Cheetah Medical Starling SV User manual

Starling™SV

UserGuide

R-IFU-05/Revision3

STARLING SV SYSTEM

User Guide

In the US:

CheetahMedical, Inc. 600 SE Maritime Ave Suite 220

Vancouver, WA 98661

USA

Toll free:([phone] Telephone: [phone] Fax: [phone]

In Europe and Asia

Cheetah Medical (UK) Limited

1, Irmar House

59, Cookham Road

Maidenhead

Berkshire SL6 7EP

United Kingdom

Telephone: [phone]

Fax: [phone]

E-mail: [e-mail] Web Site:www.cheetah-medical.com

Cheetah Medical 2016

Table of Contents

Conventions used in this manual.........................................			4
1.0	Introduction.....................................................................		6
1.1	Introduction.....................................................................		6
1.2	General Description........................................................		7
1.3	Front and Buttons...........................................................		7
1.4	Rear and cables................................................................		8
1.5	Specifications.................................................................		11
1.6	NIBP...............................................................................		12
1.7	Bedside Care..................................................................		22
1.8Label.................................................................................			22
1.9	Battery Mode.................................................................		23
1.10		Warnings and Precautions..........................................	23
Warnings...............................................................................			23
Precautions...........................................................................			24
1.11		Cleaning and Disinfecting the Starling SV Device..25
1.12		Special Patient Populations........................................	25
1.13		Indications for Use......................................................	26
1.14		Limitations of Use.......................................................	27
1.15		SpO2.............................................................................	28
2.0	Screens Overview..........................................................		33
2.1	Start Up Screen..............................................................		33
2.2	Menu Screen..................................................................		34
2.3	New Patient Screen.......................................................		35
2.4	Existing patient..............................................................		36
2.5	Run Screen.....................................................................		37
2.6	Trend Display Screen....................................................		43
2.7	Tabular Display Screen.................................................		44
2.8	Protocol Dashboard Display screen............................		46
2.9	Hemodynamic Dashboard Screen...............................		46
2.10		Settings Screen.............................................................	47
2.11		Set Option....................................................................	50
2.12		General Options..........................................................	51
2.13		Test Options................................................................	52
2.14		NIBP Options.............................................................	53
2.15		SpO2 Options..............................................................	54
2.16		Art Options..................................................................	55
2.17		Connectivity.................................................................	56
2.18		Network Configuration.............................................	57
2.19		Date and Time.............................................................	58
2.20		Device Mode................................................................	59
2.21		Service Mode Screen...................................................	60

2.22		Live Demo and Demo Screens..................................	61
2.23		Shut down Screen........................................................	62
2.24		WI-FI options..............................................................	63
3.0B Basic Functions...........................................................			64
3.1	Saving a New Patient....................................................		64
3.2	Performing a Session....................................................		64
3.3	Viewing Test Results.....................................................		67
3.4	Entering Events.............................................................		69
3.5	Calibrating the Touch Screen.......................................		71
4.0	Settings & Advanced Functions..................................		72
4.1	Height Units...................................................................		73
4.2	Weight Units..................................................................		73
4.3	Electric Grid..................................................................		73
4.4	Audible Alarm................................................................		73
4.5	Date Format...................................................................		73
4.6	Time Format..................................................................		73
4.7	Test Type........................................................................		74
4.8	Sample Interval..............................................................		74
4.9	TFCd...............................................................................		75
4.10		NIBP.............................................................................	75
4.11		NIBP Operation Mode...............................................	76
4.12		NIBP Time Interval....................................................	76
4.13		NIBP Initial Inflation Pressure..................................	76
4.14		Date and Time Setup..................................................	78
4.15		Connectivity Wizard....................................................	78
4.16		Networking Wizard.....................................................	79
4.17		Hgb Posting Period.....................................................	80
4.18		SpO2 Operation Mode...............................................	80
4.19		Art Operation Mode...................................................	81
6.0	Measurements Short Description................................		82
6.1 CO...................................................................................			82
6.2	CI.....................................................................................		82
6.3	HR...................................................................................		82
6.4 VET................................................................................			82
6.5 dX/dt..............................................................................			82
6.6	SV....................................................................................		82
6.7	SVI..................................................................................		83
6.8	SVV.................................................................................		83
6.9	TFC.................................................................................		83
6.10		TFCd.............................................................................	83

6.11		TFCd0...........................................................................	83
6.12		BP..................................................................................	83
6.13 MAP..............................................................................			83
6.14		TPR...............................................................................	84
6.15		TPRI.............................................................................	84
6.16		CP..................................................................................	84
6.17		CPI................................................................................	84
6.18		Z0..................................................................................	84
6.19		DO2I............................................................................	84
6.20		SpO2.............................................................................	84
6.21		Hgb...............................................................................	84
6.22		SBP.............................................................................	84
6.23		DBP.............................................................................	85
7.0	Troubleshooting............................................................		86
7.1		Error Messages............................................................	86
7.2		Warning Messages.......................................................	90
7.3		Other Problems...........................................................	90
8..0SERVICE AND MAINTENANCE.........................			93
8.1	Cleaning..........................................................................		93
8.2	Fuse Replacement.........................................................		94
8.3	Chargeable Batteries......................................................		94

8.4Electromagnetic Compatibility – Manufacturer Declaration

...............................................................................................	95
9.2 Equipment and Accessories Inventory.....................	102
Returning Parts under Warranty......................................	102
Shipping Parts....................................................................	103

Conventions used in this manual

WARNINGIndicatesconditionsorpracticesthatcouldleadtopatientinjury, illness,ordeath

CAUTIONIndicatesconditionsorpracticesthatcoulddamagetheequipmentor otherproperty.

NoteProvidesadditionalimportantinformation.

