(12) Unlted States Patent
`(16) Patent N0.:
`US 6,415,166 B1
`
`Van Hoy et al.
`(45) Date of Patent:
`Jul. 2, 2002
`
`USOO6415166B1
`
`(54) PHOTOPLETHYSMOGRAPHIC DEVICE
`WITH REMOTE FACSIMILE
`
`(75)
`
`Inventors: Gilbert W. Van H0y, Broomfield;
`Charles A. Gonzales, Westminster;
`David L. Newcomb, Louisville;
`
`9/1994 Hollub
`5,348,004 A
`5/1996 Galen et al.
`5,515,176 A *
`8/1996 David et al.
`5,544,649 A *
`5,581,369 A * 12/1996 Righter et al.
`5,701,894 A
`12/1997 Cherry et al.
`
`................ 128/904
`................ 128/904
`.............. 128/904
`
`Michael K. Brashears, Denver; Tricia
`A. Dessel, Boulder, all of CO (US)
`
`* cited by examiner
`
`(73) Assignee: DateX-Ohmeda, Inc., Louisville, CO
`(US)
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`( * ) Notice:
`
`(21) APP1~ N03 09/386,691
`(22)
`Filed:
`Aug. 30, 1999
`
`(63)
`
`(Under 37 CFR 1~47)
`.
`.
`Related U'S' Appllcatlon Data
`Continuation—in—part of application No. 08/938,224, filed on
`Sep. 26, 1997, now abandoned.
`A61B 5/00
`Int Cl 7
`(51)
`52 US Cl """""600/323600/333 128/904
`
`F'- ld f S""""h"""
`'
`(58)
`600 ’300 301
`’
`ear200/310322323324 333/ 128/903,
`)
`1e
`0
`(
`’
`’
`’
`’
`’
`904;
`
`(56)
`
`References Cited
`US. PATENT DOCUMENTS
`
`Primary Examiner—Eric F. Winakur
`(74) Attorney, Agent, or Firm—Marsh Fischmann &
`Breyfogle LLP
`(57)
`
`ABSTRACT
`
`Aphotoplethysmographic monitoring system such as a pulse
`oximeter collects data regarding the blood analyte concen-
`tration and pulse rate of a patient through. the analysis of
`light transm1tted form an em1tter through tlssue to a photo
`detector. It is often necessary to review the collected data,
`such as oxygen saturation, pulse rate and pulsatility value at
`a location remote to the patient being monitored. The
`photoplethysmographic SyStem. formats the. seleCFed data for
`transm1ttal
`to a remote fac51m11e machme v1a standard
`telephone communication systems using an internal or exter-
`nal modem. The formatter is able to function Within the
`processing and memory constraints of pulse oximeters by
`formatting and transmitting the data in sections. Formatted
`data may be sent via hard-Wired telephone, cellular phone,
`PCS digital telephones or through satellite communication
`systems enabling transmittal of data from a portable pho-
`toplethysmographlc system.
`
`5,078,136 A
`
`1/1992 Stone et al.
`
`19 Claims, 20 Drawing Sheets
`
`
`
`PULSE
`
`SPOZ
`GENERATOR
`
`STATISTIC &
`ALARM
`GENERATOR
`
`
`
`SIGNAL QUALITY
`MONITOR
`
`33
`MAIN MEMORY
`31
`
`GRAPH
`37
`GENERATOR
`
`
`PULSATILITY
`
`VALUE GEN
`
`
`MEMORY
`
`
`BUFFER
`MODEM
`Hmrid CPU
`
`
`
`ANALOG/SERIAL
`INTERFACE
`
`ANALOG
`TO
`
`
`DIGITAL
`CONVERTER
`
`
` 25
`
`
`PRINT MECHANISM 24
`
`
`
`
`15
`
`27
`
`PRINTER PARALLEL
`INTERFACE
`
`OUTPUT D'SPLAY
`
`PRINTER USER INPUT
`
`MODEM
`
`40
`
`
`
`1
`
`APPLE 1021
`
`APPLE 1021
`
`1
`
`

`

`US. Patent
`
`JuL2,2002
`
`Sheet 1 0f 20
`
`US 6,415,166 B1
`
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`US. Patent
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`Jul. 2, 2002
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`Sheet 2 0f 20
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`US 6,415,166 B1
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`US. Patent
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`Jul. 2, 2002
`
`Sheet 3 0f 20
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`US 6,415,166 B1
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`

`US. Patent
`
`Jul. 2, 2002
`
`Sheet 5 0f 20
`
`US 6,415,166 B1
`
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`

