C-me BodyGuard 545 Color Vision User manual

• Thisguideisnotintendedtobecomprehensiveinstructions
 forthesetupandoperationoftheinfusionpump.For 
 completepumpinformation,refertothe BodyGuard545Color
 Vision™ DirectionsForUse.
• Somescreensinthisguidemayvarydependingonthewaythe
 pumpissetup.Theyareforreferencepurposesonlyandmaybe
 differentthantheinformationdisplayedonyoursystem.
• Beforeoperatingthepump,usersshouldconsultthefull 
 directionsforuse.
• Ifyouneedassistancewithsettingupormaintainingthe
 equipmentortoreportunexpectedoperationorevents,contact
 themanufacturerormanufacturer’srepresentative.
BodyGuard 545 Color VisionTM
Quick Reference Guide (Clinical)
On/Off
button
Keypad Lock
button
Info
button
Backup Display
rate/VI/VTBI
Infusion Status
indicator
Bolus Port
connector
AC/Battery
indicator
Stop/No/Back/
Cancel button
Start/OK
button
Prime/Bolus
button
Door Latch
lever
SoftwareVersionBGCV_545_06A

2/20|QRG999-683ENRev.00
Infusion Setup
• Ensurethepumpissecuredinthepumpcharger.
 Ensurethepumpandchargerarefastenedtothe
 pole(ifusingpole)usingtherollerwheelatthe
 backofpumpcharger.
• Switchonthepumpbypressing .Start-up 
 screenappearsforfewseconds.
• Plugtheboluscableintothesideofthepump 
 labeled“Bolus”.Refertothe BodyGuard545Color
 VisionDirectionsforUse formoreinformationon
 howtousetheboluscable.
• Ifapplicable,Protocol(druglibrary)isdisplayedat
 bottomofscreen.Verifyitiscorrect.Contacta
 clinicalsupervisororbiomedengineer,ifneeded.
STEP 1
STEP 2 • Differentoperationsmayrequireacode.Enterthe
 codeandpress .
• Consultyourclinicalsupervisorasnecessary.
• Alockboxmaybeusedtolockthedevice/ 
 medication.Ensurethatthekeyissecuredby 
 authorizedpersonnel.
STEP 3
• Ensuretheappropriateinfusionset 
 hasbeenselected.Onlyusededicated
 BodyGuard sets.
• Checkthatthesterilizedinfusionset 
 packageisnotdamaged.
• Followtheinstructionssuppliedwiththe
 infusionset.
• Ifdoorisdifculttoclose,opendoorfully
 toverifycorrectloadingofinfusionset.
• Leftgure-1:blackkey;2:bluering
 (anti-stretchlocator).
BodyGuard 545
Color Vision Epidural
Pump Serial Number: V123456
Production Date: 1-Jan-2000
Software Version
BGCV545_02B
Protocol Sample
Level One Code
**********
Enter and Press Key
Forsafetyreasons,securitycodesshouldonlybegiventothe
appropriatepersonnel.
12

QRG999-683ENRev.00|3/20
• Insertthebagspikeintotheuidcontainer.
• Ifadripchamberispresent,llthedripchamber
 halfway.
STEP 4
STEP 5 • Pulldownthedoorlatchtoopenthedoor.
• Securelyttheblackkeyintothepressuresensor
 tmentontherightside.
• Locatetheblackkeyintothepressuresensor.
• Thetwoprotrusionsmustfaceup.Thekeycan
 onlybeloadedinthisdirection.
• Ensurethattheowdirectionisinlinewiththeow
 directionarrowsinsidethepump.Thearrowsindicate
 thedirectiontothepatient.
STEP 6 • Locatethebluering(anti-stretchlocator)intheleftside
 ofthetubingchannelaroundtheairsensors.
• Closethedoorfullyuntilaclickisheard.
Loading Infusion Set
Adripchambermaynotbepartoftheset.Usetheavailable
spiketopiercethereservoir.

