throbber
Signal processing algorithms
`
`133
`
`we do a large number of calculations of the Ratio of Ratios for each period, and
`then do the best fit calculation to the line y = Rx + b to fit the optimum value of
`R for that period, taking into account the constant I) which is caused by DC drift.
`To determine the Ratio of Ratios exclusive of the DC offset we do a linear
`regression.
`It
`is preferred to take points along the curve having a large
`differential component, for example, from peak to valley. This will cause the mx
`term to dominate the constant b:
`
`R
`
`: ”Ext-w "2 xii-"'1'
`fl
`,,
`HEIJ“ -(2Ij)"
`
`(9.33)
`
`where n = # of samples,j = sample #, x = IRdIIR /dt, y = IIRdIR /dt.
`Prior sampling methods typically calculate the Ratio of Ratios by sampling
`the combined AC and DC components of the waveform at the peak and valley
`measurements of the waveform. Sampling a large number of points on the
`waveform, using the derivative and performing a linear regression increases the
`accuracy of the Ratio of Ratios, since noise is averaged out. The derivative form
`eliminates the need to calculate the logarithm. Furthermore doing a linear
`regression over the sample points not only eliminates the noise caused by patient
`movement of the oximeter,
`it also decreases waveform noise caused by other
`sources.
`
`9.4 GENERAL PROCESSING STEPS OF OXIMETRY SIGNALS
`
`The determination of the Ratio of Ratios (ROS) requires an accurate measure of
`both the baseline and pulsatile signal components (Frick et al 1989). The baseline
`component approximates the intensity of light received at the detector when only
`the fixed nonpulsatile absorptive component
`is present
`in the finger. This
`component of the signal is relatively constant over short intervals and does not
`vary with nonpulsatile physiological changes, such as movement of the probe.
`Over a relatively long time, this baseline component may vary significantly. The
`magnitude of the baseline component at a given point in time is approximately
`equal to the level identified as RH (figure 9.2). However, for convenience, the
`baseline component may be thought of as the level indicated by RL, with the
`pulsatile component varying between the values of RH and RL over a given pulse.
`Typically, the pulsatile component may be relatively small in comparison to the
`baseline component and is shown out of proportion in figure 9.3. Because the
`pulsatile components are smaller, greater care must be exercised with respect to
`the measurement of these components. If the entire signal, including the baseline
`and the pulsatile components, were amplified and converted to a digital format
`for use by microcomputer, a great deal of the accuracy of the conversion would
`be wasted because a substantial portion of the resolution would be used to
`measure the baseline component (Cheung et al 1989).
`In this process, a substantial portion of the baseline component termed offset
`voltage V05 is subtracted off the input signal V1. The remaining pulsatile
`component is amplified and digitized using an ADC. A digital reconstruction is
`then produced by reversing the process, wherein the digitally provided
`
`information allows the gain to be removed and the offset voltage added back.
`
`_
`'
`
`|
`
`151
`
`151
`
`

`

`
`
`134
`
`Design of pulse oximeters
`
`including the baseline and
`This step is necessary because the entire signal,
`pulsatile components is used in the oxygen saturation measurement process.
`Feedback from the microcomputer is required to maintain the values for
`driver currents IO, V0S and gain A at levels appropriate to produce optimal ADC
`resolution (figure 9.4). Threshold levels L1 and L2 slightly below and above the
`maximum positive and negative excursions L3 and L4 allowable for the ADC
`input are established and monitored by the microcomputer (figure 9.5). When the
`magnitude of the input
`to and output from the ADC exceeds either of the
`thresholds L1 or L2, the drive currents ID are adjusted to increase or decrease
`the intensity of light
`impinging on the detector. This way,
`the ADC is not
`overdriven and the margin between L1 and L3 and between L2 and L4 helps
`assure this even for rapidly varying signals. An operable voltage margin for the
`ADC exists outside of the thresholds, allowing the ADC to continue operating
`while the appropriate feedback adjustments to A and VOS are made. When the
`output from the ADC exceeds the positive and negative thresholds L5 or L6, the
`microcomputer responds by signaling the programmable subtractor to increase or
`decrease the voltage VOS being subtracted. This is accomplished based on the level
`of the signal received from the ADC. Gain control
`is also established by the
`microcomputer in response to the output of the ADC (Cheung at al 1989).
`
`with. + Vos = V1
`A
`V03
`
` Microcomputer
`
`
`
`
`
`Limits
`adj
`
`5 Motion
`';
`artifact
`
`5 Peak
`E detect
`
`Analysis.
`features
`display
`
`
`Figure 9.4. A functional block diagram of the microcomputer feedback illustrating the basic
`operation of the feedback control system. The DC value of the signal is subtracted before digitizing
`the waveform to increase the dynamic range of conversion. The removed DC value is later added to
`the digitized values for further signal processing (Cheung at al 1989).
`
`A program of instructions executed by the Central Processing Unit of the
`microcomputer defines the manner
`in which the microcomputer provides
`servosensor control as well as produces measurements for display. The first
`segment of the software is the interrupt level routine.
`
`9.4.] Start up software.
`
`The interrupt level routine employs a number of subroutines controlling various
`portions of the oximeter. At
`the start up, calibration of
`the oximeter
`is
`
`
`
`152
`
`152
`
`

