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`Schifigraben 41
`D-30175 Hannover, Germany
`Authorized Brazil Company Representative:
`MEDSTAR IMPORT AND EXPORTEIRELI
`R VALENCIO SOARES RODRIGUES,89- ROOM 1
`CEP: 06.730-000
`NEIGHBORHOOD: CENTER
`MUNICIPALITY: VARGEM GRANDE PAULISTA
`UF: SP
`
`Covered by one or more of the following U.S patents: 5482036, 5490505, 5632272, 5685299, 5758644,
`5769785, 5919134, 6002952, 6011986, 6067462, 6157850, 6229856, 6236872, 6263222, 6360114, 6388240,
`6430525, 6463311, 6501975, 6515273, 6606511, 6643530, 6650917, 6654624, 6684090, 6699194, 67450680,
`6816741, 6826419, 6850787, 6861639, 6979812, 7186966, 7215984, 7215986, 7221971, 7254433, 7295866,
`7328053, 7373194, 7376453, 7377899, 7467002, 7469157, 7471969, 7489958, 7496393, 7499741, 7509154,
`7530955, RE38476, RE38492,international equivalents, or one or more of the patents referenced at www.
`masimo.com/patents.htm. Other patents pending.
`© 2018 Masimo Corporation. Masimo, 4 , SET, Rad, LNCS, LNOP. Signal IQ,Discrete Saturation Transform,
`DST, Rainbow, SpCO,SpMet, SpHb and FastSatare registered trademarks of Masimo Corporation.
`Rad-57, SIQ, LNOPv, SpOC, Pulse CO-Oximeter and APODaretrademarks of Masimo Corporation.
`
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`flammable substance in combination with air, oxygen-enriched environments,or nitrous oxide.
`Electric shock hazard. Do not open the Rac-57 cover except to replace the batteries. Only a
`Qualified operator may perform maintenance procedures specifically described in this manual.
`Refer servicing to Masimofor repair of this equipment.
`Highintensity extreme lights (such as pulsating strobe lights and direct sunlight) directed on the
`sensor, may not allow the Ract57to obtain readings.
`EMIradiation interference such as computerdisplays and/or LCD/plasma TVs can cause
`errors or incorrect measurements on the Rad-57.
`
`A Ract57 should be considered an early warning. For measurements of high or low SpHb
`readings, blood samples should be analyzed by laboratory instruments to completely
`understand the patient's condition.
`If patient hypoxemia is indicated, blood samples should be analyzed by laboratory devices to
`completely understand the patient's condition.
`Pulse rate measurementis based on the optical detection of a peripheralflow pulse and therefore
`may not detect certain arrhythmias. The Rac-57 should not be used as a replacementor
`substitute for ECG based arrhythmia analysis.
`As with all medical equipment, carefully route patient cabling to reduce the possibility of patient
`entanglementor strangulation.
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`Do not place containers containing liquids on or near the Rad-57. Liquids spilled on the instrument
`may causeit to perform inaccurately orfail.
`Changes or modifications not expressly approved by the party responsible for compliance could void
`the user's authority to operate the equipment
`
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` SpO is empirically calibrated to functional arterial oxygen saturation in healthy adult
`
`volunteers with normallevels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). The
`Rad-57 cannot measure elevated levels of COHb or MetHb.Increasesin either COHb or MetHb
`will affect the accuracy of the SpO> measurement.
`Inaccurate SpO> readings can be caused by:
`Elevated levels of COHb and MetHb
`
`
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`L Forincreased COHb: COHb levels above normaltend to increasethe level of SpOx. The
`levelof increase is approximately equal to the amount of COHb that is present.
`O NOTE: High levels of COHb mayoccur with a seemingly normal SpO». Whenelevated levels of
`COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.
`
`Forincreased MetHb: the SpO» may be decreasedbylevels of MetHb of up to approximately
`10%to 15%. At higherlevels of MetHb, the SpO» may tend to readin the low to mid 80s.
`Whenelevated levels of MetHb are suspected,laboratory analysis (CO-Oximetry) of a blood
`sample should be performed.