`US. Patent
`
`Jul. 2, 2002
`
`Sheet 6 0f 20
`
`US 6,415,166 B1
`
`PULSE OXIMETRY lNSTAREPORT
`
`601
`
`H GONZALES
`
`110
`DR CASEY
`
`GENERAL
`
`BY
`
`602
`
`COMMENTS
`
`STUDYSTARTDATE/TIME:
`STUDYENDDATEHIME:
`
`.
`
`STUDY DURATION AND VALUES
`01/02/99 000000
`01103199120000
`
`LOWSpO
`AVERAG 561%;
`SpOzSTD. E.
`
`TIME
`PR
`134BPM 00:58:05
`
`01%
`91%
`8%
`
`604
`
`605
`
`607
`503
`
`
`
`
`
`609
`
`
`
`
`
`0-70% 71-75% 76-80% 81-85% 86-90% 91-95% 96-100%
`
`Sp02
`
`PULSE OXIMETRY lNSTAREPORT
`
`PAGE 1 OF 2
`
`FIG.6A
`
` 503
`
`STUDY DURATION:
`
`12:00:00 606
`
`130
`#SIBOZVALUESBELOW85%
`TO ALDURATIONBELOW85% 00:13:34
`
`HIGHPR
`LOWPR
`AVERAGE PR
`
`100 BPM
`61BPM
`YZBPM
`
`Sp02
`90%
`30%
`
`TIME
`02:00:00
`04:58:06
`
`
`
`7
`
`

`

`US. Patent
`
`Jul. 2, 2002
`
`Sheet 7 0f 20
`
`US 6,415,166 B1
`
`PULSE OXIMETRY INSTAREPORT
`
`H GONZALES
`110
`DR CASEY
`
`GENERAL
`
`—
`
`LEGEND:
`
`601
`
`610
`
`611
`
`BY
`COMMENTS
`
`502
`
`616
`
`LOWSp02 617x§ NODATA
`
`
`
`
`
`
`
`
`613
`
`
`615
`100
`
`so 00
`pz 70
`60
`250
`200
`150
`100
`53
`
`04:00:00
`08:00@
`100
`90
`
`
`
`
`
`
`
`
`
`
`
`
`614
`
`612
`
`J
`
`J
`
`
`
`
`611
`
`613
`
`615
`
`611
`
`613
`
`615
`
`3pc2 80
`
`70
`60
`
`
`
`
`
`
`250
`200
`150
`100
`50
`0
`03:00:00
`
`PULSE OXIMETRY INSTAREPORT
`
`PAGE 2 OF 2
`
`09:00:00
`
`10:00:00
`
`11:00:00
`
`12:00:00
`
`8
`
`

`

`US. Patent
`
`Jul. 2, 2002
`
`Sheet 8 0f 20
`
`US 6,415,166 B1
`
`
`
`H GONZALES
`110
`DR CASEY
`GENERAL
`BY:
`COMMENTS:
`
`STUDY DATE:
`05/16/98
`
`+
`ALARM LEGEND
`HIGH SpO ..................................
`LOW SpOZ................................... I
`NO SENS R................................ I
`SENSOR OFF .............................. ?
`6—SECOND FORMAT
`
`716
`717
`718
`719
`
`Sp02
`50 60 70 80 90 100 Sp02
`I
`I
`|
`95
`I
`I
`I
`I
`|
`I
`|
`I
`|
`I
`
`I
`
`aI
`
`I
`
`|
`I
`
`START DATE/TIME:
`05/16/98
`12:34
`
`END DATE/TIME:
`05/16/98
`12:35
`
`STUDY DURATION:
`00:01 :00
`
`80% 84 v
`LOW Sp02
`90 v
`HIGH PR
`80 v
`LOW PR
`90%
`AVERAGE SpO
`—
`Sp02 STD.DEV2
`SUMMARY STATISTICS
`%TIME PER Sp02 RANGE
`0
`20 40 60 80100%
`90-100 — u
`l
`67
`I
`85—89
`.
`I
`;
`.
`;
`0
`I
`80-84 i.
`I
`33
`I
`|
`70-79
`;
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`;
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`0-69u
`.
`.
`.
`.
`
`||
`
`|
`I
`I
`.
`
`00
`
`TIME PER Sp02 RANGE
`90-100°/o
`00:00:24
`85-89%
`00:00:00
`80-84%
`00:00: 1 2
`70-79%
`00:00:00
`0-69%
`00:00:00
`
`
`
`# SpO2 VALUES BELOW 85%:
`
`OTAL DURATION BELOW 85%:
`00:00:12
`
`2 T
`
`9
`
`

`

`US. Patent
`
`Jul. 2, 2002
`
`Sheet 9 0f 20
`
`US 6,415,166 B1
`
`TREND DATA OUTPUT
`
`6 SECONDS PER DATA POINT
`
`P HERNANDEZ
`
`93256
`
`JP CLAIR
`
`GENERAL
`
`09/03/98
`
`14:01:31
`
`14:01:25
`
`14:01:19
`
`14:01:13
`
`14:01:07
`
`14:01:01
`
`14:00:55
`
`14:00:49
`
`14:00:43
`
`14:00:37
`
`Sp02=80
`Sp02=81
`Sp02=81
`Sp02=97
`Sp02=99
`Sp02=100
`Sp02=100
`Sp02=
`Sp02=
`Sp02=
`
`LOW SpOZ
`LOW Sp02
`LOW Spoz
`
`NO SENSOR
`
`NO SENSOR
`
`NO SENSOR
`
`
`
`804
`
`END TREND DATA
`
`FIG.8
`
`10
`
`10
`
`