`

`Signal processing algorithms
`
`[35
`
`performed. After calibration, period zero subroutine is executed which includes
`five states, zero through four (figure 9.6).
`Period zero subroutine is responsible for normal sampling
`
`State 0: Initialize parameters
`State 1: Set drive current
`State 2: Set offsets
`State 3: Set gains
`State 4: Normal data acquisition state.
`
`Probe set-up operations are performed during the states zero to three of this
`subroutine. During these states probe parameters including the amplifier gain A
`and offset voltage V05 are initialized, provided that a finger is present in the
`[.u'obe. State 4 of the intemrpt period zero subroutine is
`the normal data
`acquisition state. The signals produced in response to light at each wavelength are
`then compared with the desired operating ranges
`to determine whether
`modifications of the driver currents and voltage offsets are required. Finally state
`4 of the period zero subroutine updates the displays of the oxirneter. Sequential
`processing returns to state 0 whenever the conditions required for a particular
`state are violated (Cheung at a! 1989).
`
`High rail
`
`L3
`
`
`
`>\\\m L1
`\
`
`
` L6
` L2
`
`L4
`
`
`
`
`
`
`Low rail \\\V
`
`Figure 9.5 A graphical representation of the possible ranges of digitized signal, showing the
`desired response of the I/O circuit and microcomputer at each of the various possible ranges
`(Cheung et al 1989).
`
`9.5 TRANSIENT CONDITIONS
`
`The relative oxygen content of a patient's arterial pulses and the average
`background absorbance remain about the same from pulse to pulse. Therefore.
`the red and infrared light that is transmitted through the pulsatije flow produces a
`regularly modulated waveform with periodic pulses of comparable shape and
`amplitude and a steady state background transmittance. This regularity in shape
`helps in accurate determination of the oxygen saturation of the blood based on the
`maximum and minimum transmittance of the red and infrared light.
`Changes in a patient‘s local blood volume at the probe site due to motion
`artifact or ventilatory artifact affect
`the absorbance of light. These localized
`
`
`
`— 1
`
`53
`
`153
`
`