`
`__Intravascular dyes such as indocyanine green or methylene blue
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`naccurate SpCO and SpMetreadings can be caused by:
`
`Elevatedlevels ofbilirubin
`
`
`Motion artifact
`
`
`
`Low arterial oxygen saturation levels including altitude induced hypoxemia
`Do not place the Rad-57 against a surface. This can cause the system or battery (nonclinical)
`alarm to be muffled.
`
`the Rad-57 fails any part of the setup procedures remove the instrument from operation
`until qualified service personnel have corrected the situation.
`Use the Rad-57 in accordance with Section 7, Environmental Specifications in of this
`manual.
`Do notincinerate batteries.
`
` f
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` Te protect againstinjury from electric shock,follow the directions below:
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`Avoid placing the device on surfaces withvisible liquid spills.
`Do not soak or immerse the device in liquids.
`Use cleanings solutions sparingly.
`
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`Cleared Use Only: The device and related accessories are cleared by the Food and Drug
`Administration (FDA)for noninvasive patient monitoring and may not be used for any processes,
`procedures, experiments or any other use for which the device is notintended or cleared by
`the FDA,or in any mannerinconsistent with the instructions for use or labeling. The device and
`related accessories are notintendedfor use in combination with other medical devices orin high-
`risk applications.
`Disposal of product - Comply with locallawsin the disposalof the instrument and/orits
`accessories.
`
`This Class B digital apparatus complies with Canadian ICES-003.
`
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`INTOCUCTION oe eeceeseesteseceeseeetcrsecnsensentensntensateaes
`
`Rad-57 Front PanelControls
`
`Rad-57 Rear Panel..
`
`
`Battery Installation
`Symbols...
`SECTION 3 - SETUP
`INMOGUCLION 0... eetects
`
`
`Unpacking andInspection
`Preparation for Monitoring ......... eee
`
`Monitor Setup ....
`
`Initial Setup...
`SECTION 4 - OPERATION
`Introduction...
`
`Basic Operation .
`General Setup and Use...ccs
`
`Default Settings...
`
`Introduction.......
`
`Basic Operation.
`General Setup and Use... eccrine
`
`Connect a Compatisle Successful SpO. Monitoring
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
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`Special Menu - LineFrequency COnfiQuration......ssssesssesssessessntersesnenss
`
`Trend Setup and Use.......
`
`Introduction...
`
`TrendCom Utility Installation...
`Erasing Trend Memory...
`
`Trend Data Format.........
`SECTION 5 - ALARMS AND MESSAGES
`Alarm Indication.............
`
`Alarm Limits.........
`
`Alarm Silence...
`
`Alarm Silenced Indicator...
`
`MeSSage@S oo... ccceeeeseenees
`SECTION 6 - TROUBLESHOOTING
`TROUDIESHOOTING.........cseeesees
`SECTION 7 - SPECIFICATIONS
`Rad-57 Specifications......
`
`Performance...
`
`Electrical.........
`Environmental...
`
`
`Physical Characteristics .
`
`vi
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`Performance Verification...
`
`Power-OnSelf-Test......
`
`Key Press Button Test.
`
`Alarm Limit Test...
`
`LED Brightness...
`
`Service and Repair...
`
`Repair Policy........
`Return Procedure...
`
`Sales & End-user License AQre@Ment...
`Warranly........
`
`Exclusions...
`
`End-UserLicense....
`Restrictions...
`
`
`SECTION 10- ACCESSORIES
`ACCOSSOLIOS. ...escecceseenscccsceccsnesessceaeeneaeenteneeataneateateatensneenseutentecensensensameasaeeateatenteseateaneaneasanententins 10-1
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`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
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`SECTION 10 Accessories
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
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`NOTE: This is a sampleof a Note.
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` Adjustable averaging 2 to 16 seconds
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`Visual battery life indicator
`Audible Alarm for sensor-off and low battery
`Alarms for SpO,, PR, SpCO* and SpMet* SpHb*, PVI*
`FastSat® (for SpO, measurement)
`Three sensitivity levels - Max, Normal and APOD"(for SpO, measurement)
`72 hours of trending memory
`Adjustable alarm volume
`
`* available in upgraded Instrument
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
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`collects signal data from the patient and sendsit to the instrument. The instrumentdisplays the calculated
`data as measurementof total hemoglobin concentration.