`

`US. Patent
`
`Jul. 2, 2002
`
`Sheet 10 0f 20
`
`US 6,415,166 B1
`
`902
`
`MODEM STATUS
`
`SELECT DATA>
`(12) SEND DATA>
`
`SETUP MODEM>
`
`902
`
`SELECT HOURS
`
`12 HOURS
`
`(24) ALL>
`
`11
`
`

`

`US. Patent
`
`Jul. 2, 2002
`
`Sheet 11 0f 20
`
`US 6,415,166 B1
`
`902
`
`SEND DATA
`
`FAX>
`TO HOST SYSTEM>
`
`CANCEL>
`
`WAIT FOR CALL>
`
`_
`
`900
`
`900
`
`902
`
`
`
`
`
`
`4__l
`
`CID
`
`900
`
`DIAL FAX
`
`
`AFTER TONES ARE
`
`HEARD PRESS
`
`
`
`
`950
`
`1210
`1220
`0.04)
`
`FIG.12
`
`12
`
`12
`
`

`

`US. Patent
`
`Jul. 2, 2002
`
`Sheet 12 0f 20
`
`US 6,415,166 B1
`
`902
`
`SENDING DATA
`
`VII/A—
`
`.
`
`900
`
`900
`900
`900
`
`DIAL HOST SYSTEM.
`AFTER TONES ARE
`HEARD PRESS
`
`_
`
`900
`
`902
`
`WAIT FOR CALL...
`
`_
`
`900
`
`13
`
`

`

`US. Patent
`
`Jul. 2, 2002
`
`Sheet 13 0f 20
`
`US 6,415,166 B1
`
`START MENU
`
`1670
`
`DlSPLAY
`MENU
`
`1620
`
`SELEEITEON
`
`DATE
`
`
`
`
`=
`TINE
`
`
`
`DATE
`SUBROU
`
`1630
`
`
`END MENU
`
`
`
`
`
`USER INPUTS
`MENU
`SELECTION
`
`
`1640
`
`
`
`
`SELECTION=
`
`LABEL
`
`
`USER
`YES
`
`LABELS
`I SUBROUT|NE
`
`
`
`1660
`
`YES
`
`NO
`
`SETTINGS
`
`SUBROUT|NE
`
`FIG.16
`
`14
`
`MODEM
`SUBROUT|NE
`FIG.17
`
`YES
`
`USER
`SELECTION=
`
`
`MODEM
`
`
`NO 1650
`
`1645
`
`1655
`
`1665
`
`14
`
`

`

`US. Patent
`
`Jul. 2, 2002
`
`Sheet 14 0f 20
`
`US 6,415,166 B1
`
`MODEM
`
`START
`
`1720
`
`
`513%
`MENU
`
`
`SELECTIONS
`
`1770
`
`
`USER
`SELECTION:
`
`CAEPEL
`-
`
`1780
`
`YES
`
`RETURNTO
`MENU
`
`1730
`
`
`
`USERINPUTS
`MODEM
`MENU
`SELECMON
`
`
`
`
`
`1740
`
`
`DATA
`
`SELECT
`DATA
`SUBROUTINE
`FIG.18
`
`1745
`
`1755
`
`1755
`
`
`USER
`YES
`
`
`SELECHON=
`
`
`SELECT
`
`
`
`NO 1750
`
`YES
`USER
`
`
`
`SELECHON:
`SEND
`
`
`SEND
`SUB%gU%NE
`RG19
`
`SUBROUTINE
`
`15
`
`

`

`US. Patent
`
`Jul. 2, 2002
`
`Sheet 15 0f 20
`
`US 6,415,166 B1
`
`1870
`
`
`
`
`USER
`
`SELECTION=
`RETURN
`
`
`
`
`
`
`
`
`STORE
`SELECTED
`DATA IN
`
`RETURN
`
`1875
`
`1845
`
`1855
`
`1865
`
`START
`SELECT DATA
`
`
`
`
`
`DISPLAY
`SELECT
`DATA MENU
`SELECTIONS
`
`
`
`
`USER INPUTS
`DATA
`SELECTION
`
`1820
`
`1830
`
`
`
`USER
`
`SELECTION:
`STATS - STATFLAG
`
`
`NO
`
`SELLEDITIRON= YES
`
`HOURS.
`
`
`
`1840
`
`YES
`
`1850
`
`NO
`
`DISPLAY STATS
`MESSAGE SET
`
`DISPLAY NUMBER
`
`
`owggggg
`HOURS
`
`
`1860
`
`YES
`
`
`
`
`
`USER
`SELECTION:
`
`(n)ALL
`
`
`
`
`DISPLAY N HOURS
`SELECTED SET
`NUMBER OF
`HOURS
`
`
`
`
`
`FIG.18
`
`16
`
`16
`
`