`

`
`
`changes often introduce artificial pulses into the blood flow causing the periodic
`pulses ride on a background intensity component of transmittance that varies as
`blood volume changes. This background intensity component variation, which is
`not necessarily related to changes in saturation, affects the pulse to pulse
`uniformity of shape, amplitude and expected ratio of the maximum to minimum
`transmittance, and can affect the reliability and accuracy of oxygen saturation
`determination (Stone and Briggs 1992).
`
`Calibration
`at start up
`
`Start up
`
`Other interrupt
`
`penods
`
`
`
`
`
`
`
`States 0 to 3
`to setup probe
`
`sam oles
`
`
`
`Drive LEDs a
`input samples
`
`Check offsets
`
`Update display
`
`
`
`
`
`Figure 9.6. Flow chart of a portion of an interrupt
`microcomputer (Cheung ct al 1989).
`
`lcvc] software routine included in the
`
`In addition, there are times when the patient’s background level of oxygen
`saturation undergoes transient changes, for example, when the patient loses or
`requires oxygen exchange in the lungs while under gaseous anesthesia. The
`transient waveform distorts the pulse shape, amplitude, and the expected ratio of
`the pulses, which in turn affects the reliability and accuracy of the oxygen
`saturation determination.
`
`With changes in the background intensity absorbance component due to
`artifacts from changes in blood volume or
`transient saturation changes,
`the
`determined saturation value is not accurate and it would not become accurate
`again until the average absorbance level stabilizes.
`an
`signals provide
`The
`saturation calculations based upon transient
`overestimation 0r underestimation of the actual saturation value, depending upon
`the trend. The transmittance of red light increases as oxygen saturation increases
`resulting in a signal value having a smaller pulse, and the transmittance of the
`infrared light decreases as saturation increases resulting in the infrared pulsatile
`amplitude increasing. For
`these wavelengths,
`the transmittance changes with
`saturation are linear in the range of clinical
`interest,
`i.e., oxygen saturation
`between 50% and 100%. The accuracy of the estimation is of particular concern
`
`during rapid desaturation. In such a case, the determined saturation based on the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`154
`
`
`136
`Design, of pulse ()ximctcrs
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`154
`
`

`

`
`
`Signal processing algorithms
`
`137
`
`value. This
`actual
`than the
`drop
`a greater
`indicates
`detected signals
`underestimation of oxygen saturation may actuate low limit saturation alarms that
`can result in inappropriate clinical decisions.
`The pulsatile amplitude is usually quite small, typically less than 5% of the
`overall
`intensity change and any small change in overall or background
`transmittance, such as slight changes in average blood saturation, can have a
`relatively large effect on the difference in maximum and minimum intensity of
`the light
`levels. Because the Change in transmittance with changing oxygen
`saturation is opposite in direction for the red and infrared,
`this can result
`in
`overestimation of the pulsatile ratio during periods when saturation is decreasing,
`and underestimation during periods when saturation is increasing. It is therefore
`essential to compensate for the effects of transient conditions and localized blood
`volume changes on the actual
`signal,
`thereby providing a more accurate
`estimation of the actual oxygen saturation value.
`This can be achieved by using a determined rate of change from pulse to
`pulse, using interpolation techniques
`and by using the
`low frequency
`characteristics of the detected signal values.
`The transient error is corrected by linear interpolation where the determined
`maxima and minima for a first and second optical pulses are obtained, the second
`pulse following the first. The respective rates of change in the transmittance due
`to the transient are determined from the maximum transmittance point of the first
`detected pulse to the second detected pulse (Stone and Briggs 1992). The
`determined rates of change are then used to compensate any distortion in the
`detected transmittance of the first detected pulse introduced by the transient in
`accordance with the following algorithm
`
`V
`max(”)
`
`* =
`
`max(”)
`
`+ V
`[ max(n)
`
`—V
`max(”l
`
`“man: (”J ‘ ’mm (”ll
`+l X—-
`)]
`[Imnxln+ll_lmaxl’1)l
`
`(9.34)
`
`where tmax(n) is the time of occurrence of the detected maximum transmittance at
`the n maximum,
`tmin(n) is the time of occurrence of the detected minimum
`transmittance of the wavelength at the n minimum, Vmax(n) is the detected optical
`signal maximum value at the maximum transmittance of the wavelength at the n
`maximum Vmax(n)* is the corrected value, for n being the first optical pulse, and
`n + 1 being the second optical pulse of that wavelength.
`the detected
`By application of the foregoing linear interpolation routine,
`maximum transmittance value at
`tmax(”) can be corrected, using the values
`tm3x(n+l), detected at the next coming pulse, to correspond to the transmittance
`value that would be detected as if the pulse were at steady state conditions. The
`corrected maximum value and the detected (uncorrected) minimum value thus
`provide an adjusted optical pulse maximum and minimum that correspond more
`closely to the actual oxygen saturation in the patient’s blood at
`that time, not
`withstanding the transient condition. Thus, using the adjusted pulse values in place
`of the detected pulse values in the modulation ratio for calculating oxygen
`saturation provides a more accurate measure of oxygen saturation than would
`otherwise be obtained during transient operation.
`Similarly, the respective rates of change in the transmittance are determined
`from the minimum transmittance point of the first detected pulse to the minimum
`of the second detected pulse. The determined rates of change are then used to
`compensate for any distortion in the detected minimum transmittance of the
`
`155
`
`155
`
`

