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`L551 1TH. D Slflh‘v DIE I-‘AR’EEV‘! E N'I' U P C()i\~1i\"II‘ZRCI{
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`United States Patent and "l‘rudcmnrk Office
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`January 04, 2015
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`APPLICATION THAT MET THE REQUIREMENTS TO BE GRANTED A
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`APPLICATION NUMBER: 61/953, 616
`FILING DATE: March 14, 2014
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`METHODS AND APPARATUS FOR TRIGGERING DISCRETE
`ELECTROCARDIOGRAM RECORDING FROM CONTINUOUS MONITORING OF
`HEART RATE
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`UNITED STATES PROVISIONAL PATENT APPLICATION
`
`METHODS AND APPARATUS FOR TRIGGERING DISCRETE
`ELECTROCARDIOGRAM RECORDING FROM CONTINUOUS MONITORING OF
`HEART RATE
`
`Inventors:
`
`Euan THOMPSON
`
`Ravi GOPALAKRISHNAN
`
`Fei WANG
`
`
`
`
`Shay
`Shay Glenn LLP
`2755 Campus Drive, Suite 210
`San Mateo, CA 94403
`(650) 212—1700 Telephone
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`3
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`METHODS AND APPARATUS FOR TRIGGERING DISCRETE
`ELECTROCARDIOGRAM RECORDING FROM CONTINUOUS MONITORING OF
`HEART RATE
`
`INCORPORATION BY REFERENCE
`
`[0001]
`
`All publications and patent applications mentioned in this specification are herein
`
`incorporated by reference to the same extent as if each individual publication or patent
`
`application was specifically and individually indicated to be incorporated by reference.
`
`FIELD
`
`[0002]
`
`The systems, devices and methods described herein relate to the processing and
`
`analyzing of cardiac information, and in particular to processing and analyzing of continuous
`
`heart rate information from a wearable heart rate monitor to indicate when the wearer should
`
`record an ECG.
`
`BACKGROUND
`
`[0003]
`
`Wearable systems for monitoring heart rate are well known and are currently
`
`commercially available. For example, wearable monitors such as Garmin’s Vivofit Fitness
`
`Band, Fitbit, Polar Heart Rate Monitors, New Balance’s Balance Watch, Basis Bl Band, MIO
`
`Alpha, Withings Pulse, LifeCORE Heart Rate Monitor strap, and the like all provide continuous
`heart rate monitoring when worn. Other examples described in the patent literature may include
`
`US 5,8763 50, US 2009/0048526 and US 2011/0230748. Such devices typically present a
`
`continuous and/or average heart rate measurement and may be useful for fitness training.
`
`[0004]
`
`In addition to general fitness training, wearable heart rate monitors have also been
`
`proposed as capable of determining when a subject wearing the device is experiencing heart
`
`failure. For example, US 2009/0048526 describes a system and device in which heart failure
`
`may be detected by continuous monitoring of heart rate to detect heart rate variability. Similar
`
`descriptions may be found, for example, in US 8504143 and US 6532385. These references
`
`teach techniques for determining hear rate variability from hear rate monitoring.
`
`[0005]
`
`In the context of wearable heart rate monitors, however, such systems have proven
`
`ineffective, in part because of the difficulty in accurately interpreting cardiac distress based on
`
`heart rate information alone. In contrast, the gold standard measurement for analyzing heart
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`dysfunction is the electrocardiogram (ECG). An ECG (or EKG) translates the heart’s electrical
`
`activity into line tracings that can be used by a trained expert, such as a cardiologist, to
`
`powerfully interpret what a subject is experiencing. Although continuous monitoring of ECG
`
`signals would provide insight into the function of a subject’s heart, particularly subject’s at risk
`
`for cardiac disorders such as fibrillation (e.g., atrial fibrillation or afib), heart attack, irregular
`
`heartbeat, etc., continuous monitoring for ECGs is difficult and impractical, in part because of
`
`the vast amounts of data that may be generated, the requirement for continuous good contact
`
`with the subject’s skin, and the potentially low frequency of cardiac events.