`

`US. Patent
`
`Jul. 2, 2002
`
`Sheet 16 0f 20
`
`US 6,415,166 B1
`
`START
`SEND DATA
`
`
`
`DISPLAY
`SEND DATA
`AND MENU
`SELECTIONS
`
`1920
`
`1930
`
`
`
`USER INPUTS
`DATA
`SELECTION
`
`
`
`1970
`
`
`
`USER
`SELECTION:
`CANCEL
`.
`
`YES
`
`RETURN
`
`1980
`
`1940
`
`USER
`SELECTION:
`
`
`
`
`
`YES
`
`FAX
`SUBROUTINE
`FIG.20
`
`
`
`
`NO 1950
`
`YES
`
`
`
`TO HOST
`SYSTEM
`SUBROUTINE
`FIG.21
`
`TO HOST
`SYSTE
`
`
`
`USER
`CALL
`
`
`SELECTION:
`
`WAIT FOR
`
`
`1960
`
`YES
`
`
`
`
`
`WAITFOR
`CALL
`SUBROUTINE
`FIG.22
`
`
`
`
`
`
`1945
`
`1955
`
`1965
`
`FIG.19
`
`17
`
`17
`
`

`

`US. Patent
`
`Jul. 2, 2002
`
`Sheet 17 0f 20
`
`US 6,415,166 B1
`
`START
`FAX SUBROUTINE
`
`2010
`
`
`
`
`
`DISPLAY
`
`
`MESSAGE "DIAL
`FAX AFTER
`TONES ARE
`
`
`HEARD AND
`PRESS RETURN”
`
`
`
`2070
`
`
`USER
`SELECTION=
`
`CANCEL?
`
`2080
`
`
`
`DISPLAY
`
`
`
`SENDING
`MESSAGE
`I
`OF DATA
`
`ACTION NOT
`
`
`COME?“
`COMPLETE"
`
`
`
`
`
`
`YES
`
`RETURN TO
`MODEM
`
`
`
`
`
`
`
`USER INPUTS
`RETURN OR
`CANCEL
`
`2030
`
`
`
`
`RETRIEVE
`
`
`USER
`
`
`
`LABEL DATA,
`
`SELECTION=
`INSERT IN
`
`
`FAX FORMAT
`
`
`
`2060
`
`SEND FM
`FORMATTED
`DATA TO
`MODEM
`
`2065
`
`DISPLAY
`“SENDING DATA”
`MESSAGE AND
`SCROLL BAR
`
`FORMAT
`
`
`RETRIEVE DATA
`FROM MEMORY
`
`BUFFER INSERT
`IN FAX FORMAT
`
`
`
`
`RETRIEVE DATE,
`INSERT IN FAX
`
`
`
`FIG.20
`
`18
`
`18
`
`

`

`US. Patent
`
`Jul. 2, 2002
`
`Sheet 18 0f 20
`
`US 6,415,166 B1
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` START TO HOST
`
`SYSTEM
`
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`SUBROUTINE
`
`DISPLAY MESSAGE
`
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`"DIAL HOST
`SYSTEM, AFTER
`
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`TONES ARE HEARD
`PRESS RETURN”
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`2120
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`2130
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`USER INPUTS
`RETURN OR
`CANCEL
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`RETRIEVE LABEL DATA
`INSERT IN ASCII FORMAT
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`RETRIEVE DATA FROM
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`MEMORY BUFFER, INSERT
`IN ASCII FORMAT
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`2145
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`2150
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`USER
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`RET’EJRN
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`CAN7CEL
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`DISPLAY
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`NO
`MESSAGE
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`DISPLAY “SENDING DATA”
`COMPLET
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`MESSAGE AND SCROLL
`COMPLETE
`?
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` BAR
` RETURN
`TO MODEM
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`RETRIEVE DATE, INSERT
`IN ASCII FORMAT
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`SEND ASCII FORMATTED
`DATA TO MODEM
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`2160
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`2165
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`FIG.21
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`US. Patent
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`Jul. 2, 2002
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`Sheet 19 0f 20
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`US 6,415,166 B1
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` TART WAIT F0 '
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`CALL
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`SUBROUTINE
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`DISPLAY MESSAGE
`“WAIT FOR CALL"
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`USER INPUTS
`CANCEL OR NO
`INPUT
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`2245
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`YE s
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`SELECTION:
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`2250
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`2255
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`CAN?CEL
` USER
`RETRIEVE LABEL DATA
`INSERT IN ASCII FORMAT
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`RETRIEVE DATA FROM
`
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`MEMORY BUFFER INSERT
`IN ASCII FORMAT
` 2280 2260
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`RETRIEVE DATE, INSERT
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`IN ASCII FORMAT
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`SENDING
`NO
`NIEIS'SIAIOYE
`
`OF DATA
`ACTION NOT
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`
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`COMSLET. COMPLETE”
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`I.
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`SEND ASCII FORMATTED
`DATA TO MODEM
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`2265
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`2270
`DISPLAY “SENDING DATA”
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`MESSAGEBAAIIIRD SCROLL
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`RETURN
`TO MODEM
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`
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`FIG.22
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`20
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`US. Patent
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`Jul. 2, 2002
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`Sheet 20 0f 20
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`US 6,415,166 B1
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`
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`SELECTION
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`USER
`SELECTION=
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`REAL
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`TIME
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`GET TIME
`INTERVAL AND
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`MODE
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` USER ENTERS
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`USER
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`SELECTION:
`TREND
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`
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`SELECT DATA
`SUBROUTINE
`FIG.18
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`
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`STOP REAL TIME
`PRINTING
`
`FORMAT DATA AND
`SEND TO PRINT
`MECHANISM
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`
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`USER
`CURRENTL
`PRINTING
`SELECTION:
`
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`REAL
`SUMMATIO
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`TIME
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`2380
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`USER
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`SELECTION:
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`STOP
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`STOP PRINTING
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`FIG.23
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`21
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`21
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`