Consultoperatinginstructions

Manufacturer

Temperaturerange

Relativehumidityrange

AtmosphericPressurerange

Useby

Donotreuse

LatexFree

Europeanapprovalmark

AuthorizedrepresentativeintheEuropeanCommunity

SerialNumber

TypeBFAppliedPart

Storeinacoolandkeptawayfromdirectsunlightplace

Storeinadryplace

Donotopen

Donotdisposeof,contactforrecycling

FCCSymbol

Non-ionizing electromagnetic symbol

5

PatientInformationBar-AppearsonallRunscreens.Thisbarholdsallofthe patient'sinfoasitwasinsertedintothesystem,suchas:ID,Name,Gender,Age, Weight,HeightandBSA.ThePatientInformationBaralsoholdstheTestTypeIcon ('R'forresttestingor'S'forstresstesting).

RunBar-AppearsonallRunscreens.ThisbarholdstheStudyRefreshClock, Alarmstatusicon,Teststatusicons(play,pauseorstop)andtheMessageDisplay area.

MenuBar–AppearsonalloftheSTARLINGSV'sscreens.Thisbarholdsthe

ScreenName,OperationHelpline,Date,TimeandBatterystatus.

NoteInordertoreachthesubmenu–firstenterthescreen'spop-upmenuby clickingtheSTARLINGSV'sBackbutton.Then,eitherclicktheSTARLINGSV's OKbuttonoruseitsRightarrowkeytoenterthesubmenu.*Alliconsdescribedaccording

toorderofappearance-fromlefttoright

5

Chapter

1

1.0Introduction

1.1Introduction

The Starling™ SV System is a portable, non-invasive cardiac output (CO) monitoring device based on BIOREACTANCE® technology. It also measuresHeart Rate (HR), Stroke Volume (SV), Stroke Volume Variation (SVV), Ventricular Ejection Time (VET), Mean Arterial Pressure (MAP), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Blood Oxygenation (SpO2) and Thoracic Fluid Content (TFC). In addition the system calculates clinical parameters such as Cardiac Index (CI), Stroke Volume Index (SVI), Total Peripheral Resistance (TPR), Total Peripheral Resistance Index (TPRI), Cardiac Power (CP), Cardiac Power Index (CPI), Oxygen Delivery Index (DO2I), Thoracic Fluid Content delta (TFCd) and Thoracic Fluid Content delta from baseline(TFCd0) based on the above measured parameters or based on a manually entered parameters such as manually entered Hemoglobin (Hgb), manually entered blood oxygenation (SpO2) or manually entered Mean Arterial Pressure (MAP). The NIBP functionality measures and displays systolic, diastolic, and mean arterial pressures. The SpO2 functionality measures and displays SpO2.

The Starling SV® Operator’s Manual contains instructions and information for the operation and maintenance of the Starling SV System.

A thorough understanding of the system controls and connections is vital for instrument operation. It is therefore essential to read this manual carefully before attempting to use the Starling SV System, in order to ensure optimal performance and trouble free service life. This manual should be retained for future reference.

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1.2 General Description

TheStarlingSVSystemdimensionsare:

Height: 220mm

Width:290mm

Depth:190mm

TotalWeight:4.3Kg

1.3 Front and Buttons

On the front there is an 10.4" LCD screen, knoband three buttons. . In order to turn the unit on, press continuously on the power button until it turnsGreen or Orange and the Cheetah Logo is prompted on the screen; in order to turn the unit off, use the Shut Down command on the mainmenu (section 2.22).

Alternatively, pressing the power button continuously for several seconds will also turn the unit off, however this shut down method is discouraged because some test information may not be saved. Use the STARLING SV'sknob in order to choose commandsfrom the menu, to change measurements' display during a test. In addition, the knob can be used to browse and look up values within fields, to move the cursor between fields, to browse test segments when reviewing patient test results. The STARLING SV'sBack button servesto operate the pop-up menu and to return the cursor to previous placement. The menu button opensand closes the menu display when pressed.

Figure1.1 StarlingSVSystemFrontPanel

7

TouchScreen:

Inadditiontothethreebuttonsandknob,theSTARLINGSVSystemisequipped withatouchscreen.

NavigationinMenus

Touchamenuoptiontoimmediatelyselectit.ToopentheSideMenuwiththe

TouchScreen,touchtheMenuNameonthesideofthescreen.

BrowsingThroughTrendsandTableDisplay

Tobrowsethroughthetrendsandtablespresentedbythemonitor,touchthearrows ofthededicatedslider.ForfasterbrowsingdragtheSliderbody.Itisalsopossibleto sweepthefingeroverthetrendstothedirectionrequired.

BrowsingThroughEvents

IntheNumericalandTrendsdisplaysskipbetweeneventsbytouchingtheEvents

BrowsingToolonthescreen

Changingthetrendsscale

Inordertochangethescaleofthetrendsmovetwofingersapartortowardseach

other. ItisalsopossibletochangethetrendsscalebychoosingTimeScale fromtheSideMenuViewOptionandthenthetimescalerequired.

1.4 Rear and cables

Observetherearsideandtherightsideofthemonitorbox:

8

Figure1.2 BackpaneloftheStarlingSV

Figure 1.3 Front and side of theStarling SV

9

Inthesideofthedevicetherearefivecablesockets:

1.StarlingSVPatientCableconnector–theconnectorisintendedfortheStarling SVPatientCable.Theotherendofthepatientcableshouldbeconnectedtothe StarlingSVSensorswhichareappliedtothepatient’sbodyasdescribedinthe section'PerformingaTest'(sectionnumber3.2).

NoteTheStarlingSVPatientCableisconnectedtotheStarlingSVusingan ODUtypeconnector.Inordertoconnectitpushtheconnectorandturnit clockwiseuntilit’slockedinordertopreventdisconnectionthatwouldleadtoloss ofmonitoringfunction.

WARNINGItisadvisedtocleantheStarlingSVPatientCablebetween patientsinordertopreventthetransferofinfectiousdiseases(seeinSection8.2. ServiceandMaintenance,Cleaning)

2.NIBPcuffconnector–ConnecttheNIBPcufftothemonitorusingtheNIBP connector(pleaserefertofigure1.2).

