MedComp C3 WAVE User manual

Owner’s Manual
© 2011-2014 – Medical Components Inc. All Rights Reserved.
Manufactured by: Medical Components, Inc., 1499 Delp Drive, Harleysville, PA 19438 USA Phone: [phone]
1. Symbol Table
2. ImportantNoces
3. Introducon
4. IndicaonForUse/IntendedUse
4.1 IndicaonForUse
4.2 Intended Use
5. FeaturesAndControls
5.1 iPad
5.2 Hub
5.3 Hub Power Sources
5.3.1 Power Supply
5.3.2 Charging Base
5.4 Remote
5.5 Ecg Clip Cable
5.6 Ecg Snap Lead Set
6. TechnicalSpecicaons
6.1 Ipad
6.2 Hub
6.3 Remote
7. ApplicaonAndIpadOperaon
7.1 PowerOnIpad
7.2 LaunchApplicaon
7.3 New Procedure
7.4 EnterPaentId/Notes
7.5 PowerOnHub
7.5.1 Wirelessly Connect Hub To Ipad
7.5.2 Internal Test
7.6 Connect3PaentSnapLeads
7.7 Apply The Ecg Adhesive Electrodes
ToPaentsChest
7.8 Verify Surface Ecg Signal
7.9 Collect Baseline Ecg Snapshot
During Surface Mode
7.9.1
7.9.2
7.9.3
7.10 Enter Surface Measurement
7.11 Enter Internal Mode
7.12 PrepSterileField
7.12.1 Remote
7.12.2 Hub
7.13 Connect Ecg Clip Cable To Hub
7.14 Connect Ecg Clip Cable To Picc
7.15 Verify Picc Ecg Signal
7.16 CollectEcgSnapshotOfDeecon
And Maximum P-Wave
7.16.1
7.16.2
7.16.3
7.17 Enter Impant Depth
7.18 FinishProcedure
7.19 Bundle Protocol Parameters

TABLE OF CONTENTS
Note: For use with soware 1.0.
7.20 Save,PrintOrReplayPaentFiles
7.20.1 Save
7.20.2 Print
7.20.3 Replay
7.21 PowerO
7.21.1 iPad
7.21.2 Hub
7.22 Clean Up
7.22.1 Disposables
7.22.2 Reusables
8. AddionalApplicaonControls
8.1 Ecg Wave Zoom
8.2 Scroll Through Snapshots
8.3 DeletePaentFiles
8.4 SengsAndSupport
8.4.1 AccountSengs/Registraon
8.4.2 Hub Serial #
8.4.3 Remote Serial #
8.4.4 Emr Url
8.4.5 Product Improvement Program
8.4.6 Set Passcode
8.4.7 FirmwareUpdate
9. Cleaning
10. Parts And Accessories
10.1 Parts
10.2 Accessories
11. TroubleShoongGuide
11.1 Alarms,AlertsAndInformaonalMessages
12. Standards,DeclaraonsandLicensing
12.1
12.2
12.3
12.4
13. Maintenace And Service Requirements
13.1 RouneMaintenance
13.1.1
13.1.2
13.1.3
13.1.4
13.2 Semi-Annual Maintenance
13.2.1
13.2.2
13.3 Annual Maintenance
13.3.1
13.3.2
13.3.3
13.4 Service Assistance
13.5 Training
13.6 ReturningUnitForRepair
13.7 DisposalOfUnit
14. Limited Warranty

2. IMPORTANT NOTICES
BeforeusingC3Wave,theusermustthoroughlyunderstandthecontentsofthismanual,inaddion
totheiPadmanual,includingallwarnings,cauons,contraindicaons,andintendeduse.
Warning Thisdeviceisonlyintendedforusebyqualiedandtrainedmedicalprofessionals.Beforeusingthis
device,theusermustbequaliedforplacementofPeripherallyInsertedCentralCatheters[PICC]and
trained in the proper use of this device.
Cauon Beforestarnganewprocedure,verifytheC3Waveapplicaondoesnotrequireupdang.Dothis
bylaunchingtheAppStoreandselecngtheUpdatestab.IfaC3Waveupdateisrequired,theuser
mustfullyunderstandtheupdatespriortostarnganewprocedure.TheWhat’sNewsecondetails
therevisionstotheapplicaon.Aerreviewingtheupdates,selectUpdate,andwaitforthenew
applicaontoload.
1. SYMBOL TABLE
On/O
ReadAccompanyingDocumentsforimportantsafety-relatedinformaon
RatedtypeCFpaentprotecon
Date of Manufacture
Device serial Number
SN
1
Owner’s Manual

3. INTRODUCTION
C3Waveisdesignedtoprovideaconnuousdisplayofelectrocardiograph[ECG]waveformtobeusedasaguidein
placementofperipherally-insertedcentralcatheters[PICC]inperipheralveinsleadingtotheheartofthepaent.The
principleforoperaonofthissystemusesthreeECGleadsplacedonthepaent’schestandgeneratesathirdECGlead
byswitchingfromRAtoPICCstylet.TheECGwaveformiswirelesslytransmiedtoatabletwhichallowstheoperator
toviewandrecordchangestotheECGwaveformasthepofthecatheterapproachestheheart.AsthePICCcatheter
approachestheatriumoftheheart,thePwaveintheECGwaveformshowssubstanalchanges.Thissystemisdesigned
toaidthevisualizaonofchangesinPwaveamplitude.
The C3 Wave system must only be operated by a skilled nurse, physician, or trained medical professional who has been
qualiedinplacementofPICC’sandtrainedintheproperuseofthisdevice.
ECG-Based PICC Tip Confirmation System
2
Warning Never use C3 Wave if dropped or visibly damaged. Remove damaged device from service and return
to Medcomp for service.
Warning DonotimmerseC3Waveinwaterorotheruids.Seriousdamagemayoccur,possiblyresulngin
injurytotheuserorpaent.
4. INDICATION FOR USE/INTENDED USE
4.1 Indicaons for Use
C3WAVEisindicatedforuseasasupplementalaidinposioningforPeripherallyInsertedCentralCatheters(PICC)in
adultpaents.Itprovidesreal-mecatheterplocaoninformaonbyusingthepaent’scardiacelectricalacvity.
Conrmaonofpplacementshouldbeveriedaccordingtoclinicaljudgmentandestablishedhospitalprotocol,
(e.g.,ChestX-ray,Flouroscopy).
Note:Liming,butnotcontraindicated,situaonsforthistechniquearepaentswherecardiacrhythmsmaychange
presentaonoftheP-wave:
-Atrialbrillaon
-Atrialuer