`

`138
`
`Design of pulse oximeters
`
`second detected pulse introduced by the transient
`following algorithm
`
`in accordance with the
`
`v . my”:
`mm
`
`-(n—l)+[V .
`lTlln
`mm
`
`
`Hm“ (n) — ’min (a — 1.)]
`_
`(n) V -
`(n
`1)]><
`[£111in(n)_r|r1|ul”_l)l
`min
`
`(9.35)
`
`where tmaxm) is the time of occurrence of the detected maximum transmittance at
`the n maximum;
`tminm) is the time of occurrence of the detected minimum
`transmittance of the wavelength at the )2 minimum; Vmin(”) is the detected optical
`signal minimum value at the minimum transmittance of the wavelength at the n
`minimum; Vmin(n)* is the corrected value, for n being the second optical pulse,
`and n — 1 being the first optical pulse of that wavelength.
`the detected
`By application of the foregoing linear interpolation routine,
`minimum transmittance value at
`t = n can be compensated using the detected
`values at the preceding pulse 1‘ = n — l, to correspond to the transmittance value
`that would be detected as if the pulse were detected at steady state conditions. The
`compensated minimum value and the detected (uncompensated) maximum value
`thus provide an adjusted optical pulse maximum and minimum that correspond
`more closely to the actual oxygen saturation in the patient’s blood at that time,
`notwithstanding the transient condition. Thus, using the adjusted pulse values in
`place of the detected pulse values in the modulation ratio for calculating oxygen
`saturation provides a more accurate measure of oxygen saturation than would
`otherwise be obtained during transient operation.
`As is apparent from the algorithms, during steady state conditions the
`compensated value is equal
`to the detected value. Therefore,
`the
`linear
`interpolation routine may be applied to the detected signal at all times, rather than
`only when transient conditions are detected. Also, the algorithm may be applied
`to compensate the detected minimum or maximum transmittance values by
`appropriate adjustment of the algorithm terms. The amount of oxygen saturation
`can then be determined from this adjusted optical pulse signal by determining the
`relative maxima and minima as compensated for the respective wavelengths and
`using that
`information in determining the modulation ratios of the known
`Lambert—Beer equation.
`The Nellcor® N—200 oximeter is designed to determine the oxygen saturation
`in one of the two modes.
`In the unintegrated mode the oxygen saturation
`determination is made on the basis of optical pulses in accordance with
`conventional pulse detection techniques. In the ECG synchronization mode the
`determination is based on enhanced periodic data obtained by processing the
`detected optical signal and the ECG waveform of the patient.
`The calculation of saturation is based on detecting maximum and minimum
`transmittance of two or more wavelengths whether the determination is made
`pulse by pulse (the unintegrated mode) or based on an averaged pulse that is
`updated with the occurrence of additional pulses to reflect the patient’s actual
`condition (the ECG synchronized mode).
`incoming
`Interrupt programs control
`the collection and digitization of.
`optical signal data. As particular events occur, various software flags are raised
`which transfer operation to various routines that are called from a main loop
`processing routine.
`The detected optical signal waveform is sampled at a rate of 57 samples per
`second. When the digitized red and infrared signals for a given portion of
`
`156
`
`156
`
`