3.SpO2connector–ConnecttheSpO2SensortothemonitorusingtheSpO2 connector(pleaserefertofigure1.2).

Intherearofthemonitorthefollowingconnectorarepreset:

1.IBPconnector–Forfuturefunctionality.

2.Powersocket–standardelectricpowersocket. Thedevicecanalsofunctiononits internalchargeablebatteries.Connectingthiscabletoanelectricsourcewillsupply themonitorfromthemaingridandchargethebatteries.

3.USBport–connectingastandardUSBcableallowstheusertodownloadresults ofprevioustestsstoredintheStarlingSVtotheStarlingSV EMRPCapplication. InordertoperformtheseactionsitisnecessarytoinstalltheStarlingSVEMRPC softwaretoaPC.ThesoftwareCDcomeswitheverynewmonitorandcanalso beaccessedbycontactingaCheetahMedicalServicerepresentative. TheUSB portalsoenablesvarioustechnicaloperationssuchasuploadingofsoftware upgrades.

4.Serialport–ToconnectthemonitortoanexternalEMRserialconnection.

5.Ethernet–ToconnectthemonitortoanexternalEMREthernetconnection.

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1.5 Specifications

SkinVoltageTolerance:	±300mV
FrequencyResponse:	8Hz
TimeConstant:	0.125Sec
CMRR:	70db
Filter:	75KHz
SafetyRequirements:	AccordingtoIEC/EN60601-1standard.ClassI
	EquipmentBFtypeappliedpart.
RatedVoltage/Current:	Powerswitchsupply100Vto240V
Ratedfrequency	50/60Hz.
Fuses:	2XT2AL250V
A/D	converterat12bit(2.5mVLSB).
Samplerate	500persec.
Features	Hemodynamicdisplayoptions
	Height/Weightunits
	DedicatedStarlingSVElectronicMedicalRecords
	interface(XlSPDF&XMLfileformats,Password
	Protection)
	Hemodynamicstatusreportwithvisit-to-visitdata
	ClinicalProtocolWizards
	EventManagement
	TouchScreencontrol
	SerialandEthernetconnections
AmbientTemperatureandHumidity:
Operationcondition:	10-40°C/50-104°F,50-75%RH
Atmosphericpressure:	700hPato1060hPa
Storagecondition:	0-50°C/32-122°F,50-75%RH
Deliverycondition:	0-50°C/32-122°F,50-75%RH

TechnicalCharacteristicsofAcquisitionModule

IsolatedpreamplifierinaccordancewithIEC60601-1standard.

NoteTheStarlingSVisnotdefibrillatorproof.

11

1.6 NIBP

Terminology:

Oscillometry

Theoscillometricmethodofbloodpressuremeasurementisanon-invasivemethod thatmonitorstheamplitudeofcuffpressurechangesduringcuffdeflationto determinearterialbloodpressure.Thecuffpressureisfirstelevatedabovethepatient systolicbloodpressurelevelandthecuffbeginstodeflateatacertainrate.Theinitial riseinamplitudeofthesepressurefluctuationsduringcuffdeflationcorresponds closelytothesystolicbloodpressure.Asthecuffisfurtherdeflated,thesepressure fluctuationsincreaseinamplitudeuntilapeakisreachedwhichisusuallyreferredtoas themeanarterialpressure(MAP).Ascuffdeflationcontinues,thediastolicpressure canbedeterminedbasedupontherapidlydiminishingamplitudeofthepressure fluctuations.Thussystolic,MAPanddiastolicbloodpressurescanbeaccurately obtainedbysupervisingthepressurefluctuationswhilecontrollingthecuffdeflation rate.

mmHg

MillimetersofMercury,whichisthemostcommonunitofmeasureforpressurein non-invasivebloodpressure.

bpm

Beatsperminute,whichisthemostcommonunitofmeasureforpulserate.

Introduction:

TheNIBPmoduleoftheSTARLINGSVdeviceisanoscillometricbloodpressure system. Themoduleisdesignedtotakebloodpressuremeasurementsondemand. Aftereachbloodpressuremeasurement,theModulewilldiscardthepreviousblood pressureresults.AllModuleoperatingparameterswillresettodefaultvaluesatpowerup.AllModulebloodpressurevaluesarediscardedwhentheModuleisreset

PopulationsthatmayusetheNIBPfunction:

Forpediatricandadultpatients,bloodpressuremeasurementsmadewiththe AdvantageOEMBPModuleSeriesareequivalenttothoseobtainedbytrained observersusingthecuff/stethoscopeauscultatorymethodwithinthelimitsprescribed byANSI/AAMISP10(meanerrordifferenceof±5mmHgorless,standard deviationof8mmHgorless).

Bloodpressuremeasurementsdeterminedwiththisdeviceareequivalenttothose obtainedbyatrainedobserverusingthecuff/stethoscopeauscultationmethod, withinthelimitsprescribedbytheAmericanNationalStandard,Electronicor automatedsphygmomanometers.TheNIBPModuleperformancewithcommon arrhythmias,suchasatrialorventricularprematurebeatsoratrialfibrillation,hasbeen verifiedbyuseofapatientsimulator.

12

Forneonatalpatients,bloodpressuremeasurementsmadewiththeAdvantageOEM BPModuleSeriesareequivalenttothoseobtainedbyintra-arterialbloodpressure deviceswithinthelimitsprescribedbyANSI/AAMISP10:1992&2002(meanerror differenceof±5mmHgorless,standarddeviationof8mmHgorless).

Theautomaticselectionbetweenthe3NIBPpopulationmodesisperformedwhen theenteringthepatientdemographicinformationasfollows:

Adult–Ageabove12years(Automatic,default)

Pediatric–Weightabove7Kgandage12andbelow(Automatic) Neonate–Weight2.5Kgandbelow(Automatic)

NOTETheusershallbegiventheoptiontoselectNeonateorPediatricNIBP populationmodeifthepatientweightisbetween2.6Kgand7Kgs.

