`(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY(PCT)
`(19) World Intellectual Property
`~~
`Organization
`International Bureau
`
`(43) International Publication Date
`18 October 2012 (18.10.2012)
`
`WIPO!PCT
`
`(10) International Publication Number
`WO 2012/140559 Al
`
`AK
`
`(31)
`
`International Patent Classification:
`A61B 5/024 (2006.01)
`A61B 5/1455 (2006.01)
`A61B 5/0404 (2006.01)
`
`(21)
`
`International Application Number:
`
`PCT/IB2012/051731
`
`(22)
`
`International Filing Date:
`
`(25)
`
`(26)
`
`(30)
`
`(71)
`
`(72)
`(75)
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`(74)
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`(81)
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`Filing Language:
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`Publication Language:
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`8 April 2012 (08.04.2012)
`
`English
`
`English
`
`Priority Data:
`61/473,821
`
`11 April 2011 (11.04.2011)
`
`US
`
`except US):
`designated States
`all
`(for
`Applicant
`MEDIC4ALL AG [CH/CH]; Aegeristrasse 27, 6300 Zug
`(CII).
`
`Inventors; and
`Inventors/Applicants (for US only): SHMUELI, Ram
`[IL/IL];
`12 Nordau St., 47269 Ramat-IIasharon (IL).
`SANDLERMAN,Nimrod [IL/IL]; 44 Churgin St., 52346
`Ramat-Gan(IL).
`
`Agent: SWIRSKY, Daniel J.; AlphaPatent Associates
`Ltd., 55 Reuven St., 99544 Beit Shemesh(IL).
`
`Designated States (unless otherwise indicated, for every
`kind of national protection available): AF, AG, AL, AM,
`
`AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ,
`CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO,
`DZ, EC, EE, EG, ES, FL, GB, GD, GE, GH, GM, GT, HN,
`HR, HU, ID, IL,IN,IS, JP, KE, KG, KM, KN, KP, KR,
`KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME,
`MG, MK, MN, MW, MX, MY, MZ, NA, NG, NIL, NO, NZ,
`OM,PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD,
`SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR,
`TT, TZ, UA, UG,US, UZ, VC, VN, ZA, ZM, ZW.
`
`(84)
`
`Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW,GII,
`GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ,
`UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU,
`TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE,
`DK,EE,ES, FI, FR, GB, GR, HR, HU,IE,IS, IT, LT, LU,
`LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK,
`SM, TR), OAPI (BF, BJ, CF, CG, CL CM, GA, GN, GQ,
`GW, ML, MR, NE, SN, TD, TG).
`Published:
`
`with international search report (Art. 21(3))
`
`before the expiration of the time limit for amending the
`claims and to be republished in the event of receipt of
`amendments (Rule 48.2(h))
`
`(54) Title: PULSE OXIMETRY MEASUREMENT TRIGGERING ECG MEASUREMENT
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`Fig. 7
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`MEASURE ECG
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`CORRELEATION
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`INITIATE ECG
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`NOTIFY USER
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`STOP ECG
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`(57) Abstract: A method and a system for triggering the measurement of electrocardiogram (ECG) signal of a user. The system in-
`cludes a SpO; measuring unit and an ECG measuring unit both embeddedin a wrist-mounted device warren by the user. The method
`including the steps of: continuously measuring SpO>2at the wrist of the user, detecting an irregular heart condition from the SpO,
`measurement, notifying the user to perform an ECG measurement, and initiating the ECG measurementat least partially at the wrist.
`
`APPLE 1063
`Apple v. Masimo
`IPR2022-01291
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`
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`wo2012/140559A1[INITIMNIINIINAVTTIITAUTONM a
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`APPLE 1063
`Apple v. Masimo
`IPR2022-01291
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`1
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`WO 2012/140559
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`PCT/IB2012/051731
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`PULSE OXIMETRY MEASUREMENT TRIGGERING ECG
`
`MEASUREMENT
`
`Cross-Reference to Related Applications
`
`This application claims the priority benefit of U.S. Provisional Patent Application
`
`No. 61473821 filed April 11, 2011, which is incorporated herein by reference.