`

`i
`l
`
`I
`
`Signal processing algorithms
`
`139
`
`detected optical signals are obtained, they are stored in a buffer called DATBUF
`and a software flag indicating lhe presence of data is set. This set flag calls a
`routine called MUNCH, which processes each new digitized optical
`signal
`waveform sample to identify pairs. of maximum and minimum amplitudes
`corresponding to a pulse. The MUNCH routine first queries whether or not there
`is ECG synchronization,
`then the MUNCH routine obtains
`the enhanced
`composite pulse data in the ECG synchronization mode. Otherwise, MUNCH
`obtains the red and infrared optical signal sample stored in DATBUF,
`in the
`unintegrated mode. The determined maximum and minimum pairs are then sent
`to a processing routine for processing the pairs. Preferably,
`conventional
`techniques are used for evaluating whether a detected pulse pair is acceptable for
`processing as an arterial pulse and performing the saturation calculation, whether
`the pulse pair is obtained from the DATBUF or from the enhanced composite
`pulse data.
`The MUNCH routine takes the first incoming pulse data and determines the
`maximum and minimum transmittance for each of the red and infrared detected
`optical signals, and then takes the second incoming pulse data, and determines the
`relative maximum and minimum transmittance. The routine for processing the
`pairs applies the aforementioned algorithm to the first and second pulse data of
`each wavelength. Then the oxygen saturation can be determined using the
`corrected minimum and detected maximum transmittance for the second pulses of
`the red and infrared optical signals. Some of the examples demonstrate the above
`application.
`
`Example 1
`
`Figure 9.7(a) shows the representative plethysmographic waveforms in a steady
`state condition for the red and infrared detected signals. VmaxR(1) equals 1.01 V,
`and VminR(1) equals 1.00 V, for n = l, 2 and 3 pulses. VminR(n) is the detected
`optical signal minimum value at
`the minimum transmittance at
`the n pulse
`minimum. The modulation ratio for the maxima and minima red signal is:
`
`
`VmaXR(n) _ 1.01v
`_
`VminR(n)
`1.00v
`
`=1.01.
`
`For the infrared wavelength, VmaxIR(n) equals 1.01 V and VminIR(n) equals
`1.00 V and the determined modulation ratio is 1.01.
`
`Using these determined modulation ratios in the formula for calculating the
`ratio R provides:
`
`R _ lnl'VnmeJIme R00] _ m _1 00
`1n[VmaXIR(n)/VminIR(n)]
`0.01
`'
`
`A calculated R = 1 corresponds to an actual saturation value of about 81% when
`incorporated into the saturation equation. A saturation of 81% corresponds to a
`healthy patient experiencing a degree of hypoxia for which some corrective
`action would be taken.
`
`* 1
`
`57
`
`157
`
`

`

`140
`
`Design of pulse oximeters
`
`1.010V
`
`1.000V
`
`Red
`
`1 s
`
`2 s
`
`3 s
`
`Steady state saturation
`
`Infrared
`
`2 s
`
`3 s
`
`1.010V
`
`1.000V
`
`1 s
`
`(a)
`
`Decreasing saturation
`
`Vmax3(|Fl)
`
`Vmax2(lR)
`
`Vmax1(R)
`
`
`
`Vmax8(R)
`
`
`
`Vmin3(R)
`
`
`
`
`
`Vmax1(|R)
`
`vmin3(|R)
`
`Vmin2(|R)
`
`(b)
`
`
`
`
`
`Increasing saturation
`
`Vmax3(Fi)
`
`
`
`Vmin1(Fl)
`
`Vmin1(|Fl)
`
`
`(c)
`Vmin2(IR)
`vmin3(IR)
`
`Figure 9.7. Graphical representation of detected optical signals during the steady state and
`transient conditions (Stone and Briggs 1992).
`
`Example 2
`
`Figure 9.7(b) shows the representative plethysmographic waveforms for a patient
`during desaturation or decreasing saturation transient conditions for the red and
`infrared detected signals having optical pulses n = 1, 2, and 3. However, in this
`transient example, it is known at n = 1, that the actual saturation of the patient is
`very close to that during the steady state conditions in example 1. In this transient
`example, the detected values are as follows for both the red and infrared signals:
`
`
`
`158
`
`158
`
`