4/20|QRG999-683ENRev.00
• Thescreendisplaystheprimingprogress.
• Oncompletion,thescreenwillreturntothemain
 menu.
• Youcanstopprimingbypressingthe key.
• Ensurethatthepatientisdisconnectedpriorto
 startingtheprimefunction.
• Followtheinstructionsonthescreentoproceed.
• Toprimeandeliminatetheairfromtheset,select
 theautomaticprimefunctiononthemainmenu.
Infusion Set Priming
STEP 1
STEP 2
STEP 3
Theprimefunctionmustnotbeperformedwhilethesetis
connectedtothepatient.Infusionofaircanleadtoair
embolismwhichmayresultinseriousinjuryordeath.
Primefunctionmustbeperformedbeforeanychangeininfusion.
EPIDURAL 10:00 -70% █ ■
Priming
██████████████
1 5mL
(Press key to Stop)
EPIDURAL
10:00 -70% █
■
Prime
Select Protocol
Change Bag
View Protocol Settings
View Shift Totals
View Patient History
View Event Log
Clinician Bolus
Select , and press
EPIDURAL 10:00 -70% █ ■
Warning !
Disconnect Patient
Press key to Prime

QRG999-683ENRev.00|5/20
• Selecttheappropriatedrug.Incaseofdoubt, 
 contactaclinicalsupervisororbiomedengineer.
• Foranewpatient,enteranumericpatientID 
 numberandpress .Ifyoudonothave 
 apatientID,skipthatstepandpress .
• Foranexistingpatient,press .
• TheIDnumberwillbestoredinthepump’sevent
 log.
• Fromthemainmenu,scrolltoSelectProtocol 
 usingthearrowkeys.
• Press toselectSelectProtocol.
• Entertheleveloneaccesscode.
• Followtheinstructionsonthescreentoproceed.
Start New Infusion
STEP 3
STEP 1
STEP 2
Ifnodrugisavailable,returntothemainmenuandselect
“ModifyProtocols”.Inordertoaddandeditthedruglibrary,
consultaclinicalsupervisor.
EPIDURAL 10:00 -70% █ ■
Prime
Select Protocol
Change Bag
View Protocol Settings
View Shift Totals
View Patient History
View Event Log
Press - Exit Menu
Select , and press
EPIDURAL 10:00 -70% █ ■
New Patient?
Patient ID:
Answer or
EPIDURAL 10:00 -70% █ ■
A:Levobupivacaine .
.
B: Bupivacaine
Select , and press

6/20|QRG999-683ENRev.00
Start New Infusion
• OntheSummaryscreen,reviewtheinfusion 
 parametersandconrm.
• Tomakechanges,pressthe key.
STEP 5
STEP 6
A: Levobupivacaine
Bag Volume 10 mL
Vol. Remaining 10 mL
Rate 2ml/hr
Patient Bolus 3 ml
Lockout Time 15min
Protocol Limit Off
Patient Weight 60 kg
to Confirm or to Change
• Enterpatientweightinkgandconrm.
• Waituntilashingiscompletebeforemovingto
 thenextstep.
• Weightmustbewithintheprotocollimits.
• Re-enterifnecessaryandconrm.
EPIDURAL
10:00 -70% █
■
A: Levobupivacaine
Patient weight
55 kg
Enter and Press Key
STEP 4
• Optional:auto-bolusalertisdisplayedonlywhen
 thisfunctionisenabled.
EPIDURAL 10:00 -70% █ ■
A: Levobupivacaine
Warning ! Patient will
Periodically receive
an automatic bolus.
Press to Confirm