`
`Field of the Invention
`
`The present invention relates to systems and methods for patient monitoring and,
`
`moreparticularly but not exclusively, to systems and methods for monitoring heart-related
`
`events using electrocardiogram (ECG).
`
`Backgroundof the Invention
`
`Various heart diseases require the monitoring of events associated with electrical
`
`activity of the heart. The electrical activity is typically monitored by measuring an
`
`electrocardiogram (ECG). Someheart diseases are reflected in permanent irregularities of
`
`the ECG signal. Other heart diseases are reflected in transient, very short-time,
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`irregularities of the ECG signal. Some heart diseases are reflected in events of irregular
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`ECGsignal.
`
`Measuring ECG typically requires connecting the patient to an ECG measuring
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`device via a plurality of wires connected to the patient in predefined places of the body. If
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`the heart-related event is short enough the patient does not have the time to find an ECG
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`device, to properly wire the device to the body and then take the ECG measurement.
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`One commonsolution is a telemetry ECG device that is wired to the patient and
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`transmits the ECGsignalto a near-by telemetry station. Such devices are used in hospitals
`
`where it is important to monitor the patients at all time and also enable them mobility
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`within the hospital ward. However,
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`this
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`solution has
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`the disadvantage of the
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`communication range of the ECG monitoring device.
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`Another common solution is a Holter device, which is practically a small ECG
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`device connected to the patient
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`for typically 24 hours,
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`recording the ECG signal.
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`Hopefully, the heart-related event occurs during the recording time. The Holter does not
`
`limit the mobility range of the patient but has a time limit of its operation. For events that
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`are not sufficiently frequent this solution does not work. Also important and highly
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`disadvantageous is the Holter device uses electric contacts at the end of electric cables.
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`Thus, the patient has to be constantly wired to the Holter device.
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`All such solutions require uncomfortable fixed wiring of the patient to the ECG
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`device at all time. Solutions require uncomfortable fixed wiring are therefore inappropriate
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`for monitoring infrequent events of irregular ECG. There is thus a widely recognized need
`
`for, and it would be highly advantageous to have, a method and a system for measuring the
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`ECG signal associated with an intermittent irregular heart-related event, devoid of the
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`above limitations.
`
`The following patents and patent applications are believed to represent the most
`
`relevant prior art: US patents 5,176,137, 7,598,878, and 7650176; US patent applications
`
`20020095092, 20030229276, 20070038050, 20090247848, and 20090326356; and PCT
`
`applications WO2001017420, and WO20090749835.
`
`Summaryof the Invention
`
`According to one aspect of the present invention there is provided a method for
`
`triggering measurement of electrocardiogram (ECG) signal of a subject,
`
`the method
`
`including the steps of: continuously measuring SpO2at least one of a wrist and a finger of
`
`the subject, detecting an irregular heart condition from the SpO2 measurement, notifying
`
`the subject to perform an ECG measurement, and initiating ECG measurementat least
`
`partially at the wrist.
`
`According to another aspect of the present invention there is provided a method for
`
`triggering ECG measurement where the step of notifying the subject to perform an ECG
`
`measurement includes at least one of the acts of: notifying the subject to perform an ECG
`
`measurement repeatedly until the ECG measurement detects an ECG signal, stopping the
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`notification to the subject to perform an ECG measurement when the ECG measurement
`
`detects an ECG signal, notifying the subject when the ECG signal
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`is first detected,
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`notifying the subject that the ECG signal is being detected, notifying the subject as long as
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`the ECG signal is detected, and notifying the subject that the ECG measurement has
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`stopped.
`
`According to still another aspect of the present invention there is provided a
`
`method for triggering ECG measurement additionally including the steps of: performing
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`the SpO2 measurement while performing the ECG measurement, identifying a correlation
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`between the SpO2 measurement and the ECG measurement, and using the correlation in
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`the step of detecting an irregular heart condition from the SpO2 measurement.
`
`Yet according to another aspect of the present invention there is provided a method
`
`for triggcring ECG measurement wherethe corrclation is particular to the subject.
`
`Also according to another aspect of the present invention there is provided a
`
`method for triggering ECG measurement where the ECG measurement is stopped upon
`
`detecting at
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`least one of the conditions of: the irregular heart condition stopped, heart
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`condition returned to normal, a predefined period elapsed, and a predefined number of
`
`heart beats counted.