`
`Total Arterial Oxygen Content (CaO5) General Description’
`Oxygen (Op) is carried in the blood in two forms, either dissolved in plasma or combined with
`hemoglobin. The amount of oxygen in the arterial blood is termed the oxygen content (CaO») and
`is measured in units of ml Op/dl blood. One gram of hemoglobin (Hb) can carry 1.34 ml of oxygen,
`whereas 100 ml of blood plasma carries approximately 0.3 ml of oxygen. The oxygen content is
`determined mathematically as:
`CaQ5 = 1.34 (ml Oo/g Hb) x Hb(g/dl) x HbO> + PaO(rm Hg)x (0.3 ml Oo/ 100 mm Hg/al)
`Where HbOsis the fractional functional arterial oxygen saturation and PaQsis the partial pressure
`of arterial oxygen.
`Fortypical PaO> values, the secondpart of the above equation [PaQ> (mm Hg)x (0.3 ml Oo/ 100 mm
`Hg/dl)] is approximately 0.3 mi/dl. Furthermore, for typical carboxyhemoglobin and methemoglobin
`levels,the functional saturation (SpO») as measured by a pulse oximeteris given by:
`SpO, = 1.02 x HbO,
`*Martin, Laurence. All You Really Need to Know to Interpret Arterial Blood Gases, Second Edition. New York: Lip-
`pincott Williams & Wilkins, 1999.
`
`Rad-87 Signal Extraction Pulse CQ-Oximeter Operator's Manual
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`the calculated data as percentage value for the SpMet.
`
`Pleth Variability Index - (PVI) General Description
`The Pleth Variability Index (PVI) is a measure of the dynamic changesin the perfusion index (PI) that
`occur during the respiratory cycle. The calculation is accomplished by measuring changes in PI over
`a time interval where one or more complete respiratory cycles have occurred. PVIis displayed as a
`percentage (0-100%).
`Low Perfusion
`
`It has been suggested that at extremely low perfusion levels, Pulse CO-Oximeters can measure
`peripheral saturation, which may differ from central arterial saturation. This “localized hypoxemia” may
`result from the metabolic demands of other tissues extracting oxygen proximal to the measurement
`site under conditions of sustained peripheral hypoperfusion. (This may occur even with a pulse rate that
`correlates with the ECG heart rate.)
`CAUTION:
`IF LOW PERFUSION IS FREQUENTLY INDICATED, FIND A BETTER-PERFUSED MONITORING
`SITE. INTHE INTERIM, ASSESS THE PATIENT AND,IF INDICATED, VERIFY OXYGENATION
`STATUS THROUGH OTHER MEANS.
`
`1-6
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`Rad-57 utilizes a sensor with variouslight-emitting diodes (LEDs) that pass light through the site
`to a photodiode (detector). See figure below. Signal data is obtained by passing various visible and
`infrared lights (LED's, 500 to 1000nm) through a capillary bed (for example, a fingertip, a hand, a
`foot) and measuring changesin light absorption during the blood pulsatile cycle. This information
`may be useful to clinicians. The maximum radiant power of the strongestlight is rated at < 25mW.
`The detector receives the light, converts it into an electronic signal and sends it to the Rad-57 for
`calculation.
`
`1
`Oo 1.
`
`
`
`Light Emitting Diodes (LEDs)
`(7 + wavelengths)
`2. Detector
`
`Once the Rad-57receives the signal from the sensor, it utilizes Masimo Rainbow SET signal extraction
`technology to calculate the patient's functional oxygen saturation (%SpO,),
`total hemoglobin
`concentration (SpHb [g/dl]), blood levels of carboxyhemoglobin (SpCO*), methemoglobin (SpMet*)
`and pulse rate. The SpHb, SpCO and SpMet measurements rely on a multiwavelength calibration
`equation to quantify the percentage of: total hemoglobin, carbon monoxide or methemoglobin in
`arterial blood. The maximum of the skin surface temperature ig measured at an ambient temperature
`of less than 106° F (41° C). Thisis verified by Masimo sensor skin temperature test procedures.
`“available in upgraded Instrument
`
`1-8
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`Masimo Signal Extraction Technology's signal processing ditfers from conventional pulse oximeters.
`Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in
`the measurementsite. During patient motion, however, the non-arterial blood also moves, causing
`conventional pulse oximeters to read low values, because they cannotdistinguish betweenthe arterial
`and venous blood movement (sometimesreferred to as noise). Masimo SET pulse oximetry utilizes
`parallel engines and adaptive digitalfiltering. Acaptive filters are powertul because they are able to
`adaptto the varying physiologic signals and/or noise and separate them by looking at the whole signal
`and breaking it downto its fundamental components. The Masimo SET signal processing algorithm,
`Discrete Saturation Transform® (DST)®,reliably identifies the noise, isolates it and, using adaptive
`fitters, cancels it. It then reports the true arterial oxygen saturation for display on the monitor.
`
`SpMet, SpCO and SpHb Measurements During Patient Motion
`The Rac-57 displays measurements of SpCO*, SpMet* and SpHb* during patient motion. However,
`because of the changes in the physiological parameters such as blood volume, arterial-venous
`coupling, etc. that occur during patient motion, the accuracy of such measurements maynot bereliable
`during excessive motion. When the Rad-57 does not have confidencein the value of a parameter due
`to poor signal quality caused by excessive motionor othersignalinterference, the Low Signal |Q (Low
`SIQ) LED will flash.
`‘available in upgraded Instrument
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
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`Masimo SET DsT®
`
`
`
` Power AdaptiveFilter
`
`
` Reference
`
`
`Generator
`te
`=H
`
`Output
`
` Signal
`
`Trial Saturation
`
`SpOs
`95%
`
`o
`4
`e
`
`30
`40
`50
`60
`70
`80
`90 95 100
`
`()—gpo, te)
`
`1-10
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`at
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`The Signal |Q provides anindication of the quality of the acquired signal
`as well as the timing of the pulse. A green vertical LED barrises and
`falls with the pulse, where the height of the bar indicates the quality of
`the signal.
`
`
`SIO Bar
`
`Press to display the parameters/measurements selected in the Setup
`Display Button
`Menu screens. Refer to Chapter 4, Setup Menu Level 5 for the options.
`
`
`Enter Button
`
`Used to enter the setup menus and to select/activate certain entries
`within the menu/setup system.
`
`
`O18|2|e|©|e
`
`Used within the menu/setup system to move through setup options. Not
`active when default screen displays.
`
`Pressto turn the Instrument on.
`Power On/Off
`Press-and-hold for 2 seconds to turn the Instrumentoff.
`
`Next Button
`
`Battery Level
`Indicator
`
`. Four LED's indicate the status of the battery. Whenthefinal indicator
`begins flashing, replace the batteries
`
`2-2
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`the oximeter
`
`Lecated on back of Instrument
`Press down andslide the battery coveroff the bottom of
`
`@) Battery Cover
`@ Battery Cover Release
`y
`
`Battery Installation
`The Rad-57 is powered by 4 AA alkaline batteries. Do not use any other type of batteries or
`power source to run the instrument. The battery compartment is accessed from the back of
`the instrument. To install the batteries first remove the battery cover by depressing the small
`rectangular button at the bottom of the cover, and sliding the cover downoff the bottom of the
`instrument.
`Install the batteries in the directions indicated by the battery icons inside the battery
`compartment. Replace the battery coverby sliding it back up from the bottom of the instrument
`until the rectangular locking button snaps backinto position.
`
`WARNING: USE ONLY ALKALINE BATTERIES. USE OF NON ALKALINE BATTERIES MAY
`AFFECT THE ACCURACY OF THE BATTERY LEVEL METER.
`
`WARNING: USE OF BATTERIES WITH A CELL VOLTAGE OF MORE THAN 1.5V¥ COULD
`
`CAUSE DAMAGE TO THE RAD-57.
`
`Battery chargelevelis indicated by four LED indicators at the bottom of the front panel. All four
`indicators will be lit when the batteries are full, with fewer indicators beinglit as the batteries lose
`their charge. When the batterylife is low, the battery indicator will begin to flash and an audible
`
`———alarmwillsound,
`oa
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`Date of manufacture YYYY-MM-DD
`
`
`Warning,electricity
`
`No parameteralarms
`
` ‘
`
`Product contains no PVC (polyvinyl chloride)
`rmaterial
`Electrostatic
`
`
`Notfor Continuous Monitoring
`Catalogue number (model number)
`(No Alarm for $902}
`
`
`Caution
`
`Masimoreference number
`
`Not made with natural rubber latex
`
`Serial number
`
`
`
`Manufacturer
`
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`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`
`
`IrisConnection
`
`> Greaterthan
`
`off
`
`Ethernet
`
`< Less than
`
`© ChinaRestrictionofHazardousSubstances
`
`The namesand content ofthe toxicandhazardous
`e&,
`0) substancesorelementsshall be provided inthe i Recyclable
`product instruction manual.