`

`Signal processing algorithms
`
`141
`
`_________.___——————-—-—
`tmax(1) = 1.0 s
`vmeo) = 1.012 v
`VmuxIRU) = 1.008 V
`rm (1) = 1.2 s
`VminR(l)=1.000V
`vmmIRm) = 1,000V
`1m” (2) = 2.0 s
`vmaxRa) = 1.002 V
`Vmulea) = 1.018 V
`rm (2): 2.2 s
`VminR(2) = 0.990 V
`VminIRa) = 1.010 V
`[max (3) = 3.0 s
`Vmach) = 0.992 V
`meIR(3) = 1.028 V
`1m (3): 3.2 s
`VminR(3) = 0.980 V
`meIRo) = 1.020 V
`
`Calculating the oxygen saturation ratio R at n = 1, using the detected optical
`signal provides the following
`
`R = 1n[VmaxR(1) / VminR(1)]
`1n[VmaxIR(1) / VminIR(l)]
`
`= 1n[1.012 / 1.000] / 1n[1.008 / 1.000]
`
`=1n[1.012]/1n[1.008]
`=0.012/0.008 =15.
`
`The calculated saturation ratio of 1.5 based on the detected transmittance
`corresponds to a calculated oxygen saturation of about 65 for the patient, which
`corresponds to severe hypoxia in an otherwise healthy patient. This contrasts with
`the known saturation of about 81% and demonstrates the magnitude of
`the
`underestimation of the oxygen saturation (overestimation of desaturation) due to
`the distortion in transmittance of the red and infrared light caused by transient
`conditions.
`the distorted maximum
`Applying the correction algorithm to correct
`transmittance point of the detected red signal during the transient condition:
`
`VmaxR(1)* = VmaxR(1)—[VmaxR(1)‘ VmaxR(2)] x
`
`lfmull} — 1.1111111”
`
`“11:31:12) — rIna-110)]
`
`=1.012 - [1.012 — 1.002] X [1.0 -1.2]/[1.0 — 2.0]
`=1.010.
`
`and correspondingly for the maximum transmittance of the detected infrared
`signal
`
`VmaxIR(1)* = 1.008 — [1.008 — 1.018] x [1.0 — 1.2] /[1.0 — 2.0]
`=1.010
`
`Thus, by replacing VmaxR(n) with VmaxR(n)’ and replacing VmaxIR(n) with
`VmaxIROt)a in the calculations for determining the oxygen saturation ratio R, we
`have
`>k
`
`R- 1n[VmaxR(1)
`_
`1n[VmaXIR(1)
`
`>1:
`
`/VmiuR(1)]
`/VminIR(1)]
`
`=1n[1.010/1.00]/1n[1.010/1.00]
`= 001/001
`
`= 1.0.
`
`159
`
`159
`
`

`

`
`
`
`
`142
`
`Design ()fpulse oximeters
`
`Thus, basing the saturation calculations on the corrected maximum transmittance
`values and the detected minimum transmittance values,
`the corrected R value
`corresponds to the same R for the steady state conditions and the actual oxygen
`saturation of the patient.
`
`Example 3
`
`Figure 9.7(c) shows the representative plethysmographic waveforms for a patient
`during desaturation or decreasing saturation transient conditions for the red and
`infrared detected signals having optical pulses n = l, 2 and 3. However,
`in this
`transient example, it is known that at n = 2, the actual saturation of the patient is
`very close to that during the steady state conditions in example 1. In this transient
`example, the detected values are as follows for both the red and infrared signals:
`
`VmHXRU) = 1.022 v—v',—mx1R(1)= 1.002 v
`‘ —lmax(1) = 1.0 s
`
`VminRU) = 1.008 v
`VminIRU) = 0.992 v
`1mm (1) = 1.2 s
`va(2) = 1.012 v
`meIR(2) = 1.012 v
`zmx (2) = 2.0 s
`VminRQ) = 0.998 v
`VminIR(2) = 1.002 v
`1min (2) = 2.2 s
`anxR(3) = 1.002 v
`V,mxIR(3) = 1.022 v
`1mx (3) = 3.0 s
`
`
`VminR(3) = 0.988 v1min(3)= 3.2 s VminIRO) = 1.012 v
`
`Calculating the oxygen saturation ratio R at n = 2, using the detected optical
`signal provides the following
`
`R = 1n[anxR(2) / meR(2)]
`ln[VmaXIR(2) / me IR(2)]
`
`= ln[l.012 / 0.998] / 1n[1.012 / 1.002]
`=0.01393/0.0099 :14.
`
`the calculated saturation ratio of 1.4 based on the detected transmittance
`Thus,
`corresponds to a calculated oxygen saturation of about 51% for the patient, which
`corresponds to severe hypoxia in an otherwise healthy patient. This contrasts with
`the known saturation of about 81% and demonstrates the magnitude of the
`underestimation of the oxygen saturation (overestimation of desaturation) due to
`the distortion in transmittance of the red and infrared light caused by transient
`conditions.
`
`the distorted minimum
`Applying the correction algorithm to correct
`transmittance point of the detected red signal during the transient condition, we
`find the following:
`
`Vmin R(2)* = Vmin R(2) — [Vmin R(Z) — me R(1)] X
`
`[train (2) '- rmax {I i']
`
`= 1.008 — [0.998 — 1.008] X [2.0 —1.2]/[2.2 —1.2]
`= 1.0
`
`and correspondingly for the minimum transmittance of the detected infrared
`optical signal we have:
`
`
`
`160
`
`160
`
`