QRG999-683ENRev.00|7/20
Start New Infusion
Infusion Screen
• Press keytobeginyourinfusion.
• Ifthisisnotconrmed,pumpwillalertafter2 
 minutes.
STEP 7
STEP 8 • Optional:ifauto-bolusisenabled,choosewhether
 tostartwithauto-bolusortodelayauto-bolusand
 begintheinfusionprogram.
• Pressthe keytobeginwithaloadingdose
 (clinicianbolus).
• LoadingDoseisoptional.TobypassLoadingDose,
 pressStart.ToinitiateLoadingDose,press .
EPIDURAL 10:00 -70% █ ■
Start Infusion ?
Press key to start
for Loading Dose & Start
Tostoptheinfusionatanytime:
• Pressthe key,recommendedaction.Or,
• Closetherollerclampandthenopenthedoor.
Protocol&ProtocolLetter
BasalRate(ml/hrormg/ml)
Patientbolusvolume
(Whenapplicable)
Autobolusvolume
(Whenapplicable)
Titlebar-typeoftreatment,
time,batterystatusindicator
Timebetweentwopatient
boluses(Whenapplicable)
Timebetweentwoauto
boluses(Whenapplicable)
ActualPressureBar
EPIDURAL 10:00 -70% █ ■
A: Levobupivacaine
air
Rate: 2mL/hr
Patient Bolus Dose 10 mL
Lockout Time 30 Minutes
Auto-Bolus Dose 2 mL
Auto-Bolus interval 15 Minutes
█████████████████████████
110 of 350 mmHg
EPIDURAL 10:00 -70% █ ■
Start Auto-Bolus?
Press key to start
Press to Delay Auto-Bolus
for Loading Dose & Start

8/20|QRG999-683ENRev.00
• Ifabolusisstopped,theremainderwillbe 
 available.
• Selectwhethertoresumethebolusinfusionor 
 returntothemaininfusion.
• Followtheonscreeninstructions.
• Bolusprogressisdisplayedonthescreen.
• Youmaystopthebolusatanytime.
Todeliveraclinicianbolusduringinfusion:
• Pressthe key
• Pressthe key.
• Entertheleveltwocodeandpress .
• Entertheclinicianbolusdosewithintheprotocol
 limits.
Clinician Bolus Delivery
STEP 1
STEP 2
STEP 3
IftheVTBIisreachedduringabolus,anEndofInfusion
alarmwillsound.
EPIDURAL
10:00 -70% █
■
Bolusing
███████████████████
Bolus Dose 5 mL
Bolus Rate 2 mL/hr
████████████████████████
20 of 400 mmHg
EPIDURAL 10:00 -70% █ ■
Clinician Bolus
Dose
5mL
(Maximum 20mL)
Press Key to Start
EPIDURAL
10:00 -70% █
■
Pump Stopped
███████████████████ 2 min
Bolus Interrupted
0.078 mL of 20 mL Delivered
Patient Bolus available in 1 Minutes
to Deliver Remaining Bolus
to Cancel Remaining Bolus
ClinicianBolusmaybedisabledintheprotocol.

QRG999-683ENRev.00|9/20
Rate Titration, Keypad Lock,
Resume/Repeat
Rate Titration Tochangerateduringinfusion:
• Enteranewrateandconrmwith key.
• Enterlevelonecodeandpress .
• Singlealarmsoundsasconrmation.
• Makesurethenewrateisdisplayedonthescreen.
Keypad Lock Keypadlockpreventsunauthorizedchanges:
• Pressandholdthe keytolockorunlockthe
 keypad.
• Duringlockmodeyoumay:
◊Stop/starttheinfusion
◊Muteanalarm/alert
◊Switchoffthepump
EPIDURAL 10:00 -70% █ ■
A: Levobupivacaine
air
Rate: 2mL/hr
Patient Bolus Dose 10 mL
Lockout Time 30 Minutes
Auto-Bolus Dose 2 mL
Auto-Bolus interval 15 Minutes
████████████████████████████████
110 of 350 mmHg
EPIDURAL 10:00 -70% █ ■
Keypad
Lock Mode
████████████████
Off On
Resume/Repeat
Continuous 10:00 -80% ███ ■
Resume – Press
Repeat – Press
• Pumpwasswitchedoffbeforethelastinfusion 
 hasended.
◊SelectResumetocontinuefromthelast 
 stoppedposition.
◊SelectRepeattostartanewinfusion.