NOTEinNeonatemodethefollowingrangesapply:

Systolic	40-130mmHg
MAP	26-110mmHg
Diastolic	20-100mmHg
InitialInflationPressure	90mmHg(default)
	Variablefrom60to140mmHg

Warnings&Precautions

Thisdeviceshouldnotbeusedwhenoscillometricpulsesmaybealteredbyother devicesortechniquessuchasExternalCounterpulsation(ECP)orIntraAortic BalloonPumpCounterpulsation.

DONOTusetheNIBPmoduleforanypurposeotherthanspecifiedinthis manualwithoutwrittenconsentandapprovalfromCheetahMedical.

DONOTusethedeviceinthepresenceofflammablegaseousanesthesiaagents becauseofflamehazard.

DONOTattachthecufftoalimbbeingusedforIVinfusionsoranyother intravascularaccess,therapyoranarterio-venous(A-V)shunt.Thecuffinflationcan temporarilyblockbloodflow,potentiallycausingharmtothepatient.

DONOTapplytheBPcuffoverawoundasthiscancausefurtherinjury.

DONOTForpatientsthathavehadamastectomy,cuffshouldbeappliedto oppositearm.

CAUTIONSubstitutionofacomponentdifferentfromthatsuppliedmayresultin measurementerror.Repairsshouldbeundertakenonlybypersonneltrainedor authorizedbyCheetahMedical.Donotmodifythisequipmentwithoutauthorization fromCheetah-Medical.

13

CAUTIONAccuracyofanybloodpressuremeasurementmaybeaffectedbythe positionofthesubject,hisorherphysicalconditionanduseoutsideoftheoperating instructionsdetailedinthismanual.Interpretationofbloodpressuremeasurements shouldbemadeonlybyaphysicianortrainedmedicalstaff.

CAUTIONAllairhosesandcuffsusedtoconnectthepatienttothemodulemust beapprovedbyCheetahMedical.Hosesofacertainmaterialand/ordurometermay causethemoduletoperforminanimproperfashion.Also,cuffsthatareextremely smallorlargeinvolumemaycauseerrorstooccurdependingontheBPmode selection.AirhosesaswellascuffsareofferedasaccessoriesfromCheetahMedical.

CAUTIONIfthebloodpressurecuffisonthesamelimbasmonitoring equipment(i.e.,pulseoximeterprobe),thepressurizationwithinthecuffcancause temporarylossoffunctionofthemonitoringequipment.

CAUTIONIfthebloodpressurecuffisonthesamelimbasapulseoximeter probe,theoxygensaturationresultswillbealteredwhenthecuffoccludesthebrachial artery.

CAUTIONToobtainaccuratebloodpressurereadings,thecuffmustbethe correctsize,andalsobecorrectlyfittedtothepatient.Incorrectsizeorincorrect fittingmayresultinincorrectreadings.

CAUTIONWhenacuffisusedonapatientforanextendedlengthoftime,be suretooccasionallycheckthelimbforpropercirculation.

CAUTIONIntra-armdifferencesvarybetweenpeople.Donotassumethat measurementsfrombotharmsaresame.

CAUTIONThemodulemaynotoperatecorrectlyifusedorstoredoutsidethe relevanttemperatureorhumidityrangesdescribedinthePerformancespecifications.

CAUTIONIntendedpatientpopulationincludeadult,pediatricandneonate patients.Safetyandeffectivenessonpregnantwomenandneonateshavenotbeen tested.

CAUTIONForneonatepopulations,theclinicaleffectivenessofthisdevicehas notbeenestablishedinthepresenceofdysrhythmias.Arterialreferencesitesincluded femoral,umbilicalandradialarteries.

NOTEForadultandpediatricpopulations,K5wasusedtoclinicallyvalidate diastolicpressure.

CAUTIONCheckthatoperationoftheunitdoesnotresultinprolonged impairmentofthecirculationofthepatient.

14

CAUTIONNeonatesmeasurementsmustalwaysusea3meterspatienthose inordertoavoideoverpressureerrorscausedbyalackofairvolumewithinthe overallpneumaticsystem.

CAUTIONAcompressedorkinkedconnectionhosemaycausecontinuouscuff pressureresultinginbloodflowinterferenceandpotentiallyharmfulinjurytothe patient.

CAUTIONToofrequentBPmeasurementscancauseinjurytothepatientdueto bloodflowinterference.

CAUTIONPressurizationoftheBPcuffcantemporarilycauselossoffunctionof simultaneouslyusedmonitoringequipmentonthesamelimb

WARNINGRegardingtheeffectofbloodflowinterferenceandresultingharmful injurytothePATIENTcausedbycontinuousCUFFpressureduetoconnection tubingkinking.

WARNINGRegardingtheneedtocheck(forexample,byobservationofthelimb concerned)thatoperationoftheAUTOMATEDSPHYGMOMANOMETERdoes notresultinprolongedimpairmentofthecirculationofthebloodofthepatient.

AdverseReactions

Allergicexanthema(symptomaticeruption)intheareaofthecuffmayresult, includingtheformationofurticaria(allergicreactionincludingraisededematous patchesofskinormucousmembranesandintenseitching)causedbythefabric materialofthecuff.

Petechia(aminutereddishorpurplishspotcontainingbloodthatappearsontheskin surface)formationorRumple-Leedephenomenon(multiplepetechia)ontheforearm followingtheapplicationofthecuff,whichmayleadtoIdiopathicthrombocytopenia (spontaneouspersistentdecreaseinthenumberofplateletsassociatedwith hemorrhagicconditions)orphlebitis(inflammationofavein)maybeobserved.

CuffSelection&Placement

Itisimportanttoselectthecuffsizethatisappropriatetothediameterofthepatient's upperarm.UsetheRangeLinesontheinsideofthecufftodeterminethecorrectsize cufftouse.