`

`
`
`Signal processing algorithms
`
`143
`
`VminIR(2)* = 0.992 — [1.002 — 0.992] x 0.8
`= 1.0.
`
`Thus, by replacing VminR(n) with VminR(n)‘ and replacing Vm-mIR(n) with
`Vmian(n)' in the calculations for determining oxygen saturation ratio R we have:
`
`.
`1
`R _ lnlvmnx RUIN Vmin 12(2)
`_ —-_‘——‘_-——Ilr—
`ln[VmaxIR(2)/ VminIR(2)
`]
`
`~4<
`
`= ln[l.012/1.0]/ln[l.012/1.0]
`= 1.0.
`
`Thus, basing the saturation calculations on the corrected minimum transmittance
`values and the detected maximum transmittance values, the corrected R value
`corresponds to the same R for the steady state conditions and the actual oxygen
`saturation of the patient.
`
`9.6 ECG SYNCHRONIZATION ALGORITHMS
`
`Electrical heart activity occurs simultaneously with the heartbeat and can be
`monitored externally and characterized by the electrocardiogram waveform. The
`ECG waveform comprises a complex waveform having several components that
`correspond to electrical heart activity of which the QRS component relates to
`ventricular heart contraction. The R wave portion of the QRS component
`is
`typically the steepest wave therein having the largest amplitude and slope, and
`may be used for indicating the onset of cardiac activity. The arterial blood pulse
`flows mechanically and its appearance in any part of the body typically follows
`the R wave of the electrical heart activity by a determinable period of time. This
`fact
`is utilized in commercially available pulse oximeters to enhance their
`performance. Another advantage of
`recording ECG is
`that
`it provides a
`redundancy in calculating the heart rate from both the ECG signal and the optical
`signal to continuously monitor the patient even if one of the signals is lost (figure
`9.8).
`
`With ECG synchronization, the pulse oximeter uses the electrocardiographic
`(ECG) QRS complex as a timing indicator that the optical pulse will soon appear
`at the probe site. The R portion of the ECG signal is detected and the time delay
`by which an arterial pulse follows the R wave is determined to establish a time
`window an arterial pulse is to be expected. By using the QRS complex to time the
`oximeter’s analysis of the optical pulse signal, ECG processing synchronizes the
`analysis of oxygen saturation and pulse rate data. The established time window
`provides the oximeter with a parameter enabling the oximeter to analyze the
`blood flow only when it is likely to have a pulse present for analysis. This method
`of signal processing passes those components of the signal that are coupled to the
`ECG (i.e.,
`the peripheral pulse), while attenuating those components that are
`random with respect
`to the ECG (e.g., motion artifact or other noise in the
`signal).
`
`161
`
`161
`
`