`

`US 6,415,166 B1
`
`1
`PHOTOPLETHYSMOGRAPHIC DEVICE
`WITH REMOTE FACSIMILE
`
`CROSS REFERENCE TO RELATED
`APPLICATION
`
`This application is a continuation-in-part of application
`Ser. No. 08/938,224, filed on Sep. 26, 1997, and titled
`“PHOTOPLETHYSMOGRAPHIC DEVICE WITH
`REMOTE FACSIMILE”, now abandoned, which is incor-
`porated herein by reference in its entirety.
`FIELD OF THE INVENTION
`
`This invention relates to the collection and transmission
`
`of data in medical monitoring equipment and, in particular,
`to the collection, selection, arrangement, formatting, and
`transmission of data in photoplethysmographic systems
`which relate to the concentrations of certain blood analyte
`levels of a patient.
`BACKGROUND OF THE INVENTION
`
`is a problem in the field of monitoring systems to
`It
`transmit photoplethysmographic monitoring data to a
`physician, hospital, or other care giver from a remote
`location using only the hardware associated with the stan-
`dard photoplethysmographic devices. To date no photopl-
`ethysmographic monitors exist which are capable of pre-
`formatting the data collected and blood analyte
`measurements generated by a photoplethysmographic moni-
`tor.
`
`A facsimile is a digital representation of an image. Data
`and text in a facsimile is not stored as words and letters in
`
`ASCII format, but rather the image of the text, data, graphs,
`etc.
`is stored as a gray-scale bit map. It
`is possible to
`purchase a standard modem for the transmittal of data to a
`remote location. However,
`there is no way to send the
`information directly to a facsimile machine due to the
`special facsimile data format which is required.
`The problems associated with the limitations of standard
`photoplethysmographic systems has led to a number of prior
`art alternatives which have their own limitations and draw-
`backs.
`
`The Medical Data Archiving Corporation (MDAC)
`Oximetry Recording & Reporting System (OxiScanTM) pro-
`vides a method and system for transmission of oximetry data
`via standard telephone lines. The OxiScanTM system requires
`the connection of the photoplethysmographic monitor to a
`processing terminal. Additionally, the output of the process-
`ing terminal is not sent to the ultimate care provider, but
`rather, is directed to the MDAC Reporting Service which
`then sends an oximetry report to a facsimile machine within
`fifteen minutes. The delay caused by the intermediate pro-
`cessing at a second remote location and the possibility of
`error introduced by the additional transmission step reduces
`the usefulness of such a system.
`In most commercial pulse oximeters such as the Ohm-
`eda® 3800 or the Nellcor —3000 there is an RS232 serial
`
`port which may be used to download collected photoplethys-
`mographic data from a pulse oximeter to another computing
`device. However,
`there is presently no photoplethysmo-
`graphic system that enables a user, such as a remote acute
`care provider,
`to convey photoplethysmographic data
`directly from the remote field location to the ultimate care
`provider in the hospital or physician’s office.
`SUMMARY OF THE INVENTION
`
`The above described problems are solved and a technical
`advance achieved in the field by the photoplethysmographic
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`system of the present invention which conveys photopl-
`ethysmographic data to the standard facsimile machine of a
`remote user in a simple, direct, and immediate manner. This
`photoplethysmographic system produces a facsimile data
`format serial output which can be transmitted to the remote
`facsimile via telephone lines via an external modem or via
`a modem internal to the photoplethysmographic monitor.
`Photoplethysmographic data may also be transmitted to a
`remote host system via the internal or external modem. The
`remote host system may also retrieve the data through
`contacting the system of the present
`invention directly.
`Lastly, through an internal printer, photoplethysmographic
`data may be printed out in hard copy form.
`In a preferred embodiment of the invention, a photopl-
`ethysmographic monitoring system provides the facsimile
`data format for oximetry data to an external modem via its
`serial port. In another embodiment of the invention, the
`photoplethysmographic monitor contains the modem inter-
`nally and, therefore, can transmit formatted reports directly
`to the facsimile machine of a remote user without additional
`hardware.
`
`DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a functional block diagram of one embodiment
`of the present
`invention in which the formatted data is
`directed to an external modem or to an internal printer.
`FIG. 2 is a block diagram of the embodiment of FIG. 1
`further depicting functional components of the system of
`FIG. 1.
`
`FIG. 3 is a block diagram of the embodiment of FIG. 1
`further depicting alternative functional components of the
`system of FIG. 1.
`FIG. 4 is a functional block diagram of an alternative
`embodiment of the present invention in which the modem is
`internal to the photoplethysmographic device.
`FIG. 5 is a block diagram of the alternative embodiment
`of FIG. 4 further depicting functional components of the
`system of FIG. 4.
`FIGS. 6A and 6B depict the facsimile report format of a
`device according to an embodiment of the present invention.
`FIG. 7 depicts the internal printer report format of a
`device according to an embodiment of the present invention.
`FIG. 8 depicts the remote host system report format of a
`device according to an embodiment of the present invention.
`FIGS. 9 through 15 depict various user interface screens
`provided in an embodiment of the present invention.
`FIGS. 16 through 23 depict a series of software flow
`diagrams for one embodiment of the present invention.
`
`DETAILED DESCRIPTION
`
`The data collected by a pulse oximeter, which is a type of
`photoplethysmographic monitoring system, is used to gen-
`erate a saturation value for oxygenated hemoglobin (SpOz)
`which is directly related to the oxygen content of the
`patient’s blood, a pulse rate, and a pulsatility value. Other
`types of photoplethysmographic monitors may include
`blood analyte concentrations for carboxyhemoglobin,
`methemoglobin, or other blood analytes.
`In most pulse
`oximeters a number representing the oxygen content of the
`blood of a patient (SpOz) is displayed. A photoplethysmo-
`graphic waveform of the pulsatile variations in the collected
`data over time or trend data over a period of time may also
`be displayed. The pulse of the patient may also be displayed,
`and in certain Ohmeda® pulse oximeters, a Perfusion Index
`22
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`