`
`Further according to another aspect of the present invention there is provided a
`
`method for triggering ECG measurement where the SpO2 measurement includes using
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`reflective SpO2 measurement.
`
`Yet further according to another aspect of the present invention there is provided a
`
`method for triggering ECG measurement where the ECG measurement additionally
`
`includes the steps of: providing at
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`least two separate conductive areas configured to
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`measureelectrical activity of the subject, performing at least one of the steps of: contacting
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`a first conductive area to at least a portion of the wrist, and a second conductive area to a
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`finger of a second hand of the subject, contacting a first conductive area to at least a
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`portion of the wrist, and a second and a third conductive areas to two fingers of a second
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`hand of the subject, and contacting a first and a second conductive areas to at least a
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`portion of the first hand and a third conductive area to a second hand of the subject;
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`extracting an ECG signal from the conductive areas by using one conductive area as a
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`reference and amplifying the differential voltage between at least two other conductive
`
`areas; and continuously converting the at
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`least one measurement
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`to form medical
`
`information.
`
`Still further according to another aspect of the present invention there is provided a
`
`method for triggering ECG measurement where the ECG measurement additionally
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`includes the step of: communicating at least one of the SpO2 measurement, the ECG
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`measurement, and the medical information to at least one of a gateway and a remote
`server.
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`According to yet another aspect of the present invention there is provided a wrist-
`
`mounted physiological parameters measuring device including: an SpO2 measuring unit
`
`attached to a wrist of a subject the SpO2 measuring unit being operative to continuously
`
`measure SpO2 at the wrist of the subject, an ECG measuring unit attached to the wrist of
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`the subject for measuring ECG signal at Icast partially at the wrist, and a processor
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`operative to control both the SpO2 measuring and the ECG measuring unit, where the
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`processor is operative to detect an irregular heart condition from the SpO2 measurement,
`
`to notify the subject to perform an ECG measurement upon detecting the irregular heart
`
`condition the, and to initiate the ECG measurement.
`
`According to still another aspect of the present invention there is provided a wrist-
`
`mounted physiological parameters measuring device where the processor is additionally
`
`configured to perform at least one of the procedures selected from the group including of: a
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`procedure for notifying the subject to perform an ECG measurement repeatedly until the
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`ECG measurement detects an ECG signal, a procedure for stopping the notification to the
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`subject to perform an ECG measurement when the ECG measurement detects an ECG
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`signal, a procedure for notifying the subject when the ECG signal is first detected, a
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`procedure for notifying the subject that the ECG signal is being detected, a procedure for
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`notifying the subject as long as the ECGsignalis detected, and a procedure for notifying
`
`the subject that the ECG measurement has stopped.
`
`Further according to another aspect of the present invention there is provided a
`
`wrist-mounted physiological parameters measuring device where the processor
`
`is
`
`additionally configured to perform at least one of the procedures selected from the group
`
`including of: a procedure performing the SpO2 measurement while performing the ECG
`
`measurement, a procedure for identifying a correlation between the SpO2 measurement
`
`and the ECG measurement, and a procedure for detecting the wregular heart condition
`
`from the SpO2 measurement using the correlation.
`
`Still further according to another aspect of the present invention there is provided a
`
`wrist-mounted physiological parameters measuring device where the correlation is
`
`particular to the subject.
`
`Yet further according to another aspect of the present invention there is provided a
`
`wrist-mounted physiological parameters measuring device where the processor
`
`is
`
`additionally configured to stop the ECG measurement upon detecting at least one of the
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`conditions of: the irregular heart condition stopped, heart condition returned to normal, a
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`predefined period elapsed, and a predefined numberof heart beats counted.
`
`Even further according to another aspect of the present invention there is provided
`
`a wrist-mounted physiological parameters measuring device the SpO2 measuring unit
`
`includesreflective SpO2 measurement device.