`
`s3 Instructions/DirectionsforUse/Manualsareavailableinelectronicformat
`
`@ http://www.Masimo.com/TechDocs
`Note: elFU isnot available for CE mark countries.
`
`2-6
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operators Manual
`
`PAGE 28 OF 76
`
`MASITC_01077437
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`A A
`
`
`
`y USBport
`
`
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
`
`31
`
`PAGE 29 OF 76
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`MASITC_01077438
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`MASIMO2005
`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`3-2
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
`
`PAGE 30 OF 76
`
`MASITC_01077439
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`MASIMO2005
`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`
`
`
`Verify all front-panel indicators momentarily illuminate and an audible tone is heard
`Verify the front-paneldisplay is free of alarm and system failure messages (see Section 5,
`Alarms and Messages) and the battery indicator shows sufficient charge (see Section 4,
`Battery LevelIndicator).
`Verify that the display shows the Instrument's enabled parameter/measurement settings in the
`
`following order:
`
`
`SpOp Low Alarm Limit
`
`
`SpOp High Alarm Limit
`
`PR Low Alarm Limit
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PR High Alarm Limit
`SpCO Low Alarm Limit*
`SpCO High Alarm Limit*
`SpMet Low Alarm Limit*
`SpMet High Alarm Limit*
`SpHb Low Alarm Limit*
`SpHb High Alarm Limit*
`PVI Low Alarm Limit*
`
`PVI High Alarm Limit*
`PI Low Alarm Limit*
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
`
`41
`
`PAGE 31 OF 76
`
`MASITC_01077440
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`MASIMO2005
`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`
`
`13.
`
`14.
`
`15.
`
`16.
`17.
`
`42
`
`
`To begin patient monitoring:
`
`
`Adjust the alarm limits.
`
`Adjust the alarm volume.
`
`Adjust the pulse beep volume.
`Verify the sensoris applied correctly and that the measured data is appropriate, see Section 4,
`Successful SpO, Monitoring.
`lonitor the patient.
`After monitoring is complete, remove the sensor from the patient and store or dispose of the
`sensor according to governing rules. See the Directions for Use of the sensor.
`18.
`Press and hold the Power On/Off button for 2 seconds to turn the oximeteroff.
`“available in upgraded Instrument
`
`ing a patient when the sensor was disconnected.
`
`Verify parameter/measurementviolation alarm silence operation.
`
`
`
`
`
`
`
`
`
`Create an alarm condition by lowering the SpO, or pulse rate high alarm limits beyond the
`patient readings.
`Press the Alarm Silence button.
`The alarm tone ceases for 120 seconds.
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operators Manual
`
`MASITC_01077441
`
`PAGE 32 OF 76
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`MASIMO2005
`Apple v. Masimo
`IPR2022-01300
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`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
` Yes/No
`
`
`
`
`
`
`
`PVI* low alarm limit
`Default is "---" Off}
`Set to Pre-Power DownSetting
`
`PV" high alarm limit
`Default is *---" Off
`See Section 5, Alarm Limits forall settings.
`
`
`
`
`
`Set to Pre-Power Down Setting
`Default is *---" Off)
`PI low alarm limit
`See Section 5, Alarm Limits forall settings.
`PI high alarm limit s"---" Off}(Default 0.04 to 19 then "---"
`
`Set to Pre-Power Down Setting
`itivit
`Default is N
`|
`
`Sensitivity faults Normal)|Normal, Maximum (HI) or APOD
`
`on
`.
`Set to Pre-Power Down Setting
`Averaging Time
`Default is 8 seconds)
`
`2, 4, 8, 10, 12, 14, or 16 seconds
`Set to Pre-Power DownSetting
`OfffOn
`Set to Pre-Power Down Setting
`OfffOn
`Setti
`Set to Pre-P
`Coun eng
`one Hrerower
`Venous,Arterial
`Set to Pre-Power DownSetting
`Display Low SIQ Readings|(Default is No)
`
`FastSat
`
`Smartlone
`
`.
`Default is Off)
`
`.
`Default is Off)
`
`SpHb Calibration
`
`(Default is Venous)
`
`Down
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
`
`43
`
`PAGE 33 OF 76
`
`MASITC_01077442
`
`MASIMO2005
`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`44
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operators Manual
`
`PAGE 34 OF 76
`
`MASITC_01077443
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE PATIENT CABLE CONNECTORS
`ARE NOT WATERPROOF). DO NOT STERILIZE BY IRRADIATION, STEAM, AUTOCLAVE
`OR ETHYLENE OXIDE.
`
`MH DONOT ATTEMPT TO REPROCESS, RECONDITION OR RECYCLE MASIMO
`SENSORS OR PATIENT CABLES AS THESE PROCESSES MAY DAMAGE THE
`ELECTRICAL COMPONENTS, POTENTIALLY LEADING TO PATIENT HARM.
`
`Numeric Display - SpO9
`Stability of the SpO, readings may be a goodindicatorof signalvalidity. Although stability is a relative
`term, experience will provide a good feeling for changesthat are artifactual or physiological and the
`speed,timing, and behaviorof each. Thestability of the readings overtimeis affected by the averaging
`mode being used. The longer the averaging time, the more stable the readings tend to become. This
`is due to a dampened response as the signal is averaged over a longer period of time than during
`shorter averaging times. However, longer averaging times delay the response of the oximeter and
`
`reduce the measuredvariations of SpO, and PR. Inaccurate measurements may be caused by
`
`
`Elevated levels of carboxyhemoglobin
`
`
`Elevatedlevels of methemoglobin
`Intravascular dyes such as indocyanine green or methylene blue
`Externally applied coloring (such as nail polish)
`
`
`
`
`
`
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
`
`45
`
`PAGE 35 OF 76
`
`MASITC_01077444
`
`MASIMO2005
`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Elevated levels of bilirubin
`
`Lowarterial perfusion
`Motion artifact
`
`Low arterial oxygen saturation levels, including altitude induced hypoxemia
`Hemoglobin synthesis disorder
`Hemoglobinopathy
`Thalassemias
`
`Peripheral vascular disease
`EMIradiation interference
`
`Numeric Display - SpOC (upgraded Instrument)
`Astable SpOC reading is associated with stable readings for both SpO» and SpHb which comeswith
`correct sensor placement, small physiological changes during the measurement and acceptable levels
`of arterial perfusion at the measurementsite. Physiological changes at the measurementsite are
`mainly caused byfluctuations in the oxygen saturation, blood concentration and perfusion.
`
`naccurate measurements may be causedby:
`
`Intravascular dyes such as indocyanine green or methylene blue
`Externally applied coloring (such as nail polish)
`
`
`
`
`
`46
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operators Manual
`
`PAGE 36 OF 76
`
`MASITC_01077445
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen
`saturation, blood concentration and perfusion.
`
`Inaccurate measurements may be caused by:
`
`Elevated levelsof bilirubin
`
`
`Motion artifact
`
`Low arterial oxygen saturation levels including altitude induced hypoxemia
`
`
`
`
`
`Numeric Display- Pl
`The Perfusion Index (Pl) display provides a relative numeric indication of the pulse strength at the
`monitoring site. It is a calculated percentage between the pulsatile signal and nonpulsatile signal of
`arterial blood moving through the site. PI may be used to find the best perfused site and to monitor
`physiological changesin the patient. It displays a range of < .1%to > 5%on the bar graph display anda
`numerical range of 0.03% to 20.0%on the display screen. A percentage greater than 1.00%is desired.
`Extreme changesin the display number are due to changes in physiology and blood flow.
`
`Pleth Variability Index - PVI (upgraded Instrument)
`The Pleth Variability Index (PVI) is a measure of the dynamic changes in the perfusion index (PI)
`that occur during the respiratory cycle. The calculation is accomplished by measuring changesin Pl
`over a time interval where one or more complete respiratory cycles have occurred. PVI is displayed
`as a percentage (0-100%).