WrapthecuffaroundthearmmakingsurethattheArteryMarkerisalignedoverthe brachialartery(asshowninFigure1.3).Ifpossible,donotwrapthecuffoverthe patient'sclothing.Thecuffshouldfitsnugtothepatient'sarmformaximum oscillometricsignalquality.Anappropriatesizedcuffshouldbeplacedonthenon-

15

dominatearmwheretheloweredgeofthecuffislocated2cmabovetheantecubital fossa(interiorbendoftheelbow).

Figure 1.3NIBPCuffPlacement

Ensurethattheairhosefromthemonitortothecuffisnotcompressed,crimpedor damaged.

The midpoint of the subject's upper arm should be supported at heart level for proper measurement accuracy. When the cuff is below heart level, measurement results may be higher and when the cuff is above heart level, measurement results maybelowerthancomparativeresultsobtainedatheartlevel.

Pleaserememberthatusingacuffthatisthewrongsizemaygivefalseand misleadingresults.

NoteTheNIBPmoduleisdesignedtoworkwithSunTechcuffsandhoses. TheuseofcuffsandhosesnotsuppliedbyCheetah-MedicalorSunTechmay compromiseperformanceandaccuracy.

Note The initial inflation pressure will be selected via the "Initial Inflation" option that is located on the NIBP Settings' screen unless automatically specified bytheNIBPpatientpopulationmode(Neonate,Pediatric).

CuffsizesavailableforusewiththeStarlingSV:

			Range	Bladder
Part #	Description/Size		(cm)	(cm)
98-0080-04	All-Purp, Small Adult		17-25	9.8x20.3
98-0080-05	All-Purp, Small Adult Long		17-25	9.8x20.4
98-0080-06	All-Purp, Adult		23-33	13x27.5
98-0080-07	All-Purp, Adult Long		23-33	13x27.6
98-0080-08	All-Purp, Large Adult		31-40	16.3x33
98-0080-09	All-Purp, Large Adult Long		31-40	16.3x33
98-0080-10	All-Purp, Thigh		38-50	20x40

16

NIBPModulePerformance

Method of Measurement

Oscillometric. Diastolic values correspond to Phase 5

Korotkoff sounds.

Blood Pressure Range:	Systolic:	ADULT	40-260 mmHg
		PEDIATRIC	40-230 mmHg
		NEONATE	40-130 mmHg
	MAP:	ADULT	26-220 mmHg
		PEDIATRIC	26-183 mmHg
		NEONATE	26-110 mmHg
	Diastolic:	ADULT	20-200 mmHg
		PEDIATRIC	20-160 mmHg
		NEONATE	20-100 mmHg
Pulse Rate Range:	30 to 220 BPM (Beats Per Minute)
Pulse Rate Accuracy:	± 2% or ± 3 BPM, whichever is greater
Cuff Deflate Rate:	Deflation step size varies with heart rate, cuff pressure
	and cuff volume.
Initial Inflation Pressure:	ADULT:	160 mmHg (Default)
		Variable from 120 to 280 mmHg
	PEDIATRIC:	140 mmHg (Default)
		Variable from 80 to 280 mmHg
	NEONATE:	90 mmHg (Default)
		Variable from 60 to 140 mmHg
Clinical Accuracy:	Meets accuracy requirements of ANSI/AAMI SP10,
	EN1060-4 and ISO 81060-2.
Pressure Transducer Accuracy:	±3mmHg between 0 mmHg and 300 mmHg for
	operating conditions between 0°C and 50°C
Recommended Frequency of	The pressure transducer calibration should be verified on
Pressure Transducer Calibration:	a yearly interval
Operating Conditions:	0°C to 50°C, 15% to 95% non-condensing humidity
Storage Conditions:	-20°C to 65°C, 15% to 90% non-condensing humidity
Altitude:	Measurement accuracy is not affected by altitude
Startup Initialization Period:	7 seconds
Minimum time between	50 milliseconds
commands:

Patient Safety:

Internal operating software ensures that:

Maximum initial inflation time is limited to 75 seconds

Duration of blood pressure reading is limited to 130 seconds (Adult/Peds mode)

120 seconds (Adult/Peds Motion Tolerant mode)

75 seconds (Neonate mode)

Additional redundant safety circuitry oversees normal operation and will override to abort a reading if:

cuff pressure exceeds 300 mmHg (Adult & Pediatric modes) or 150mmHg (Neonate mode) at any time

the cuff has been inflated for 180 seconds (Adult & Pediatric modes) or 90 seconds (Neonate mode)

17

The module meets all relevant parts of the following Safety

Standards:

IEC60601-1:1997 2nd Edition

IEC60601-1:2005 3rd Edition

IEC/EN60601-2-30:1999/2000

IEC 80601-2-30:2009

AAMI SP10:2002(R)2008

ISO 81060-2:2009

EN1060-1:1996+A2:2009

EN1060-3:1997+A2:

ErrorCodeList&Definitions

CAUTIONWenanNIBPerroroccurs,measurementvalueswillstillbereported.

Thesemeasurementvaluesshouldbedisregardedwhenanerrorcodeisreported.

Artifact/ErraticOscillometricSignal

CorrectiveAction:

•Thepatientmayhavebeenmovingtoomuch.

•Checkthatthecuffisinthecorrectpositions.

•Checkthatthecorrectsizecuffisbeingapplied.

Exceededretrycount

CorrectiveAction:

•Thepatientmayhavebeenmovingtoomuch.

•Checkthatthecuffisproperlytightened.

•Checkthatthecuffisinthecorrectposition.

•Checkthatthecorrectsizecuffisbeingapplied.

•Checkthatthereisnoexcessiveclothingbetweenthearmandthecuff.

Exceededmeasurementtimelimit

CorrectiveAction:

•Thepatientmayhavebeenmovingtoomuch.