`US 6,415,166 B1
`
`3
`PITM pulsatility value is displayed. The PITM pulsatility value
`indicates a quantified level of perfusion of the tissue of a
`patient through the inflow of blood into the tissue. All of this
`information is useful to the medical practitioner in deter-
`mining the condition and proper treatment of a patient.
`The present invention enables the user of a photoplethys-
`mographic system to send collected photoplethysmographic
`data from the system to a remotely located facsimile
`machine thereby providing a formatted hard copy printout of
`the photoplethysmographic data without the use of auxiliary
`computing devices, such as a personal computer or central
`monitoring station. Thereby, useful photoplethysmographic
`data, such as SpO2 levels, pulse rates, and pulsatility values
`can be transmitted in a useful format from any location to
`a remotely located medical practitioner using standard
`telecommunications equipment. Data may also be sent
`directly to a remote host system, such as a personal
`computer, through
`the modem, or directly downloaded to a personal com-
`puter through an RS232 interface.
`In addition,
`the
`present invention will automatically answer an incom-
`ing call from a personal computer, and allow the
`personal computer to access the photoplethysmo-
`graphic data. An optional internal printer can provide
`on-demand hard copy output of the collected data.
`The monitoring apparatus described herein as the pre-
`ferred embodiment is a pulse oximeter instrument which
`measures the oxygen saturation of the arterial blood of a
`patient. The pulse oximeter instrument operates by illumi-
`nating the arteriolar bed of a perfused appendage, ear lobe,
`or nasal septum of the patient with light from light sources
`characterized by spectra having distinct center wavelengths.
`The center wavelengths are selected so that the light emitted
`by one light source is highly absorbed by oxygenated
`hemoglobin contained in the arterial blood, while the other
`is selected with respect to its absorbency by deoxygenated
`hemoglobin. The pulse oximeter instrument then measures
`the magnitude of the light that passes through the illumi-
`nated tissue. The pulsatile component of the light output
`from the tissue is used to determine the oxygen saturation of
`the arterial blood flow.
`
`Referring to FIGS. 1 and 2, a probe 20 containing a
`plurality of light sources 9 and 10, such as LED or laser
`diodes, and a photo detector 7 is attached to an appendage
`of the patient, such as a finger 8. The appendage is rich in
`arterial blood flow so that the light transmissivity of the
`arterial blood, and thereby the oxygen saturation thereof, can
`be directly measured. The light sources 9 and 10 and photo
`detector 7 may, alternatively, be placed on the ear lobe or
`nasal septum of the patient. The output signal produced by
`the photo detector 7 is transmitted via cable 6 and is
`processed by the pulse oximeter instrument 30, producing a
`numeric value indicative of the oxygen saturation of the
`arterial blood. It is a collection of these oxygen saturation
`levels (SpO2 levels) over time that is transmitted to a remote
`location or retrieved from a remote location or printed out on
`an internal printer.
`The functional block diagram of the pulse oximeter
`instrument 30 of FIG. 1 provides a description of the internal
`processing necessary to provide a complete facsimile data
`format output to modem 40 and to remote facsimile 70, to
`provide an ASCII data format output to modem 40 and to
`remote host system 80, and to provide an ASCII data format
`output to print mechanism 23.
`Raw input data from probe 20 is converted to a digital
`representation by analog-to-digital converter 37. The digital
`data set representing the output from photo detector 7 of
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`probe 20 is then used by the software internal to the pulse
`oximeter instrument 30 to calculate the SpO2 level of the
`patient’s blood in a well known way. For instance,
`the
`techniques discussed in US. Pat. No. 5,503,148 issued to
`Pologe et. al., hereby incorporated by reference, may be
`used for calculating SpO2 levels.
`The digital data set from the analog-to-digital converter
`37 is used by the SpO2 generator 34 to generate SpO2
`saturation levels at specific time intervals of at least every
`six seconds. The SpO2 saturation levels generated by the
`SpO2 generator 34 are then forwarded to a memory buffer 32
`where a time-tagged series of SpO2 blood saturation values
`is stored for later output to central processing unit 21 and on
`to main memory 36, modem analog/serial
`interface 25,
`output display 27, and printer parallel interface 22, and for
`use by graph generator 33 and statistic and alarm generator
`35. Output display 27 is typically a combination of an LED
`display and an LCD display, but could be one or the other
`only. Photoplethysmographic waveform and trend data are
`easily displayed on the LCD type display. Saturation and