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
`
`47
`
`PAGE 37 OF 76
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`MASITC_01077446
`
`MASIMO2005
`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`OXYGENATION STATUS THROUGH OTHER MEANS.
`Actions to be Taken
`
`
`
`
`
`
`
`If the SpO,readings show significant differences, do the following:
`
`
`Make sure the emitter and photodetector are aligned directly opposite eachother.
`
`
`Select a site where the distance between the emitter and photodetectoris minimized.
`
`Wipe the sensorsite with a 70% isopropyl alcohol pad or rubefacient cream (10-30% methyl
`salicylate and 2-10% menthol) and allow to dry for 20-30 seconds. Strong vasodilator creams,
`such asnitroglycerin paste, are not recommended.
`If possible, removeelectrical noise sources such as electrosurgical units or other electrical/
`electronic equipment.
`If artificial nails or excessive fingernail polish are present, select anothersite or remove the
`polish/artificial nails.
`If possible, ensure that the sensoris placed in a location with low ambientlight.
`CAUTION:
`IF ANY MEASUREMENT SEEMS QUESTIONABLE, FIRST CHECK THE PATIENT'S VITAL
`SIGNS BY ALTERNATE MEANS AND THEN CHECK THE PULSE CO-OXIMETER FOR PROPER
`FUNCTIONING.
`
`
`
`
`
`
`4-8
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
`
`PAGE 38 OF 76
`
`MASITC_01077447
`
`MASIMO2005
`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
`
`49
`
`PAGE 39 OF 76
`
`MASITC_01077448
`
`MASIMO2005
`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`INSTRUMENT BELOW 5°F (-15°C) DUE TO ALKALINE BATTERY TECHNOLOGY.
`
`4-10
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operators Manual
`
`PAGE 40 OF 76
`
`MASITC_01077449
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`MASIMO2005
`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
` ©%s/610@
`
`Power"on/off" button. Press this button to turn the Instrument on.
`Press-and-hold for 2 seconds to turn the Instrumentoff.
`
`Setup Menu
`
`This section gives an overview of the Rad-57 menu selections available. To navigate through the
`menus,use the Enter, Next, Up and Downkeyslocated on thefront panel of the Pulse CO-Oximeter,
`below the LED display. The following sub sections describe each menuitem in more detail. The Pulse
`CO-Oximeter has options that allow user configuration to suit specific needs.
`
`Menu Navigation
`The Rad-57 set-up and configuration options are accessed through the menu system. The Enter key
`is used to enter the menu system and to move through the different menulevels. Within each level of
`the system, the Next key is used to move from one option to the next. The Up and Down arrow keys
`are used to select values within each option. The parameter/measurementis set/selected wheneither
`the Enter or Next keys are pressed.
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
`
`att
`
`PAGE 41 OF 76
`
`MASITC_01077450
`
`MASIMO2005
`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`PR Low Alarm Limit
`
`
`to adjust parameterto desired
`setting.
`
`
`PR High Alarm Limit
`
`SpHb* Low Alarm Limit
`
`‘available
`Instrument
`
`in
`
`upgraded
`
`
`PI Low Alarm Limit 0|00/000000/0/00O PI High Alarm Limit
`
`SpHb* High Alarm Limit
`
`PVI* Low Alarm Limit
`
`PVI* High Alarm Limit
`
`412
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
`
`PAGE 42 OF 76
`
`MASITC_01077451
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`MASIMO2005
`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`signal. FastSat is automatically enabled in 2 and 4 second averaging.
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operator's Manual
`
`PAGE 43 OF 76
`
`413
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`MASITC_01077452
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`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-01300
`
`
`
`NOTE: The date and time must be set before trending will be enabled. The Rad-57 will automatically
`‘time out’ of the setup menu after 10 secondswith no key presses.
`If the Rad-57 should time-out of the
`Trend Settings menu, the trend will not be enabled.
`NOTE: Enabling trend (setting Trend to “ON”) will eraseall trend information in the Rad-57.
`
`4-14
`
`Rad-57 Signal Extraction Pulse CO-Oximeter Operators Manual
`
`PAGE 44 OF 76
`
`MASITC_01077453
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`MASIMO2005
`Apple v. Masimo
`IPR2022-01300
`
`MASIMO 2005
`Apple v. Masimo
`IPR2022-0130
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