•Checkthatthecuffisproperlytightened.

•Checkthatthecuffisinthecorrectposition.

•Checkthatthecorrectsizecuffisbeingapplied.

•Checkthatthereisnoexcessiveclothingbetweenthearmandthecuff.

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PneumaticBlockage

CorrectiveAction:

•Checkthatthehosehasnosharpbendsorispinched.

•Checkthatthepatientisnotlyingonthecuff.

•Checkthatthecuffisinthecorrectposition.

InflateTimeout,AirLeakorLooseCuff

CorrectiveAction:

•Checkthatthehoseisconnectedtothesystemandthecuff.

•Checkthatthecuffisproperlytightened.

•Checkthatthecuffisinthecorrectposition.

•Checkthatthecorrectsizecuffisbeingapplied.

•Checkthatthecuffisnotleakingair.

•Checkthatthehoseconnectionsarenotdamagedorloose.

SafetyTimeout

CorrectiveAction:

•Checkthepatient.

•Checkthatthecuffisinthecorrectposition.

•Thepatientmayhavebeenmovingtoomuch.

•TakeanotherBPreading.

CuffOverpressure

CorrectiveAction:

•Checkthatthecorrectsizecuffisbeingapplied.

•Checkthatthehosehasnosharpbendsorispinched.

•Checkthatthecuffisinthecorrectposition.

•Checkthatthepatientisnotlyingonthecuff.

Powersupplyoutofrangeorotherhardwareproblem

CorrectiveAction:

Servicemayberequired.CallaCheetahMedicalrepresentative.

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Permissionproblem

CorrectiveAction:

Servicemayberequired.CallaCheetahMedicalrepresentative.

Transduceroutofrange

CorrectiveAction:

Ifpossible,performcalibration.

Servicemayberequired.CallaCheetahMedicalrepresentative.

ADCoutofrange

CorrectiveAction:Servicemayberequired.

CallaCheetahMedicalrepresentative.

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EEPROMcalibrationdatafailure

CorrectiveAction:

Ifpossible,performcalibration.

Servicemayberequired.CallaCheetahMedical representative

ErrorMeasuringNIBP–CriticalNIBPmoduleerror.

CorrectiveAction:

Servicemayberequired.CallaCheetahMedical representative

DeviceBusy–NIBPdeviceisnotrespondingasitisinthe middleofanactivity.

CorrectiveAction:

•RetrytoobtainanNIBPreading.

•Ifthiserrorpersists,restarttheunitandtryagaintoobtainan NIBPreading.

Ifyoustillencountertheerrormessageafterrestartingtheunit, servicemayberequired.CallaCheetahMedicalrepresentative

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1.7 Bedside Care

ToensurethattheStarlingSVsignalswillberecordedtoanadequate standard,itisimportanttofollowthebelowguidelines:

StarlingSVSensorPlacement

1)Shavebodyhairandwipethepatient’sskinwithalcohol(70%)ifnecessary. Ifalcoholisusedtopreptheskin,itisadvisedtolettheskindrypriorto placementoftheSTARLINGSVsensorsinordertopreserveoptimalgel performance.Finally,usetheskin-prep“sandpaper”providedinthesensor settoroughentheskin.

PlacetheSTARLINGSVSensorsonthepatient’sskinasseenbellow(Figure1.4)

Figure1.4StarlingSVPrewiredSensorPlacement

NoteWhenthesensorsaremisplacedorbecomedetachedthescreenwilldisplaya warningthatwillnotifytheuserthatthereislossofsignalorpoorsignalquality.

CAUTIONDonotuseStarlingSVsensorsaftertheexpirationdate.

CAUTIONIntheunlikelyeventthatthepatienthasanallergicreactiontothe STARLINGSVsensors,detachthesensorsimmediatelyfromthepatientandavoid anyfurtherplacementofStarlingSVsensorsonthispatient.

1.8 Label

ThefollowinglabelisattachedtotheCheetahSTARLINGSVdevice:

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1.9 Battery Mode

TheStarlingSVmonitorcanfunctionwithoutexternalpowerconnection.Inthis modeofoperation,whenfullycharged,thebatteriescanprovideupto6hoursof power.Tofullychargethebatterywhenitisdepleted,itisnecessarytoconnectthe devicetotheexternalpowersupplyforapproximately4hours.

Whenthemonitorisdisconnectedfromtheexternalpowersupplythebatteries automaticallypowertheunitsothattheusershouldnotexperienceanyinterruption

inthetest.Thebatterychargeindicator reflectsthatthesystemcurrently operatesinbatterymodeandisdependentonbatterycapacity.Whenconnectedto theexternalpowersourcethebatterychargeindicatorwillindicatethatthebatteryis

beingchargedandtheamountofbatterychargeremaininginagraphicway.

Ifthebatterylevelfallsto10%orlower, awarningmessagewillappear.

Toprotectthemonitorandthemonitordata,thesystemwillshutdownautomatically withoutuserpromptifthechargelevelfallsunder5%.

CAUTIONIn order to prevent loss of data or study interruption, working in battery mode is only recommended for short periods of time, for example during transport and not for routine testing.

1.10 Warnings and Precautions

Warnings

WARNINGUSFederalLawrestrictsthesaleofthisinstrumentto,oronthe orderofaphysician.

WARNINGWhentheUSBconnectionisnotused,thesocketshouldbecovered withtheUSBcapatalltimes.

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Precautions

CAUTIONStrictlyfollowthewarninginstructionsinthismanual.

CAUTIONTheinstrumentisfragile;topreventdamagepleasehandlewithcare andavoiddroppingit.Becarefulwhileunpacking.Forsystemrepackinginstructions pleaserefertopage75onthisguide.

CAUTIONEnsurethatthesystemisonlyusedbyatrainedpersonfamiliarwithall systemoperatingprocedures. Hospitalpersonnelshouldcompleteatrainingprogram priortooperatingtheStarlingSV.

