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.

7
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

8
ECG-Based PICC Tip Confirmation System
Up/Down/Le/
Right Buons
Allows the user to wirelessly highlight icons on the iPad.
Enter Buon AllowstheusertowirelesslymakeseleconsontheiPad.
Front Cover Removingthefourscrewsfromthefrontcoverallowstheusertochangebaery.
5.4. Remote
TheRemoteprovidesawirelessconneconbetweenuserandiPad.Theremoteisnon-sterileandrequirestheuseof
theprovidedbagtocreatethesterileeld.
EnterBuon
ArrowBuons
(Up/Down,Le/Right

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5.6. ECG Snap Lead Set
Thered,whiteandblackECGsnapleadsplugintotheDINports
onthehub.ThesnapststandarddisposableECGpads.TheECG
Snap Lead Set is non-sterile and requires the use of the provided
drapetocreatethesterileeld.
Warning Donotimmersetheexternalpowersupplyinwaterorotheruids,asthismaycreateadangerous
shockhazardtothepaentanduser.
Warning Use only the medical grade external power supply provided with the device. Use of unapproved
powersupplymaycompromisepaentsafetyordamagetheunit.
Warning Never use a visibly damaged external Power Supply. Return to Medcomp for Service.
Warning If the Hub requires the use of the external power supply during a procedure, do not place the Hub
onthepaent’schest.PosiontheHubonaatsurfacenexttopaent.
Warning To avoid risk of electric shock, this equipment must only be connected to a supply mains with pro-
tecveearth.
5.5. ECG Clip Cable
TheECGClipCableispartofthesteriledisposablekit.Ittransmits
thepaentsECGwavesbyconnecngthePICCstylettotheHub.
Conneconsaremadeusingthealligatorclipandstereojack.
Snap Leads
toECGPads
Stereo Jack
to Hub
DIN Leads
to Hub
Alligator
Clip to Stylet
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ECG-Based PICC Tip Confirmation System
10
Warning To disconnect power to the Hub when using the external power supply, remove the external power
supply from the supply mains.
Warning UseonlytheIECapprovedbaeriesprovidedwithC3Wave.Useofunapprovedbaeriesmaycom-
promisepaent/usersafetyordamageunit.
Warning Useofcablesoraccessories,otherthanthosepackagedwithC3Wave,maynegavelyaectEMC
performance.
6. TECHNICAL SPECIFICATIONS
6.1 iPad
SeeiPadowner’smanualfortechnicalspecicaons.
6.2 Hub
Dimensions 4.15” wide x 4.0” high x 1.6”deep
Weight 0.35lb[0.16kg]
InternalBaeryCapacityat77°F[25°C] 800mAh
InternalBaeryVoltageat77°F[25°C] 1.2V
External Power Supply Input: 100-240VAC, 50-60Hz, 0.3A
Output:5VDC,10W
NormalOperangCondions +32°to+95°F[0°to+35°C]
5to95%non-condensingrelavehumidity
StorageCondions -4°to+113°F[-20°to+45°C]
5to95%non-condensingrelavehumidity
HubRang RatedtypeCFpaentprotecon
ExternalPowerSupplyRang Class II, medical grade external power supply

11
6.3 Remote
Dimensions 5.5” long x 2.0” wide x 0.8” thick
Weight 0.18lb[0.08kg]
InternalBaeryCapacityat77°F[25°C] 230mAh
InternalBaeryVoltageat77°F[25°C] 3V
NormalOperangCondions +32°to+95°F[0°to+35°C]
5to95%non-condensingrelavehumidity
StorageCondions -4°to+113°F[-20°to+45°C]
5to95%non-condensingrelavehumidity
RxFrequency 2402-2480MHz
Owner’s Manual
Cauon DonotoperatecellphonesorportableradiotransmierswhenC3Waveisinuse.Thesedevicesmay
interferewithnormaloperaonofthesystem.
Cauon NeveruseC3Wavenearhighintensitymagnecelds,e.g.anMRIscanner.Strongmagnecelds
may damage the system.
Cauon C3 Wave may be interfered with by other equipment even if that equipment complies with CISPR
emission requirements.
Cauon Ifsignicantinterference[noise]isobservedintheECGwaveform,thenoperatetheHubonbaery
power[disconnectACadapter]toisolatetheHubfromthedisrupveenvironment.
Cauon FederalLawintheUnitedStatesrestrictsthissystemtosalebyorontheorderofaphysician.
RxFrequency 2402-2480MHz