`
`Additionally according to another aspect of the present invention there is provided
`
`a wrist-mounted physiological parameters measuring device where the ECG measurement
`
`unit
`
`includes at
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`least two separate conductive areas configured to measure electrical
`
`activity of the subject, where the at least three conductive areas arranged in one of the
`
`following configurations: a first conductive area configured to be in contact with at least a
`
`portion of the wrist, and second conductive area configured to be touched by a finger of a
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`second hand of the subject, a first conductive area configured to be in contact with atleast
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`a portion of the wrist, and second and third conductive areas configured to be touched by
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`two fingers of a second hand of the subject, and a first and a second conductive areas
`
`configured to be in contact with at least a portion of the first hand and a third conductive
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`area configured to be touched by a second hand of the subject, where the ECG signalis
`
`extracted from the three conductive areas by using the signal of one conductive area as a
`
`reference and amplifying the differential voltage between the other two conductive areas,
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`and where the processor is operative to continuously convert the ECG signal to form
`
`medical information.
`
`Also according to yet another aspect of the present invention there is provided a
`
`wrist-mounted physiological parameters measuring device additionally including a
`
`communication unit operative to communicate at least one of the SpO2 measurement, the
`
`ECG measurement, and the medical information to at least one of a gateway and a remote
`server.
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`Unless otherwise defined, all technical and scientific terms used herein have the
`
`same meaning as commonly understood by one of ordinary skill in the art to which this
`
`invention belongs. The materials, methods, and examples provided herein are illustrative
`
`only and not intendedto be limiting.
`
`Implementation of the method and system of the present
`
`invention involves
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`performing or completing certain selected tasks or steps manually, automatically, or a
`
`combination thereof. Moreover, according to actual instrumentation and equipment of
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`preferred embodiments of the method and system of the present invention, several selected
`
`steps could be implemented by hardware or by software on any operating system of any
`
`firmware or a combination thereof. For example, as hardware, selected steps of the
`
`invention could be implemented as a chip or a circuit. As software, selected steps of the
`
`mvention could be implemented as a plurality of software instructions being executed by a
`
`computer using any suitable operating system. In any case, selected steps of the method
`
`and system of the invention could be described as being performed by a data processor,
`
`such as a computing platform for executing a plurality of instructions.
`
`Brief Description of the Drawings
`
`The invention is herein described, by way of example only, with reference to the
`
`accompanying drawings. With specific reference now to the drawings in detail,
`
`it
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`is
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`stressed that the particulars shown are by way of example and for purposesof illustrative
`
`discussion of the preferred embodiments of the present invention only, and are presented in
`
`order to provide what is believed to be the most useful and readily understood description
`
`of the principles and conceptual aspects of the invention. In this regard, no attempt is made
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`to show structural details of the invention in more detail
`
`than is necessary for a
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`fundamental understanding of the invention,
`
`the description taken with the drawings
`
`making apparent to those skilled in the art how the several forms of the invention may be
`
`embodiedin practice.
`
`In the drawings:
`
`Fig. 1A is a simplified illustration of a front view of a wrist-mounted heart
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`monitoring device with two ECG sensors in the front side and onein the back side;
`
`Fig. 1B is a simplified illustration of a back view of a wrist-mounted heart
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`monitoring device with two ECGsensorsin the front side and onein the back side;
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`Fig. 2A is a simplified illustration of a front view of a wrist-mounted heart
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`monitoring device with one ECG sensorsin the front side and twoin the back side;
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`Fig. 2B is a simplified illustration of a back view of a wrist-mounted heart
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`monitoring device with one ECG sensorsin the front side and two in the back side
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`Fig. 3 is a simplified illustration of the wrist-mounted heart monitoring device of
`
`Figs. 1A and 1B warn and used by a subject;
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`Fig. 4 is a simplified illustration of the wrist-mounted heart monitoring device of
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`Figs. 2A and 2B warn and used by a subject;
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`Fig. 5 is a simplified illustration of the wrist-mounted heart monitoring device
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`having a ring-mounted oximeter sensor warn and used by a subject;
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`Fig. 6 is a simplificd block diagram of the hcart monitoring device; and
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`Fig. 7 is a simplified flow chart of a software program preferably executed by the
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`processorof the wrist-mounted heart monitoring device.
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`Detailed Description of the Invention
`
`The principles and operation of a combined oximetry and electrocardiogram
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`measuring system and a method according to the present
`
`invention may be better
`
`understood with reference to the drawings and accompanying description.