`

`144
`
`Design of pulse oximetcrs
`
`ECG
`electrodes
`
`ECG
`amiifie
`
`R-wave
`
`
`detection
`
`
`Satu ration
`
`caiculation
`
`
`Ensemble
`Optical pulse
`
`
`processing
`averaging
`
`routine
`circuitry
`
`
`
`
`
`
`
`Digital
`display
`
`Figure 9.8. Block diagram illustrating the ECG processing components, its subcomponents and
`their relationship in an oximeter.
`
`9. 6. I Nellcorw system
`
`C—LOCK ECG synchronization enhances the signal-precessing capabilities of
`Nellcor'y systems such as the N300 pulse oximeter and the N—lUOf) multifunction
`monitor. This improves tltc quality of the optical signal in certain clinical settings
`in which the performance of a conventional pulse oximeter may deteriorate, e.g.
`when a patient is moving or has poor peripheral pulses. Consequently. C~LOCK
`signal processing extends the range of clinical situations in which pulse oximetry
`may be used. Patient movement and poor peripheral pulses present similar
`problems
`for a conventional pulse oximeter: performance may deteriorate-
`because the oximeter is unable to distinguish between the true optical pulse signal
`and background noise. C-LOCK ECG synchronization improves signal quality in
`these difficult signal-detection settings (Goodman and Core-omen 19901
`The digital optical signal is processed by the microprocessor of the Nellcor
`N—IOOO Pulse Oximeter in order
`to identify individual optical pulses and to
`compute the oxygen saturation from the ratio of maximum and minimum pulse
`levels as seen by the red wavelength compared to the pulse seen by the infrared
`wavelength.
`Noninvasive pulse oximeters process optical signals which are prone to
`motion artifacts caused by the muscle movement proximate to the probe site. The
`spurious pulses induced in the optical signals may cause the pulse oximeter to
`process the artifact waveform and provide erroneous data. This problem is
`particularly significant with infants, fetuses, or patients that do not remain still
`during monitoring. Another problem exists in circumstances where the patient is
`in poor condition and the pulse strength is very Weak. In continuously processing
`the optical data, it can be difficult to separate the true pulsatile component from
`the artifact pulses and noise because of low signal
`to noise ratio.
`Inability to
`reliably detect the pulsatiie component in the pulsatile signal may result in a lack
`of the information needed to calculate oxygen blood saturation.
`By incorporating the patient‘s heart activity into the pulse oximeter,
`problems clue to motion artifact and low signalvto—noise ratio can be solved.
`Processing of the signals that occur during a period of time when the optical
`pulses are expected to be found. increases the likelihood that the oximeter will
`process only optical waveforms that contain the pulsatile component of arterial
`blood, and will not process spurious signals.
`
`_ 1
`
`62
`
`162
`
`

`

`Signal processing algorithms
`
`145
`
`The software incorporated into the microprocessor for processing the ECG
`signals and displaying the calculated ECG pulse rate receives the digitized version
`of diagnostic ECG signal
`(DECG) and filtered ECG signals (FECG). The
`microprocessor calculates the amplitude of the ECG waveform and controls the
`AGC (automatic gain control) amplifier, so that DECG and FECG will fall within
`the voltage range limits of the electronic circuitry used to process these signals.
`The microprocessor regularly searches a status input latch at a rate of 57
`cycles per second. The output of detected R wave (DRW) sets the latch to a
`logical
`1 when the R wave is detected. Depending on the
`status,
`the
`microprocessor selects the next operation and resets the DRW latch to 0. At this
`first
`level,
`the microprocessor counts the time interval beginning from the
`detection of an R wave pulse until the occurrence of the next logical
`l at the
`status input latch. Based on this time interval,
`the pulse oximeter displays the
`pulse rate. After averaging several time intervals and establishing a regular ECG
`pulse rate, the microprocessor will change to the second level of processing.
`After
`the detection of an R wave pulse,
`the microprocessor
`separately
`analyzes the digital optical signal and correlates the period of time by which an
`optical pulse follows the detected R wave pulse to establish the time window
`during which the optical pulse is likely to occur. During this second level,
`the
`pulse oximeter just calculates and displays the time period or pulse rate between
`DRW pulses.
`The third level of processing starts after a time window has been established.
`On detecting an R wave pulse, the microprocessor activates the time window so
`that only optical
`signals detected within the time window following the
`occurrence of an R wave pulse will be evaluated for acceptance or rejection and
`for use in calculating and displaying vital measurements
`such as oxygen
`saturation, pulse flow, and pulse rate. The evaluation of a detected pulse is made
`in conjunction with a preselected confidence factor that is associated with the
`quality of the optical signals. The higher the op

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket