid:173)
`ously described. Once patient data has been acquired by the
`data acquisition device 53 it is connected via its serial port
`to a GSM mobile phone 54. The mobile phone 54 acts as a
`modem for the digital data derived from data acquisition
`device 53 which places the digital data on the GSM mobile
`telephone network 55 for subsequent transmission to the
`public switched telephone network 56 for ultimate reception
`and demodulation by modem 52 and interpretation and 50
`storage on personal computer 51.
`As for the Internet version previously described with
`reference to FIG. 7 the digital data comprising both patient
`data 48 and a header 49 containing supplementary data is the
`preferred format for transmission. A Typical format is shown 55
`in FIG. 9.
`2.0 Overall Structure
`The Direct Connect Serial Communications Protocol has
`two modes:
`Command Mode:
`for establishing communications
`querying the identity and capabilities of the device
`querying and changing the configuration or operation of
`the device
`Data Transfer Mode:
`for transferring the actual data (for example an ECG)
`from the device
`
`Command Mode
`Command mode is the default mode for the device. it is
`used to:
`establish communications
`query the identity and capabilities of the device
`query and change the configuration or operation of the
`device
`Communications are initialsised at 9600 baud, 8 data bit,
`1 stop bit and no parity. The devices may subsequently
`negotiate a higher baud rate if supported.
`Commands and responses in Command Mode are gener(cid:173)
`ally simple ASCII text, terminated by the <CR> character.
`Commands may be followed by a parameter(s), also simple
`ASCII. Command and parameters are separated by a space
`character. Characters are echoed by the receiving device,
`and a response is required to all commands. Commands are
`case sensitive.
`The standard acknowledgment is OK. Any other response,
`other than a valid response or data string should be consid(cid:173)
`ered a "not acknowledge" or "error"
`When a response (other than OK) is returned, multiple
`items are separated by semicolons (and terminated by a
`<CR>).
`All devices should respond, at a minimum to ENQ, ID,
`DATA, and TEST.
`Data Transfer Mode
`Once data Transfer has been requested (by DATA
`command), Data Transfer Mode is started. This mode uses
`XModem protocol to control packet sizes, re-e\sends, and
`error detection. Basically, the XModem data payload con-
`tains one or more Data Blocks, similar to those specified in
`the Transelephone Digital Communication Protocl. These
`Data Blocks are appended one after another, with no padding
`( except possibly for the final Block). Packetisation and error
`checking are controlled by XModem.
`Data Blocks may be broken across XModem packets, and
`if the final Data Block is shorter than the XModem packet
`size, the XModem packet is padded with (digital) zeros to
`40 the required length.
`The initial character ( C or G) specifies whether to use
`XModem or XModen-G. Packet size is determined by the
`initial byte in the first packet sent by the sending device
`( <soh>/$01=128 bytes and <stx>/$02=1024 bytes).
`Data transfer is terminated by the receiving device send-
`ing two <cancel>/$18 characters, according to the XMOdem
`standard.
`
`20
`
`25
`
`45
`
`EXAMPLES
`
`Remote Communities
`Mothers in Remote Communities
`A cardiotocograph (CTG) measures foetal well-being. A
`CTG uses two channels. One channel measures the contrac(cid:173)
`tions on the mothers uterus. The other channel measures the
`heart rate (bpm) of the foetus. These channels are both
`graphed side by side on a typical piece of ECG paper (long,
`thin strip with grid marks).
`The measurement of a deceleration (slight slowing down)
`of the heart beat of the foetus after a contraction could
`60 indicate that the foetus has an inability to cope with stress,
`specifically, the high stress of birth. Other problems may be
`detected by beat to beat variability (regularity) of the foetus
`heart rate, or acceleration (slight speeding up) of the heart
`rate.
`If no problems are detected in a foetus via a CTG, it is
`likely that no problems will occur in the immediate future.
`This gives an expecting mother some peace of mind.
`
`65
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`Fitbit, Inc. v. Philips North America LLC
`IPR2020-00828
`
`Fitbit, Inc. Ex. 1017 Page 0015
`
`

`

`US 6,820,057 Bl
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`9
`While a CTG is quite different (medically) from an ECG,
`the data which makes up a CTG could be viewed, played
`back, and stored on the Internet ECG server with trivial
`modifications to the database and ActiveX software.
`An excellent application of an Internet based CTG record/ 5
`playback system would be in many of the isolated Aborigi(cid:173)
`nal communities in "out back" Australia.
`Many Aboriginal women feel alienated in hospitals. The
`environment is unfamiliar, and does not have or play a part
`in the traditional Aboriginal culture and life style. In some
`Aboriginal communities, there is a growing trend away from
`hospital births back to births on traditional, tribal ground.
`A midwife in Arnhem land might have the ability to
`interpret a graph, but may not be able to distinguish many of
`the subtleties which may point to foetal problems.
`Using this system, she could relay the information to an 15
`obstetrician in Darwin in real time, and be given on-the-spot
`advice.
`In the instance where an aboriginal mother visits a
`regional health center and is made aware of potential
`problems, the mother can be remotely monitored over the 20
`inexpensive infrastructure of the Internet, and a flying doctor
`sent in if a problem is detected. The regional health center
`only requires access to 14400 bps data communications,
`which is substantially less than the requirements for existing
`telemedical systems.
`Rare or Difficult-to-diagnose Conditions
`When interpreting arrhythmia on a standard ECG, a
`general practitioner or nurse practitioner in a remote area
`may have difficulty in determining the type of arrhythmia
`and proper treatment. Time may be critical! A broad com-
`plex tachyarrythmia may be either a; Supraventricular tachy(cid:173)
`cardia with aberrant conduction.
`Ventricular Tachycardia.
`Both of these conditions are extremely similar in
`appearance, although Ventricular Tachycardia is far more
`sinister and probably lethal.
`Junior doctors in country areas would require specialist
`help in providing the correct diagnosis. A cardiologist
`watching in real time can interpret the ECG, provide advice,
`order treatment and watch the outcome remotely.
`
`35
`
`40
`
`Professional and Non-professional Athletes
`Professional Athletes
`Professional athletes must maintain peak fitness levels to
`guarantee ultimate performance. Athletes training overseas
`in the lead-up to an international sporting event may be 45
`disadvantaged by a lack of access to resources normally
`available to them. They could benefit by connecting with
`established diagnostic facilities in their home country, via
`Internet Telemedicine.
`Infomotio