`
`Before explaining at least one embodiment of the invention in detail,
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`it
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`is to be
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`understood that the invention is not limited in its application to the details of construction
`
`and the arrangement of the components set forth in the following description orillustrated
`
`in the drawings. The invention is capable of other embodiments or of being practiced or
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`carried out in various ways. In addition,
`
`it is to be understood that the phraseology and
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`terminology employed herein is for the purpose of description and should not be regarded
`
`as limiting.
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`In this document, an element of a drawing that is not described within the scope of
`
`the drawing and is labeled with a numeral that has been described in a previous drawing
`
`has the same use and description as in the previous drawings. Similarly, an element thatis
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`identified in the text by a numeral that does not appear in the drawing described by the text
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`has the same use and description as in the previous drawings where it was described.
`
`In this document, unless otherwise specified, the terms "oxygen saturation in the
`
`blood",
`
`"blood
`
`oxygen
`
`saturation",
`
`“pulse
`
`oximeter”,
`
`oximetry,
`
`SpQ2,
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`and
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`photoplethysmography have the same meaning and may be used interchangeably, except
`
`for those places where a difference between such terms is described. Similarly, the terms
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`ECG, EKG,electrocardiogram, and electrocardiograph have the same meaning and may be
`
`used interchangeably unless otherwise specified. Additionally, the terms user, subject and
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`patient may refer to the sameentity, unless otherwise stated.
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`Oximetry and ECG are well known techniques and there are various devices for
`
`measuring each. US patent 7650176 (Sarussi) teaches reflective measurement of Oxygen
`
`saturation in the blood. Sarussi describes a device mounted on the wrist of a human
`
`subject, or on an ankle of a baby with a reflective oximetry sensor mounted at the back
`
`side of the device and facing the skin of the subject. US patent application 20020095092
`
`(Kondo) also teaches reflective oximetry at the wrist. Additionally, US patent application
`
`20070038050 (Sarussi)
`
`teaches a wrist-worn measuring device with a finger-wom
`
`reflective oximetry sensor. PCT application WO2001017420 (Lindberg) teaches a further
`
`method of reflective oximetry. None of these teaches the use of ECG measurements with
`
`oximetry.
`
`Deriving heart beat rate from oximetry, as well as other artifacts of the heart
`
`activity and blood flow,
`
`is also knownin the art, as can be seen in US patent 5,176,137
`
`(Ericson) and US patent applications 20030229276 (Sarussi) and 20090247848 (Baker).
`
`US patent applications 20100268040 (Ben Oren) and 20090326356 (Kracker)
`
`discuss combination of oximetry and ECG measurements. Both documents assume that
`
`both the oximetry device and the ECG device are connected to the patient at all times.
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`Thus a combined measurementis possible.
`
`US patent No. 7,598,878 (Goldreich) describes a wrist mounted device equipped
`
`with an ECG measuring device and a SpO, measuring device. However, Goldreich does
`
`not teach interrelated measurements of ECG and SpOQ).
`
`The prior art does not consider a requirement to enable a patient to perform ECG
`
`measurement as soonas an irregular heart activity develops and without requiring the ECG
`
`to be constantly wired to the patient.
`
`The present invention resolves this problem by providing a combined oximetry and
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`electrocardiogram measuring system and a method in which the oximetry measurementis
`
`performed continuously and/or repeatedly, and the ECG measurementis triggered upon
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`detection of an intermittent irregular heart-related event. The present invention preferably
`
`performs measurements of intermittent irregular heart-related events without requiring the
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`fixed wiring of the ECG deviceto the patient.
`
`Reference is now made to Figs. 1A and 1B, which are simplified illustrations of
`
`two views of a wrist-mounted heart monitoring device 10 according to a preferred
`
`embodimentof the present invention.
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`As shown in Fig. 1A,
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`the heart monitoring device 10 preferably includes a
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`monitoring unit 11 and a wearing accoutrement 12 such as a band, a strap or a bracelet, for
`
`attaching the monitoring unit 11 to a wrist of the monitored subject. It is appreciated that
`
`the accoutrement 12 can be a flexible band or a band equipped with a fastening article such
`as a hook and loopfastener (Velcro’™) strip or any other type of fastener. It is appreciated
`
`that the heart monitoring device 10 can be attached to other parts of the body such as the
`
`ankle.