`
`[0006]
`
`Ambulatory electrocardiogram (ECG) monitoring could be useful to detect transient
`
`cardiac abnormalities or problems that are difficult to detect using a standard ECG recording
`
`device. One type of device used for ambulatory ECG monitoring is an event recorder which can
`
`be worn or carried by the user to record ECG data for typically a relatively short duration. The
`
`event recorder can continuously record ECG data while only storing the most recent ECG on a
`
`rolling basis, and/or the event recorder can be activated manually by the user to record ECG data.
`
`Conventionally, the ECG data from the event recorders are sent to a receiving center or the
`
`user’s physician where the ECG data can be interpreted by a specialist. Examples of ambulatory
`
`ECG monitoring devices may be found, for example in US 8301232, US8509882, US
`
`2013/0197320, US 2014/0050321, US 2013/0331663 and US 2011/0301439, each of which is
`
`herein incorporated by reference in its entirety. US 8301232 is attached hereto as an explicit
`
`example in Appendix A.
`
`[0007]
`
`Unfortunately, it is often difficult or impossible to accurately predict when a transient
`
`cardiac issue will occur, particularly in the early stages when it may occur less often and/or with
`
`less regularity. Thus, what is needed is a system or technique whereby a subject could use an
`
`ambulatory ECG monitoring apparatus to accurately record ECG signals at times when
`
`irregularities are being experienced or immediately thereafter. Thus, what is needed are
`techniques and systems that combine the ease of a low-bandwidth heart rate measurements with
`
`the accuracy and high-bandwidth measurements of an ECG recorder. Described herein are
`
`apparatuses (including systems, devices, software, firmware and hardware) that may answer
`
`these needs.
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`

`SUMMARY OF THE DISCLOSURE
`
`[0008]
`
`Described herein are methods and apparatuses, including software, firmware and
`
`hardware (device and systems) for monitoring a subject to determine when to record and
`
`electrocardiogram (ECG). In general, these methods and apparatuses may use continuously
`
`monitored heart rate information (e.g., from a wearable heart rate monitor) to determine when a
`
`subject wearing the heart rate monitor is in cardiac distress based on analyzing the subject’s hear
`
`rate information (including, but not limited to heart rate variability). The heart rate information
`
`may be analyzed by the heart rate monitor or by a separate device (e.g., a device including a
`
`processor such as a smartphone, computer, pad, tablet, or the like). When the heart rate
`
`information indicates a potential cardiac event has or is occurring, the heart rate monitor or
`
`device (e.g., smartphone) may alter the subject to immediately (or within a short period of time,
`
`such as seconds or minutes) record an ECG using, for example, an ambulatory electrocardiogram
`
`(ECG) monitoring apparatus, such as those described, for example in US 8301232, US 8509882,
`
`US 2013/0197320, US 2014/0050321, US 2013/0331663 and US 2011/0301439.
`
`[0009]
`
`For example, described herein are methods for monitoring a subject to determine
`
`when to record an electrocardiogram (ECG). A method for monitoring a subject to determine
`
`when to record an ECG may include the steps of: continuously monitoring the subj ect’s hear rate
`
`using a wearable heart rate monitor to provide heart rate information; examining the subject’s
`
`heart rate information to determine if the subject’ s heart rate displays one or more predetermined
`
`characteristics; and alerting the subject to perform an ECG recording using an ECG recording
`
`system when the subject’s heart rate displays the predetermined characteristics. Any of the
`
`methods may also include the step of recording an ECG after altering the subject. In particular,
`
`the subject may be notified and may record their own ECG.
`
`[00010]
`
`For example, a method for monitoring a subject to determine when to record an ECG
`
`may include: continuously monitoring the subject’ s hear rate using a wearable heart rate monitor
`
`to provide heart rate information; processing the subject’s heart rate information in a processor to
`
`determine if the subject’s heart rate displays one or more predetermined characteristics; alerting
`
`the subject to perform an electrocardiogram when the subject’s heart rate displays the
`
`predetermined characteristics; and recording the subject’s ECG using a personal ECG recording
`
`device operated by the subject.