CAUTIONToavoiddamagetotheinstrumentorsensors,becarefulofliquid spillagewhilecleaning.

CAUTIONDonotexposetheinstrumentorsensorstosprays,liquidsoranyother typeofsolvent.

CAUTIONToavoiddamagetothesurfaceoftheinstrumentorsensors:

Avoidexcessivepressurewhencleaningthelettering.

Donotusesolventsordetergentsforcleaning.

Donotcleanthesensorswithanabrasive.

NoteScratchesonthesurfaceofthesensorswillcauseinaccuratedatarecording.

CAUTIONToavoiddamagetotheLCDscreen-donotexposetheinstrumentto directsunlightforlongperiodsoftime.

CAUTION Userisprohibitedfromchanging,adding,removingordisassembling anysystemparts. Warrantyshallnotapplytoanydefects,failureordamagecausedby improperuseand/orimproperorinadequatemaintenanceandcare.

CAUTION TheunitisclassifiedasClassIIb,continuouslyoperated,ordinary equipmentwithappliedpartandwithsignalinputoutputparts.Thedeviceisnot intendedforuseinthepresenceofflammablemixtures.

NoteThecontentsofthismanualaresubjecttochangewithoutpriornoticefor improvementofanalysisprecision.

NoteUsedsensorsshouldnotbeplacedwithcommonhouseholdwasteproducts. Contactlocalauthoritiesforthelocationofachemicalwastecollectionprogram nearestyou.

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1.11Cleaning and Disinfecting the Starling SV Device

CAUTION The Starling SV system is classified as non-waterproof. To avoid damage to the STARLING SV monitor and its accessories (including the STARLING SV patient cable, the NIBP hose and cuff), avoid entrance of liquids during use and cleaning.

CAUTION Be sure to turn the power off and disconnect the AC power cord from the power source before performing cleaning procedures.

CAUTION To avoid damage to the surface of the instrument:

Avoid excessive pressure when cleaning the printed labeling on the monitor frame in the front and rear panel, as well as the adhesive labels on the rear panel

Take care not to scratch the front display while cleaning

CAUTIONStarling SVsensorsare single-use disposable products and should never be reused, cleaned or exposed to liquids. If necessary, replace the sensorsif they become wet or soiled. Reuse of the sensors can cause infection, allergic reaction and loss of hemodynamic parameters.

To clean or disinfect the monitor perform the following:

This instrument requires routine cleaning, which includes removal of any soil or dirt from the external surfaces. A soft cloth dampened lightly with water may be used.

To disinfect external monitor surfaces, and reusable accessories such as the Starling SV patient cable, clean with 70% medical grade alcohol using a dampened soft towel or wipe.

Do not expose the instrument, patient cable orsensorsto sprays, or any other type of solvents.

ForStarling SV accessories labeled as manufactured by third-party suppliers, follow the respective manufacturer’s instructions for recommended care and maintenance.

1.12 Special Patient Populations

Therearepopulationsofspecificinterestinwhichthismonitorhasnotbeen tested,including.

Patientswithcongenitalheartdiseaseassociatedwithcomplexintra-cardiacshunts.

PatientswithContinuousFlowLVADs: TheStarlingSVtechnologyworksby detectingpulsatilechangesinaorticbloodvolume. WithacontinuousflowLVAD, bydefinition,therearelittleifanypulsationsunlesstheheartitselfejects.Therefore,

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useoftheStarlingSVdeviceinthesepatientscouldbeusefulindetectingthe contributionofthenativehearttothecardiacoutput,butwouldnotdetectthe contributionoftheLVAD. Theresults,therefore,shouldbeinterpretedwiththis inmind.

1.13 Indications for Use

The Starling SV with NIBP and SpO2 functionalities is a portable, hemodynamic monitoring non-invasive Cardiac Output monitoring device that monitors and displays a patient’sCardiac Output (CO) in Ltr/Min with a Non Invasive Blood Pressure (NIBP) function that non-invasively measures and displays blood pressure (diastolic, systolic and mean arterial pressure) and heart rate and with a SpO2 function that non-invasively measures and displays blood oxygen saturation (SpO2). In addition, by slaving off the Philip’s patient monitor the STARLING SV can display continuous blood pressure measurements taken from the arterial line. For slaving the Philip patient monitor contact a Cheetah Medical Service representative The device displays associated hemodynamic parameters based on measurements or calculations of measurements already incorporated into the Starling SV. These parameters are:

Cardiac Index (CI),

Stroke Volume (SV),

Stroke Volume Index (SVI),

Stroke Volume Variation (SVV),

Heart Rate (HR),

Ventricular Ejection Time (VET),

Total Peripheral Resistance (TPR),

Total Peripheral Resistance Index (TPRI),

Cardiac Power (CP),

Cardiac Power Index (CPI),

Blood Oxygenation (SPO2)

Oxygen Delivery Index (DO2I),

Electrical impedance of the chest cavity (Z0),

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Thoracic Fluid Content (TFC),

Thoracic Fluid Content change from preset time period (TFCd) and

Thoracic Fluid Content from baseline (TFCd0).

Changes in SV, CO and other hemodynamic parameters which are derived by Bioreactance®as a result of posture

The Starling SV with NIBP and SpO2 functionalities is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care.

1.14 Limitations of Use

ClinicalSituationsPotentiallyAffectingSTARLINGSVAlgorithm

AccuracyorPerformance

NoteMostoftheclinicalsituationsandpatientconditionslistedbelowmayimpact absolutevalues,butshouldnotaffectdeviceresponsivenessandsensitivity/specificity toassessdirectionalhemodynamicchanges.Theexceptionisincircumstancesof severeexternalpacemakerinterference.

ExamplesofconditionsthatcaninfluencereportedCO,influencemonitor accuracy,orresultinsuboptimalsignalquality.