ECG-Based PICC Tip Confirmation System
12
7. APPLICATION AND IPAD OPERATION
7.1. Power On iPad
TurnoniPadusingSleep/Wakebuon.
7.2 LAUNCH APPLICATION
Usingthetouchscreen,taptheC3waveapplicaon
to open.
Sleep/Wake
Buon
7.3 NEW PROCEDURE
Using the touch screen, tap “New Procedure” to begin.
C3 App Icon

13
7.5 POWER ON HUB
PressandholdthePowerBuonfortwoseconds.ThebuonwillilluminatebluewhenpowerisON.
7.5.1 Wirelessly Connect Hub to iPad
Thewirelessconneconisautomac.WhentheHubisturnedONthePowerBuonwilliniallyashblue.Whenthe
PowerBuonilluminatessolidbluetheconnecontotheiPadhasbeenmade.
7.5.2 Internal Test
Theinternaltestwindowwillpopupaerthewirelessconneconhasbeenmade.Ifthetestwassuccessful,tapOK
on the touch screen. If service is required, tap Service and return unit to Medcomp.
7.4 ENTER PATIENT ID/NOTE
UsetouchkeypadtoenterPaentID.IfNotesarerequiredenterthemnow.Whennished,tapBeginProcedure.
Owner’s Manual

ECG-Based PICC Tip Confirmation System
14
PowerBuon
Internal Test
Image Place Holder
7.6 Connect 3 Paent Snap Leads
ConnecttheECGSnapLeadstothecorrespondingcoloroftheHub.SnapthedisposableECGAdhesiveElectrodes
fromthekittotheECGsnapleads.

15
7.7 Apply the ECG Adhesive Electrodes to Paents Chest
Cleanthepaent’sskin.RemovetheECGAdhesiveElectrodesclearbackingandapplytopaent’sskin.Note:Avoid
areas with excessive hair.
Followcolorcodes/leeringonHub:RA(White)=RightArm,LA(Black)=LeArm,LL(Red)=LeLeg.
Note: For internaonal use the ECG Snap Lead connecons are: R (Red) = Right Arm, L (Yellow) = Le Arm, F (Green) =
Le Leg.
Note: It is recommended that the Medcomp supplied ECG pads be used.
Owner’s Manual

ECG-Based PICC Tip Confirmation System
16
7.8 Verify Surface ECG Signal
Verifypaent’sECGwaveformisacceptableforuseinguidingPICClocaon.
Note: Paent and PICC must be sll while reading wave forms
Note: If lead is incorrectly posioned or not connected the Lead OFF alert will appear.
7.9 Collect a Baseline ECG Snapshot During Surface Mode
Use Remote to highlight Camera icon. Press Enter to select image. If using touch screen tap Camera icon to select
image.
Leads O Alert
Image Place Holder

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7.10 Enter Surface Measurement
When a snapshot is accepted the Surface Measurement screen will pop-up. Use Remote or touch screen to scroll to
correctmeasurement.Thecurrentseleconwillbehighlightedinthebluebox.PressentertoAcceptmeasurement
or tap Accept if using the touch screen.
Owner’s Manual
7.9.1
If image is correct use Remote to highlight Accept icon. Press Enter to
save image. If using touch screen tap Accept icon to save image.
7.9.2
If image is incorrect use Remote to highlight Refresh icon. Press Enter
to generate new image. If using touch screen, tap Refresh icon to
generate new image.
7.9.3
To quit without saving image, use Remote to highlight Cancel icon and
press Enter. If using touch screen tap Cancel icon.