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`

`[00011]
`
`Any of these methods for monitoring a subject to determine when to record an ECG
`
`may include communicating (e. g. wirelessly) the subject’s heart rate information to a processor,
`
`such as a smartphone (e.g., AndroidTM, iPhone, etc), computer, laptop computer, tablet computer
`
`(e.g., iPad), wearable computer (Google Glass) or the like. The information may be wirelessly
`
`communicated using any appropriate modality, including electromagnet, ultrasound, optical, etc.
`
`[00012]
`
`Continuously monitoring may comprise monitoring a subject’s heart rate using a
`
`heart rate monitor worn on the subject’s wrist, arm, chest, neck, head, hand, waist, leg, foot, arm,
`
`or shoulder. Any appropriate heart rate monitor may be used, including currently commercially
`
`available heart rate monitors such as PolarTM heart rate monitors and GarminTM heart rate
`
`monitors. Such monitors may be configured to continuously transmit information about heart
`
`rate and/or to automatically analyze heart rate.
`
`[00013]
`
`In general, the heart rate information may be analyzed to determine if a subject is
`
`experiencing a cardiac event worth examining by ECG recording and analysis. For example, an
`
`apparatus or method may include analyzing the heart rate information to identify heart rate
`
`variability. Detection of heart rate variability may be made based on quantitative analysis,
`
`including the automated analysis of heart rate signals such as that described, for example, in US
`
`8504143, US 6532382 and WO 2010/077997. Alternatively or additionally, detection of a
`
`cardiac disorder may be made by comparing a pattern of heart rate information (e.g., a pattern of
`
`regional intervals, such as R-R intervals, or the like) to a database of patterns correlated with
`
`cardiac disorders. For example, a subj ect’s pattern of R-R intervals from the subject’s heart rate
`
`information may be compared to a library of R-R interval patterns characteristic of cardiac
`
`disorders. This library may be present on a local device or it may be accessed from a remote
`
`location.
`
`[00014]
`
`As mentioned, any of these methods may also include recording a subject’s ECG
`
`using a personal ECG recording device operated by the subject.
`
`[00015]
`
`Also described are non—transitory computer-readable storage medium storing a set of
`
`instructions capable of being executed by a processor, that when executed by the processor
`
`causes the processor to: receive continuous heart rate information from a heart rate monitor worn
`
`by a subject; process the subj ect’s heart rate information to determine if the subject’s hear rate
`
`displays one or more predetermined characteristics; alert the subject to record an ECG using a
`
`personal ECG recording device operable by the subject.
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`

`[00016]
`
`For example, the processor may be part of a smartphone, and the smartphone may
`
`receive the continuously monitored heart rate information and determine when to alert and/or
`
`instruct the subject to record an ECG (e. g., using an ambulatory ECG monitoring apparatus). In
`
`some variations the set of instructions causes the processor to begin preparing to take and/or
`
`receive an ECG from the patient using an ambulatory ECG monitor.
`
`[00017]
`
`For example, a non-transitory computer-readable storage medium storing a set of
`
`instructions capable of being executed by a smartphone having a processor, that when executed
`
`by the smartphone processor causes the smartphone to: receive continuous heart rate information
`
`from a heart rate monitor worn by a subject; process the subject’s heart rate information to
`
`determine if the subject’s hear rate displays one or more predetermined characteristics by
`
`comparing a pattern of the subject’s heart rate information to a database of patterns characteristic
`
`of cardiac disorders; and alert the subject to record an ECG using a personal ECG recording
`
`device operable by the subject. As mentioned, the set of instructions, when executed, may cause
`
`the processor to prepare to receive ECG information from the personal ECG recording device
`
`(e.g., an ambulatory ECG monitor). The set of instructions, when executed, may cause the
`
`processor to process the subject’s heart rate information by comparing a pattern of the subject’s
`
`R—R intervals to a database of patterns characteristic of a cardiac disorder.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[00018]
`
`FIG. 1 is illustrates a methods monitoring a subject to determine when to record and
`
`electrocardiogram (ECG).