3
Warning C3WAVEworkswiththenormalsinusrhythmoftheheart.DonotrelyonECGsignaldeteconfor
catheterpposioningwheninterpretaonoftheexternalorintravascularECGP-waveisdicult.
Forexample,when:
-P-Wave is not present
-P-Waveisnotidenable
-P-Waveisintermient
Warning ThisdeviceisnotintendedforuseasadiagnoscECGdeviceasthesystemisdesignedtoaidthe
visualizaonofchangesinPwaveamplitude.
Warning DoNOTusethisdeviceinthepresenceofammableanesthecs,oxygen-enrichedatmospheres,or
explosive gases.
Warning This device has not been tested for use near electrosurgical devices. It is not recommended for use
inoperangrooms.
Owner’s Manual
-Severe tachycardia
-Pacemaker-driven rhythm
-Chronicobstrucvepulmonarydisease(COPD)
SuchpaentsareeasilyidenedpriortoPICCinseron.Useofanaddionalconrmaonmethodisnecessaryto
conrmcatheterplocaon.
4.2 Intended Use
C3WAVEisintendedtoproviderealmeplocaoninformaonofacentralvenouscatheterbyulizaonofECGto
observeP-wavechangesasthepapproachestherightatriumoftheheartviathesuperiorvenacava.
5. FEATURES and CONTROLS
TheC3WavesystemiscomposedofaniPad,Hub,PowerSupply,ChargingBase,Remote,adisposableECGClipCable
andECGSnapLeadSet.

ECG-Based PICC Tip Confirmation System
4
5.1 iPad
TheiPadreceivesthepaentinformaonwirelesslytransmiedfromtheHub.Theinteracveapplicaondisplays
theinformaonguidingtheuserduringPICCplacement.Theapplicaonalsoallowstheusertosaveinformaonper-
tainingtotheproceduretothepaent’sle.TheiPadcanbeoperatedinanon-sterileenvironmentusingthetouch
screen or during a sterile procedure by placing the remote inside the sterile bag.
Note: It is recommended that the iPad be mounted with the included VESA mount to prevent drops or other damage.
Sleep/Wake
Buon
Rear iPad
VESA Mount
Home
Buon
C3 App Icon
Mul-TouchDisplay Colorgraphicdisplaywithcapacivetouchscreen.
Sleep/WakeBuon Pressing once will put the iPad in Sleep or Wake mode. Pressing and holding for a few
secondswillturntheiPadOnorO.
VESA Mount FourmounngpointsinVESAstandard75mmsquarepaern.

5
5.2. Hub
TheHuballowstheusertosetupastandardthree-leadECGconnecontothepaentpriortothestartofthePICC
locaonprocedure.DuringthePICClocaonproceduretwoleads[RedandBlack]fromthisHubareusedtogether
withtheECGclip[White]leadonthestyletwiretocreatetheguidanceECGwaveform.TheHubisnon-sterileand
requirestheuseoftheprovideddrapetocreatethesterileeld.
PowerBuon PressandholdfortwosecondstoturnHubON.PowerBuonwillashbluewhile
connecngwithiPad.OnceconnectedthePowerBuonwillilluminatesolidblue.Press
andholdforvesecondstoturnHubOFF.PowerBuonwillnotilluminatewhenHub
isOFF.Pressingandholdingfortensecondswillbreakthewirelessconneconwiththe
Hub.
Stereo Jack ConneconpointforECGClipcable.
PowerBuon BaeryAccessDoor
Stereo Jack
Threeconnecon
pointsforECG
Charging Base
connecon
External Power
Supply
Baery
Indicator Light
Owner’s Manual

ECG-Based PICC Tip Confirmation System
6
BaeryIndicatorLED Baerytest:PressandreleasethePowerBuontoilluminateHubbaeryindicator
LED.Redashindicateschargingisrequired.Yellowashindicatesparallydischarged.
Greenashindicatesfullycharged.
Charging:WhenhubischargingtheBaeryIndicatorLEDwillconnuouslyash.Red
ashindicateschargingisrequired.Yellowashindicatesparallydischarged.Green
ashindicatesfullycharged.
DINconnecons ConneconpointsforECGsnapleads.
BaeryDoor Baeryaccessdoor.Removingthescrewallowstheusertochangebaery.
5.3. Hub Power Sources
5.3.1 Power Supply
Themedicalgradepowersupply[5VDC,10W]isusedtochargeoroperatethehubduringuseifthebaeryislowor
discharged.

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5.3.2 Charging Base
WhennotinusetheHubcanbechargedwhileresngintheChargingBase.Plugthemedicalgradepowersupply
[5VDC,10W]intotheChargingBaseandverifytheHubBaeryIndicatorLEDisashing.
Owner’s Manual