`pulse rate values and alarm indicators are readily displayed
`on the LED type display.
`The SpO2 saturation levels generated by the SpO2 gen-
`erator 34 are forwarded from memory buffer 32 to a statistic
`and alarm generator 35 where a set of statistical character-
`istics for a data set are defined for the buffered set of data.
`
`For example, a histogram may be generated as well as a
`breakdown by range of the amount of time the SpO2 level
`was within certain ranges. Other statistical characteristics
`such as the highest and lowest SpO2 levels and durations for
`each of the high and low levels for a given set of data can
`also be generated by the statistic and alarm generator 35.
`Examples of alarms which can be generated by the statistic
`and alarm generator 35 include “Low SpOz”, “High SpOz”,
`“No Sensor” and “Sensor Off” warnings. These latter two
`warnings are generated by the data emerging from the signal
`quality monitor 38.
`Signal quality monitor 38 receives data from the analog-
`to-digital converter which is indicative of the quality of the
`input data signal. The quality of the signal can be a measure
`of the signal to noise ratio, intensity and/or frequency of
`motion artifacts, or other measure of the credibility of the
`input data, regardless of the signal strength. The signal
`quality monitor 38, in response to the received data, pro-
`duces one of a plurality of drive signals to generate an
`indication of the quality of the input data signal in order to
`determine if an alarm such as “No Sensor” or “Sensor Off”
`
`should be displayed to the user.
`There are other characteristics of the input signal received
`from probe 20 that are of interest to the user of the pulse
`oximeter 30, such as the patients’ pulse rate and pulsatility
`value. Data from analog-to-digital converter 37 is also
`supplied to pulse strobe 39 to provide a time-tagged pulse
`value for the patient which is then stored in memory buffer
`32 for later transfer through central processing unit 21 to
`specific memory locations in main memory 36. The data will
`later be used by modem analog/serial
`interface 25 and
`printer parallel interface 22. The statistic and alarm genera-
`tor 35 also uses the set of pulse values to develop a high and
`low pulse statistic and rate duration as well as high and low
`pulse alarms. Data from analog-to-digital converter 37 is
`also forwarded to a pulsatility value generator 31 where the
`pulsatility value is generated according to one or more
`known methods, including, but not limited to, percent modu-
`lation.
`
`Graph generator 33 provides a bar graph or other graphi-
`cal representation of photoplethysmographic data which can
`23
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`US 6,415,166 B1
`
`5
`then be stored in main memory 36 and formatted for
`transmission to the remote facsimile via modem 40. Internal
`
`clock 26 is used to time-tag data and provide the date of data
`collection,
`the time the data collection began, and the
`duration of the data collection.
`
`the user,
`input 15 provides a mechanism for
`User
`generally, the nurse, home-care aide or physician, to input
`data regarding the patient and the time and date of the
`photoplethysmographic study. Additionally, user input 15
`permits the user to select the duration of the study, to select
`the format of data to be displayed on output display 27, to
`select modem characteristics, and set up pulse oximeter 30
`for transmission of data via modem 40 or in response to
`receiving a call from remote host system 80. User input 15
`may comprise one or more of the following input devices:
`touch-sensitive screen, keyboard,
`touch-pad, mouse,
`trackball, joystick, or axially actuatable rotary dial (for
`example, as disclosed in US. Pat. No. 5,627,531 to Reichert
`et al., and hereby incorporated by reference). In an alternate
`embodiment the user input 15 is external to pulse oximeter
`30 and communicates through the standard R8232 port
`found on most pulse oximeters. In this alternate embodiment
`user input 15 may be a personal computer or some other
`communication device having a user interface and a serial
`communication port.
`Print mechanism 23 can provide on-demand hard copy
`output of the data collected by probe 20 and processed by
`pulse oximeter 30. Printer mechanism 23 is typically a
`thermal single column dot matrix printer. Printer user input
`24 is only active when waveform data or trend data is being
`displayed on output display 27.
`The user may select one of several options with printer
`user input 24. The user may select to print out real time data
`while monitoring the patient. The real time data may be
`printed out in SpO2 format or PITM format in either six
`second or thirty second intervals. Selecting a summation
`option during real time printing immediately stops the real
`time printing. Summary statistics are then printed out
`encompassing all the data that was printed out in real time