`
`DETAILED DESCRIPTION
`
`[00019]
`
`In general, described herein are apparatuses and method of monitoring a subject to
`
`determine when to record and electrocardiogram (ECG). For example, described herein are
`
`methods of monitoring a subject by correlating information from heart rate, which may be easily
`
`and continuously monitoring using a wearable heart rate monitoring device with a high degree of
`
`tolerability by a subject, to cardiac disorders such as certain arrhythmia diseases (e. g., atrial
`
`fibrillation), in order to alter a subject to record, e.g., self—record, an ECG immediately or shortly
`
`thereafter. This may allow the subject to record a high-resolution ECG measurement at or
`
`around a time point that is of particular clinical significance. The recorded ECG may then be
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`transmitted, and/or stored for later transmission, to a physician and/or a reading/analysis service
`
`to provide the subject with further care and/or instructions, including further clinical
`
`examination.
`
`[00020]
`
`Thus, continuous heart rate (HR) monitoring may be applied through a wearable heart
`
`rate monitor, or part of an implant, etc. By analyzing the heart rate monitor output (heart rate
`
`information); to identify a potential cardiac event/period, the user may be alerted to record
`
`further information at higher resolution (e. g., ECG information).
`
`[00021]
`
`For example, a continuous heart rate monitor may provide heart rate information that
`
`is received by a processor that determines when an interesting cardiac event may be occurring.
`
`In some variations the heart rate monitor may itself analyze the heart rate. The heart rate
`
`information may be used to provide information about heart rate variability. The heart rate
`
`information may be digital or analog information and may include electrical (e. g., single lead), or
`
`optical (e. g., infrared, IR) or the like.
`
`[00022]
`
`In particular, variations in heart rate (HRV) may be determined by the application of
`
`a formula (e. g., examining beat—to-beat variability). In some variations, the heart rate
`
`information (or an extracted portion of HR information) may be used to compare to a database of
`
`similar information that has been correlated with cardiac events. For example, heart rate
`
`information may be compared to a database of HR information extracted for ECG recordings of
`
`patients known to be experimenting cardiac problems. Thus, patterns of heart rate information
`
`taken from a subject may be compared to patterns of cardiac information in a database. If there
`
`is a match (or a match within a reasonable closeness of fit), the patient may be instructed to
`
`record an ECG, e. g., using an ambulatory ECG monitor. This may then provide a more detailed
`
`view of the heart. This method may be particularly useful, as it may allow recording and/or
`
`transmission and/or analysis of detailed electrical information about the heart at or near the time
`
`(or shortly thereafter) when a clinically significant cardiac event is occurring. Thus, the
`
`continuous monitoring may allow a subject to be alerted immediately upon an indication of the
`
`potential problem (e.g., an increase in HRV suggestive of a cardiac dysfunction). This may
`
`allow the coupling of continuous HR monitoring with ECG recording and analysis for disease
`
`diagnosis and disease management.
`
`[00023]
`
`FIG. 1 illustrates one variation of a method for monitoring a subject to determine
`
`when to record an electrocardiogram (ECG). In FIG. 1, a subject 1 is wearing a continuous heart
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`rate monitor (configured as a watch 12, including electrodes 16), shown in Step 101. The heart
`
`rate monitor transmits (wirelessly 11 1) heart rate information that is received by the smartphone
`
`108, as shown in step 103. The smartphone includes a processor that may analyze the heart rate
`
`information 103, and when an irregularity is determined, may indicate 105 to the subject that an
`
`ECG should be recorded. In FIG. 1, an ambulatory ECG monitor 109 is attached (as a case
`
`having electrodes) to the phone 108. The user may apply the monitor as to their body (e.g., chest,
`
`between arms, etc.) 107 to record ECGs that can then be saved and/or transmitted for analysis.