1.Severeaorticinsufficiency

Theregurgitationfractionassociatedwithseverecasesofaorticinsufficiencymay resultinoverestimationofthenetforwardCO.ThatisbecauseStarlingSV measurestheejectionbutdoesnotsubtractthebackwardregurgitationthattakes placeduringdiastole.

2.Severeanatomicabnormalitiesofthethoracicaorta

Severeanatomicabnormalitiesofthethoracicaorta,suchasalargesyntheticaortic graft,largeaorticaneurysmorlargeaorticdissectioncanimpacttheaccuracyor performanceofhemodynamicparameters.Theabnormalityhastobelargein ordertohaveameaningfulimpactonmonitoraccuracy.

3.Externalpacemakersandinternalpacemakerswithunipolarelectrodes

Usecautioninmonitoringpatientswithexternalpacemakers,andpatientswith relativelyoldermodelsofinternalpacemakerswhichutilizeunipolarelectrodes. Someexternalpacemakersandunipolarinternalpacemakerscanaddelectrical artifacttotheStarlingSVBIOREACTANCEsignal.

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NoteItispossibletocompletelymitigateorsignificantlyalleviatetheproblemby placingtheStarlingSVsensor2.5inches(approximately6cm)ormoreawayfrom theexternalpacemakerpercutaneouslead. Unipolarinternalpacemakersarerarely usednowadays.

1.15 SpO2 Introduction:

Pulseoximetryisanon-invasivemethodallowingthemonitoringoftheoxygen contentofapatient'shemoglobin.

Asensorisplacedonathinpartofthepatient'sbody,usuallyafingertipor earlobe,orinthecaseofaninfant,acrossafoot.Lightwithredwavelengthsand lightwithinfraredwavelengthsissequentiallypassedfromonesidetoaphoto detectorontheotherside.Changingabsorbanceofeachofthetwowavelengths ismeasured,allowingdeterminationoftheabsorbancesduetothepulsing arterialbloodalone,excludingvenousblood,skin,bone,muscle,fat,and(in mostcases)fingernailpolish.Basedupontheratioofchangingabsorbanceofthe redandinfraredlightcausedbythedifferenceincolorbetweenoxygen-bound (brightred)andoxygen-unbound(darkredorblue,inseverecases)blood hemoglobin,ameasureofoxygenation(SpO2-thepercentofhemoglobin moleculesboundwithoxygenmolecules)canbemade.

PopulationsthatmayusetheSpO2function:

TheStarlingSVSpO2moduleisintendedforusewithneonatal,pediatric,and adultpatientsduringbothnomotionandmotionconditionsandforpatients whoareeitherwellorpoorlyperfused,dependentontheSpO2sensorused.

SpO2SensorsfortheNELL-1SpO2Module:

TheNELLCORDS100SPO2sensorcomessuppliedwiththeSTARLINGSV withtheSpO2functionality. Inaddition,theStarlingSVwithNIBPandSpO2 functionalityisalsocompatiblewithanyofthefollowingNELLCORSpO2 sensorsthathavethefollowingaccuracyspecifications(*Arms):

	Sensor	Adults/Pediatrics	Neonates
		Accuracy	Accuracy
REUSABLE:	D-YS (Infant to Adult)	± 3 digits	± 4 digits
	D-YS with D-YSE Ear	± 3.5 digits	N/A
	Clip
	D-YS with D-YSPD	± 3.5 digits	N/A
	SpotClip
	DS-100A	± 3 digits	N/A
	OXI-A/N	± 3 digits	± 4 digits
DISPOSABLE:	OXI-P/I	± 3 digits	N/A
	OxiCliq A:	± 2.5 digits	N/A
	OxiCliq P:	± 2.5 digits	N/A
	OxiCliq N (adult):	± 2.5 digits	±3.5digits

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OxiCliq I:

± 2.5 digits

N/A

*Arms:Allaccuraciesareexpressedas±“X”digits.Pulseoximeterequipment measurementsarestatisticallydistributed;abouttwothirdsofpulseoximeter measurementscanbeexpectedtofallinthisaccuracy(ARMS)range.

"Neonatal Accuracy: When sensors are used on neonatal subjects as recommended, the specified accuracy range is increased by + 1 digit, as compared to adult usage, to account for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood. For example, OxiCliqN accuracy on neonates is + 3.5 digits, rather than + 2.5."

CleaningandmaintenanceinstructionfortheSpO2sensoraredescribedinthe specificSpO2sensorusermanualwhichissuppliedwiththesensor.

TheSpO2sensorisconnectedtothemonitorviathededicatedSpO2cablethat connectstothededicatedconnectiononthebackofthemonitor(SeeFigure

1.2).

Placethesensoronathinpartofthepatient’sbody(e.g.,fingertiporearlobe,or inthecaseofaninfant,acrossafoot). TostartSpO2monitoringwhilerunning atest,selectStartSpO2fromthemainmenuifSpO2automaticmodeisnotthe defaultmode. WhenthisisdoneSpO2monitoringshallcommence automatically.

NELL-1SpO2ModuleSpecifications:

ThefollowingaretheSpO2modulespecifications:

Patient Range Neonate through adult

Operating Temperature 0 °C to +60°C

Relative Humidity 15% to 95% non-condensing

Altitude 1,000 feet below sea level to 10,000 feet above sea level

Operating Mechanical Shock Per IEC 600068-2-27, 100G, 6 ms half sine

Operating Sinusoidal Vibration Per IEC 600068-2-6, 10 Hz to 500 Hz, 1 G peak, 10 sweeps/axis

Operating Random Vibration Per IEC 600068-2-34, 20 Hz to 500 Hz, 0.02 g2/Hz

Storage Temperature -40 °C to +70°C

Relative Humidity 15% to 95% non-condensing

Storage Altitude 1,000 feet below sea level to 20,000 feet above sea level

Vibration Per NSTA Project 1A

Drop Per NSTA Project 1A

Saturation 1% to 100% SpO2

SpO2SensorsfortheXPODSpO2Device:

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