`
`As shown in Figs. 1A and 1B,
`
`the heart monitoring device 10 is preferably
`
`equipped with two types of sensing devices: and oximetry (SpO2) measuring unit and an
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`ECG measuring unit. The oximetry measuring unit preferably includes an oximetry sensor
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`13 mounted in the back side of the monitoring unit 11 and facing the skin of the subject.
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`The ECG measuring unit preferably includes at
`
`least three areas 14, each providing
`
`electrical contact with the subject. As shown in Figs. 1A and 1B, at
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`least one of the
`
`electrical contacts 14 designated by the numeral 15 is mounted in the back side of the
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`monitoring unit 11 and facing the skin of the subject, and at least two electrical contacts 14
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`designated by the numeral 16 are mounted on the front side of the monitoring unit 11.
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`It is appreciated that instead of, or in addition to, the oximetry (SpO2) measuring
`
`unit the heart monitoring device may include a unit for measuring CO, content in the
`
`blood.
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`It is further appreciated that the oximetry (SpO2) measuring unit can be mounted on
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`the inner side of a ring or a clip worn on a finger of the hand wearing the heart monitoring
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`device 10.
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`It is further appreciated that it is possible to measure ECG signals with only two
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`electrical sensors contacting the subject, for example, one contact touching the wrist and
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`the other contact touched by a finger of the other hand.
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`As shownin Figs. 1A, the heart monitoring device 10 may optionally include a user
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`interface, preferably containing a display 17 and one or more buttons 18 for operating the
`
`device, and a sound producing device 19 for providing audible alerts to the user.
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`Reference is now made to Figs. 2A and 2B, which are simplified illustrations of
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`two views of a different version wrist-mounted heart monitoring device 20 of an
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`alternative configuration according to a preferred embodimentof the present invention.
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`As shown in Figs. 2A and 2B, a monitoring unit 21 of the heart monitoring device
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`20 is similar to the monitoring unit 11 except that it preferably contains one ECG sensing
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`contact 14 designated by the numeral 22 mounted in the front side and two ECG sensing
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`contact 14 designated by the numeral 23 mounted in the backside.
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`Reference is now made to Figs. 3 and 4, which are simplificd illustrations of the
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`wrist-mounted heart monitoring device warn and used by a subject according to a preferred
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`embodimentof the present invention.
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`As shown in Fig. 3, the heart monitoring device 10 is preferably warren on the
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`wrist of the first hand of the subject. The oximetry sensor 13 (not shown) preferably faces
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`the front side of the hand. One electrical contact (not shown) mounted onthe back side of
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`the heart monitoring device 10 touches the skin of the subject at the wrist, and two of the
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`fingers of the second hand of the subject touch the two electrical contacts 14 on the front
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`side of the heart monitoring device 10.
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`Alternatively, the heart monitoring device 10 may be equipped with twoelectrical
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`contacts, one electrical contact mounted in the back side of the heart monitoring device 10
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`facing the wrist and touching the skin of the wrist, and the other electrical contact mounted
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`in the front side of the heart monitoring device 10 to be touched by a finger of the opposite
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`hand.
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`As shown in Fig. 4, the heart monitoring device 20 is preferably warren on the
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`wrist of the first hand of the subject. The oximetry sensor 13 (not shown) preferably faces
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`the back side of the hand. Twoelectrical contacts (not shown) mounted on the backside of
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`the heart monitoring device 10 touch the skin of the subject at the wrist, and one of the
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`fingers of the second hand of the subject touches the electrical contact 14 on the front side
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`of the heart monitoring device 10.
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`It is appreciated that the heart monitoring device 20 can be warren facing the front
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`side of the hand and the heart monitoring device 10 can be warren facing the back side of
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`the hand.
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`Reference is now madeto Fig. 5, whichis a simplified illustrations another version
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`of the wrist-mounted heart monitoring device warn and used by a subject according to a
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`preferred embodiment of the present invention.
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`As seen, the wrist-mounted heart monitoring device 24 of Fig. 5 includes the
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`oximeter (not shown) mounted inside a ring 25 warn on a finger of the hand wearing the
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`heart monitoring device 24. The oximeter in the ring 24 is preferably connected to the
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`heart monitoring device 24, preferably by an electrical cable 26.