10/20|QRG999-683ENRev.00
Atendofaninfusion:
• Theinfusionstops.
• Analarmsounds.
• Ifapplicable,aKVOratewillstartautomatically
 unlessinterrupted.
• Followtheinstructionsonthescreentoproceed.
Change Bag
STEP 1
STEP 2 Ifabagchangeisrequiredatendofaninfusion:
• Selectthefeaturefromthemenu.
• Continuetonextscreen.
Ifabagchangeisrequiredpriortoendofan
infusion:
• Press torecordtheVTBI/VI.
• Stoptheinfusion.
• GotomenuandselectChangeBag–follow 
 instructionsonscreen.
EPIDURAL 10:00 -70% █ ■
End of Infusion
Keep Vein Open
Rate 2.5 mL/hr
Press Key to Menu
EPIDURAL
10:00 -70% █
■
Prime
Select Protocol
Change Bag
View Protocol Settings
View Shift Totals
View Patient History
View Event Log
Clinician Bolus
Select , and press
EPIDURAL 10:00 -70% █ ■
Change Bag
Press when done

QRG999-683ENRev.00|11/20
• Bag/infusionnearlynished.Preparenewbag
 ifapplicable.
• Theinfusionhasended.Thescreenmayshowa
 KVOrateifitwassetup.
• Approximately30minutesofbatteryoperation
 remaining.
• Verifythatapowersupplyisaccessible.
Alarms
Near End
End of Infusion
Low Battery
EPIDURAL 10:00 -70% █ ■
End of Infusion
Keep Vein Open
Rate 2.5 mL/hr
Press Key to Menu
EPIDURAL
10:00 -70% █
■
Near End
EPIDURAL 10:00 -20% ██ ■
Low Battery
Connect to Charger

12/20|QRG999-683ENRev.00
• Thesetisloadedincorrectlyoranon-proprietary
 sethasbeenloaded.Reloadsetaccordingtothe
 infusionsetdirectionsforuse.
• Pump“Stopped”orunattendedfor2minutesor
 more.Resumeinfusionorturnoffthepump.
• Ifthepumpisturnedoff,youwillhavetheoption
 toresumefromthelastposition.
• Batterydepleted.Connecttomainsorreplace 
 thebatteryimmediately.
Alarms
Pump Paused Too
Long
Missing Key
End Battery
EPIDURAL 10:00 -70% █ ■
Pump Paused
Too Long
Press key
EPIDURAL 10:00 -70% █ ■
Missing Set Key
Load Set Key & Close Door
Press key to mute
EPIDURAL 10:00 -2%███ ■
End
Battery
Connect to Charger

QRG999-683ENRev.00|13/20
• Airinthesetorocclusionabovethepump.
 Disconnectpatientandprimetheairoutofset.
 Checkforocclusion.
• Asystemerroroccurred.Followinstructionson
 thescreen.Iferrorpersists,contactservice
 personnel.
• Thepumpdoorhasopenedduringinfusion.Check
 set,closedoor,andresumeinfusion.
Alarms
Air/Up Occlusion
Door Open
Error
EPIDURAL
10:00 -70% █
■
Door Open
Close door
EPIDURAL 10:00 -70% █ ■
Restart Pump
Switch off & on
ERROR XX
EPIDURAL 10:00 -70% █ ■
Air/Up
Occlusion
Check for air / occlusion
Press key to mute

14/20|QRG999-683ENRev.00
• Patientsideocclusionoccurred.Autoresume 
 featuremonitoringback-pressuretodetermineif
 infusioncancontinue.
◊Press tomute
◊Clearocclusioninthesetorinfusionsite—
checkcatheterforocclussionorforclosedclamps
◊Press keytoresumeinfusion
Despitethebenetsprovidedbyearlydetectionofocclusions
andreducedtimetoalarm,thepumpisnotdesignedto
provideprotectionordetectionofextravasationnorinltration,
therefore,theclinicianmustalsochecktheinfusionsiteon
aregularbasisandfollowhospitalprotocolswheninfusion
complicationsoccur.
Whenanalarmactivates:
• Infusionstops.
• Infusionstatusindicatorilluminatesashingred,ashing 
 yellow,orsolidyellow.
• Alarmsoundcontinuouslyuntileitherpumpispausedor 
 problemrectied.
• Alwaysnotetheconditionbeforestoppingthepump.
Down Occlusion
Alarms
EPIDURAL 10:00 -70% █ ■
Down
Occlusion
Check Set / Access
Press key to mute