`
`[00024] Any of the methods an apparatuses described herein may also be adapted to
`
`automatically trigger recording of an ECG (e.g., switching between receiving/analyzing just
`
`heart rate information, which may be low—density data to higher resolution ECG recordings).
`
`Although the application to home health care and self-management of monitoring by subj ect’s is
`
`described and particularly useful, these same apparatuses, methods and principles may be applied
`
`in hospital and/or clinical settings.
`
`[00025]
`
`The foregoing descriptions of specific embodiments of the present invention have
`
`been presented for purposes of illustration and description. They are not intended to be
`
`exhaustive or to limit the invention to the precise forms disclosed, and obviously many
`
`modifications and variations are possible in light of the above teaching. For example, features
`
`described in one embodiment can be used in another embodiment. The embodiments were
`
`chosen and described in order to best explain the principles of the invention and its practical
`
`application, to thereby enable others skilled in the art to best utilize the invention and various
`
`embodiments with various modifications as are suited to the particular use contemplated.
`
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`What is claimed is:
`
`CLAIMS
`
`l.
`
`A method for monitoring a subject to determine when to record an electrocardiogram
`
`(ECG), the method comprising:
`
`continuously monitoring the subject’s hear rate using a wearable heart rate
`
`monitor to provide heart rate information;
`
`examining the subject’s heart rate information to determine if the subj ect’s heart
`
`rate displays one or more predetermined characteristics; and
`
`alerting the subject to perform an ECG recording using an ECG recording system
`
`when the subj ect’s heart rate displays the predetermined characteristics.
`
`2.
`
`A method for monitoring a subject to determine when to record an electrocardiogram
`
`(ECG), the method comprising:
`
`continuously monitoring the subject’s hear rate using a wearable heart rate
`
`monitor to provide heart rate information;
`
`processing the subject’s heart rate information in a processor to determine if the
`
`subject’s heart rate displays one or more predetermined characteristics;
`
`alerting the subject to perform an electrocardiogram when the subject’s heart rate
`
`displays the predetermined characteristics; and
`
`recording the subject’s ECG using a personal ECG recording device operated by
`
`the subject.
`
`3.
`
`The method of claim 1 or 2, further comprising wirelessly communicating the subject’s
`
`heart rate information to a processor.
`
`4.
`
`The method of claim 1 or 2, wherein continuously monitoring comprises monitoring a
`
`subject’s heart rate using a heart rate monitor worn on the subject’s wrist, arm, chest, neck, head,
`
`hand, waist, leg, foot, arm, or shoulder.
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`5.
`
`The method of claim 1 or 2, wherein processing comprises comparing a subject’s pattern
`
`of R-R interval from the subject’s heart rate information to a library of R-R interval patterns
`
`characteristic of cardiac disorders.
`
`6.
`
`The method of claim 1, further comprising recording the subject’s ECG using a personal
`
`ECG recording device operated by the subject.
`
`7.
`
`A non-transitory computer-readable storage medium storing a set of instructions capable
`
`of being executed by a processor, that when executed by the processor causes the processor to:
`
`receive continuous heart rate information from a heart rate monitor worn by a subject;
`
`process the subject’s heart rate information to determine if the subj ect’s hear rate
`
`displays one or more predetermined characteristics; and
`
`alert the subject to record an ECG using a personal ECG recording device operable by
`
`the subject.
`
`8.
`
`A non-transitory computer-readable storage medium storing a set of instructions capable
`
`of being executed by a smartphone having a processor, that when executed by the smartphone
`
`processor causes the smartphone to:
`
`receive continuous heart rate information from a heart rate monitor worn by a subject;
`
`process the subject’s heart rate information to determine if the subject’s hear rate
`
`displays one or more predetermined characteristics by comparing a pattern of the
`
`subject’s heart rate information to a database of patterns characteristic of cardiac
`
`disorders; and
`
`alert the subject to record an ECG using a personal ECG recording device operable by
`
`the subject.
`
`9.
`
`The non-transitory computer—readable storage medium of claim 7, wherein the processor
`
`is part of a smartphone.