`up to the time when the summation option was selected. The
`user may also choose to print trend data over a selected
`period of time. The user can further select to print all the
`trend data over the selected period of time or only summary
`statistics for the selected period of time.
`FIG. 2 depicts a system according to the present invention
`wherein probe 20 is connected to pulse oximeter 30. Upon
`selection of a send fax option, pulse oximeter 30 generates
`data in a facsimile data format which is sent via modem 40
`
`and telephone 50 through a standard telephone jack 60
`through the telecommunication switching network of local
`and/or long distance carriers to remote facsimile 70. Upon
`selection of a send to host system option, pulse oximeter 30
`generates data in an ASCII data format which is sent via
`modem 40 and telephone 50 through a standard telephone
`jack 60 through the telecommunication switching network
`of local and/or long distance carriers to remote host system
`80. Upon selection of a wait for call option, pulse oximeter
`30, when called by remote host system 80, generates data in
`an ASCII data format which is sent via modem 40 and
`
`telephone 50 through a standard telephone jack 60 through
`the telecommunication switching network of local and/or
`long distance carriers to remote host system 80.
`FIG. 3 depicts an additional connection scheme where
`external modem 40 is compatible with cellular communica-
`tion devices for transmission of the data in facsimile data
`format
`to remote facsimile 70 or ASCII data format to
`
`remote host system 80.
`
`It
`
`is also possible to use other
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`telecommunications devices, such as digital PCS
`telephones, or satellite telephony services such as Global-
`star® or Iridium®. Such systems allow the pulse oximeter to
`be used as a portable unit with the ability to provide
`facsimile data format output or ASCII data format output to
`any remote facsimile machine independent of hard-wired
`connections to existing telephone systems.
`FIG. 4 depicts an alternate embodiment of a pulse oxime-
`ter according to the present invention. Probe 20 is connected
`to pulse oximeter 130 which contains essentially identical
`circuitry and software to the above discussed embodiment of
`FIG. 1 including user input 115, central processing unit 121,
`printer interface 122, print mechanism 123, printer user
`input 124, modem analog/serial interface 125, internal clock
`126, output display 127, pulsatility value generator 131,
`memory buffer 132, graph generator 133, SpO2 generator
`134, statistic and alarm generator 135, main memory 136,
`analog-to-digital converter 137, signal quality monitor 138,
`and pulse strobe 139. In this alternate embodiment, however,
`modem 140 is internal
`to pulse oximeter 130,
`thereby
`reducing the number of external boxes and connections
`required for use of the remote facsimile function.
`FIG. 5 is a block diagram of the alternative embodiment
`of FIG. 4 further depicting functional components of the
`system of FIG. 4. Referring now to FIG. 5, pulse oximeter
`130 with an internal modem is connected to the remote
`
`facsimile 70 or the remote host system 80 via telephone 50
`and telephone jack 60.
`FIGS. 6A and 6B depict one embodiment of a facsimile
`report format for photoplethysmographic data for a device
`according to the present invention. Referring now to FIGS.
`6A and 6B, Label Information Field 601 provides up to four
`lines of alphanumeric text, such as patient name, patient
`number, doctor name, and hospital. By And Comments Field
`602 provides up to four lines of alphanumeric text, such as
`clinician name and any relevant comments. Data for Label
`Information Field 601 and By And Comments Field 602 is
`entered either through user input 15 which is internal to
`pulse oximeter 30, or through a personal computer keyboard
`which is in serial communication with pulse oximeter 30.
`Study Start Time Field 603, Study End Time Field 604,
`and Study Duration Field 605 provide the date and time the
`data collection began, the date and time the data collection
`ended, and the duration of the data collection respectively.
`These values are derived from the internal clock 26 of pulse
`oximeter 30, which is also used to time-tag data.
`Statistic and alarm generator 35 is responsible for gener-
`ating the data found in Study Highlights Field 606, which
`includes the lowest SpO2 value for the data printed with a
`corresponding Pulse Rate (PR) and time stamp. The average
`SpO2 value, the SpO2 standard deviation, the high PR rate
`with corresponding SpO2 value and time stamp, the low PR
`rate with corresponding SpO2 value and time stamp, and
`average PR are also reported. The standard deviation rep-
`resents the scatter of the SpO2 data points. A high standard
`deviation represents a wide range of SpO2 values.
`SpO2 Values Below Field 607 shows the total number of
`SpO2 values below the low SpO2 alarm limit. Total Duration
`Below F