QRG999-683ENRev.00|15/20
Cleaning & Maintenance
Beforeconnectingthepumptoapatient,andperiodicallyduringuse,clean
theunitasinstructedbelow.
Periodicmaintenanceisrecommendedevery1year.Periodicmaintenanceis
designedtoensurethepump’saccuracyanddetectandrepairanypotential
pumpinconsistenciespriortotheiroccurrenceintheeld.Refertothedirec-
tionsforuseforinformationaboutperiodicmaintenance.
Thereisnoadditionaltimerequiredfortheunittoequilibrateonceremoved
fromminimumtomaximumstoragetemperatures.Ensuretooperatethe
pumpwithinthespeciedoperatingrange.
Theexpectedservicelifeofthepumpandchargeris3years.
TheratingofthepumpisIP33.Thisisthemoistureprotectionratingand
indicatesthedegreeofparticleandwateringressprotection.
• Alwaysturnthepumpoffandremovethebatterybefore 
 cleaning.
• AlwaysunplugthechargerfromACpowerbeforecleaning.
• Donotcleanthepumporchargerwithchemicalssuch 
 asXylene,Acetone,orsimilarsolvents.Thesechemicalscan
 causedamagetoplasticcomponentsandpaint.Usealint-
 freeclothwithhydrogenperoxide10%orisopropylalcohol
 70%.
• Donotsteamautoclave,ethyleneoxidesterilizeorimmerse
 anypartofthepumporchargerinanyuid

16/20|QRG999-683ENRev.00
Intended Use
TheBodyGuard545ColorVision™infusionpumpsystemisdesignedfor
patientswhorequireepiduralpainmanagement,requiringcontinuousand/
orintermittent(bolus)deliveryatprecisely-controlledinfusionratesthrough
clinicallyacceptableroutesofadministrationsuchasepiduralandintrathecal
routes.
TheBodyGuard545ColorVision™infusionsystemisforuseby,orunderthe
supervisionoftrainedmedicalstaffinthehospitalorhomecareenviron-
ments.
• Donotoperatethepumpnearhigh-energyradio-frequency
 emittingequipment,suchaselectro-surgicalcauterizing 
 equipment.Falsealarmsmayoccur.
• DonotoperatepumpinanMRIenvironmentorinthe 
 presenceofstrongmagneticeld.Seriousinjuryordamage
 tothepumpmayoccur.
Ambulance Use
Pumpsmaybeusedinroadambulancesbyparamedicsandambulance
emergencymedicaltechnicians.
Pumpsmustbe30cmawayfromotherdevicesthatmaycreateRadio
FrequencyInterference.
Hazards
Potentialstrangulationmayoccurifcables/tubingareofexcessive
length.
Potentialchokingmayoccurifsmallpartsareinhaledorswallowed.
Potentialallergicreactionsmayoccurduetomaterialsusedinthe
pump.
Children,pets,replaces,dust,lint,directsunlightallmayaffectthe
pumpoperation.

QRG999-683ENRev.00|17/20

18/20|QRG999-683ENRev.00

QRG999-683ENRev.00|19/20

Place Contact Information Here
BodyGuard 545 Color Vision™ is a registered trademark of
Caesarea Medical Electronics Ltd. or one of its subsidiaries.
Caesarea Medical Electronics Ltd.
16 Shacham Street, Industrial Park
Caesarea North, P.O.BOX 3009
Caesarea 3088900, Israel
www.cme-infusion.com
MedNet GmbH
Brokstrasse 10 48163
Muenster, Germany
[phone]