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`10.
`
`The non-transitory computer—readable storage medium of claims 7 or 8, wherein the set
`
`of instructions, when executed, causes the processor to prepare to receive ECG information from
`
`the personal ECG recording device.
`
`11.
`
`The non-transitory computer—readable storage medium of claims 7 or 8, wherein the set
`
`of instructions, when executed, causes the processor to process the subj ect’s heart rate
`
`information by comparing a pattern of the subject’s R-R intervals to a database of patterns
`
`characteristic of a cardiac disorder.
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`METHODS AND APPARATUS FOR TRIGGERING DISCRETE
`ELECTROCARDIOGRAM RECORDING FROM CONTINUOUS MONITORING OF
`HEART RATE
`
`ABSTRACT
`
`Described herein are systems for receiving continuous heart rate (HR) monitoring
`
`information, e.g., from a wearable HR monitor that, based on HR variability and particularly the
`
`variability of the R—R segments determines when to recommend that a subject take an ECG (e.g.,
`
`within a few second, minutes or hours of detection).
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`"METHODS AND APPARATUS FOR TRIGGERING DISCRETE ELECTROCARDIOGRAM RECORDING FROM CONTINUOUS MONITORING OF HEART RATE"
`Attorney No.: 12212-714100 FILED VIA EFS Sheet 1 OH
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`

`

`APPENDIX A
`Attorney No.: 12212-714.100
`
`||||||||||||l||||||ll||||||l||||lllll||||l|||||llllllllll||||||||||||||||||
`
`U8008301232B2
`
`(12)
`
`(54)
`
`(75)
`
`(73)
`
`( "‘ )
`
`(21)
`
`(22)
`
`(65)
`
`(63)
`
`(51)
`
`(52)
`(58)
`
`(56)
`
`I
`United States Patent
`(10) Patent No.:
`US 8,301,232 B2
`
`(45) Date of Patent:
`Oct. 30, 2012
`Albert et al.
`
`WIRELESS, ULTRASONIC PERSONAL
`HEALTH MONITORING SYSTEM
`Inventors: David Albert, Oklahoma City, OK (US);
`Bruce Richard Satchwell, Carrara
`(AU); Kim Norman Barnett, Mt.
`Tamborine (AU)
`
`Assignee: AliveCor, Inc., Oklahoma City, OK (US)
`,
`_
`,
`.
`,
`Notice:
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`use. 154(b) by 0 days.
`
`Appl’No" 13/420520
`Filed:
`Mar. 14, 2012
`
`Prior Publication Data
`
`US 2012/0172689 A1
`
`Jul. 5, 2012
`
`Related U.S. Application Data
`
`Continuation of application No. 13/108,738, filed on
`May 16, 2011, which is a continuation-in—part of
`application No, 12/796,188, filed on Jun. 8, 2010.
`Int. Cl.
`A61B 5/04
`600/509
`U.S. Cl.
`Field of Classification Search .................. 600/509;
`455/557
`
`(2006.01)
`
`See application file for complete search history.
`References Cited
`
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`C t'
`ed
`( 0" mu )
`FOREIGN PATENT DOCUMENTS
`
`cu
`
`10/1990
`675675 AS
`(Continued)
`
`OTHER PUBLICATIONS
`
`Oresko et al. “Detecting Cardiovascular Diseases via Real-Time
`Electrocardiogram Processing on a Smart Phone”, 2009 Workshop
`on Biomedicine in Computing:Systems, Architectures, and Circuits,
`pp, 13-163“
`
`(Continued)
`
`Primary Examiner — Mark W Bockelman
`(74) Attorney, Agent, or Firm 7 Shay Glenn LLP
`
`ABSTRACT
`(57)
`A personal monitoring device has a sensor assembly config—
`ured to sense physiological signals upon contact with a user’ s
`skin. The sensor assembly produces electrical signals repre—
`senting the sensed physiological signals. A converter assem-
`bly, integrated with, and electrically connect