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`Independently,
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`the wrist-mounted heart monitoring device 24 includes a single
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`electrical contact (not shown) mounted in the back side and a second electrical contact 14
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`mounted in the front side of the heart monitoring device 24 and touched by a finger of the
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`other hand.
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`Reference is now made to Fig. 6, which is a simplified block diagram of the heart
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`monitoring device 10, and/or 20 and/or 24, according to a preferred embodiment of the
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`present invention.
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`As shown in Fig. 6, the heart monitoring device preferably includes a power supply
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`unit such as a battery 27, a memory unit 28, a processor 29, an oximetry measuring unit 30
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`with the oximetry sensor 13, an ECG measuring unit 31 with three ECG contact sensors
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`14, a user interface unit 32 preferably containing output devices such as a display 33 and a
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`sound producing device 34, and a user input device 35 for example including buttons, and
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`optionally a communication unit 36.
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`The oximetry measuring unit 30 preferably uses reflective oximetry measuring
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`technology. However,it is appreciated that other technologies for measuring SpO2 such as
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`transmittance oximetry can be used as well.
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`The memory unit 28 preferably contains software program containing instructions
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`to be executed by the processor 29, operational parameters, oximetry and ECG data
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`collected from the oximetry measuring unit 30 and ECG measuring unit 31, etc.
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`The software program contained in the memory unit 28 preferably contains various
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`proceduressuchas:
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`Procedures for operating the oximetry measuring unit 30 and ECG
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`measuring unit 31 including procedures to continuously measure SpOz signal, and
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`proceduresto initiate ECG measurements.
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`Procedures for operating the user-interface unit 32 and for interacting with
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`the user including procedures for notifying the subject to perform an ECG measurement.
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`Procedures for analyzing oximetry measurements to detect various tregular
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`heart conditions, procedure for identifying correlations between SpO2z measurement and
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`ECG measurementof a particular subject to detect user-specific irregular heart conditions.
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`Using said correlation in said step of detecting an irregular heart condition
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`from said SpO2 measurement.
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`Procedures for communicating with a gateway and/or a remote server for
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`exchanging information such as operational parameters
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`and/or SpOz and ECG
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`measurements.
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`Reference is now made to Fig. 7, which is a simplified flow chart of a software
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`program preferably executed by the processor 29 of the wrist-mounted heart monitoring
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`device according to a preferred embodiment of the present invention.
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`As shown in Fig. 7, the software program starts in element 37 by measuring SpO2.
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`The element of measuring SpQ2 (e.g. oxygen saturation in the blood). The SpOz
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`measurement is preferably executed continuously as long as the heart monitoring device is
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`operative. Preferably, the SpOz measurement is executed using the oximetry measuring
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`unit 30 and the oximetry sensor 13.
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`The software program proceeds to element 38 to derive from the SpQ2
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`measurement physiological parameters such as pulse rate, pulse amplitude, pulse shape,
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`rate of blood flow, etc. Then,
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`the software program scans the derived physiological
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`parameters to detect various irregularities of the heart condition. The scanning for an
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`irregular heart condition preferably uses heart-irregularity detection parameters (element
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`39) stored in the memory unit 28. When an irregular heart condition is detected (element
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`40) the software program continues to element 41. However,
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`the SpO2 measurement
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`(element 37) preferably continues and optionally also the derivation of physiological
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`parameters as well as the detection of irregular heart conditions (element 38).
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`In element 41 the software program preferably initiates ECG measurement,
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`preferably by operating ECG measuring unit 31. The software program preferably
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`proceeds to element 42 to notify the user to perform an ECG measurement, preferably
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`making use of the ECG monitoring device as described and illustrated with reference to
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`Figs. 3 and 4. The software program preferably proceeds to element 43 to detect and ECG
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`signal. Preferably, determining that the ECG signal is present and appropriately detected
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`by the ECG measuring unit 31 is made using ECG detection parameters (element 44)
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`stored in the memory unit 28. The user is preferably notified (element 45) until an ECG
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`signal is properly detected (element 46), in which case the software program proceeds to
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`element 47 to notify the user that the ECG signalis detected.
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`The user notification features described with refe