Ambit PIB v1.5 User manual

®
MORE THAN PAIN RELIEF...
SUPERIOR PAIN CONTROL
CLINICIAN MANUAL
ambIT®PIB v1.5 Pumps
IP22 IP22

Become familiar with the ambIT
®
pump
Solution container
Tubing
clamp
BOLUS
button
ambIT
®
Pump
ON/OFF
switch
Remote BOLUS switch
(optional)
Tubing
clamp
Pump display
RUN/PAUSE
button
Cassette
To solution container
(Side view of cassette)
Cassette shaft
To patient

i
Table of Contents
SECTION 1 - INTRODUCTION........................................................................................................1
1.1 DenitionsandSymbols.......................................................................................................1
1.1.1 Denitions ....................................................................................................................1
1.1.2 DenitionofSymbols..................................................................................................2
1.2 Warnings.................................................................................................................................6
1.2.1 Sterile, Disposable (Single-Use) Administration Set ..............................................7
1.2.2 Protection From Air Infusion.....................................................................................8
1.2.3 Protection From Unintended Bolus ..........................................................................8
1.2.4 Use of ambIT
®
PIB v1.5 Pumps in MRI Environment..............................................8
1.3 Indications for Use.................................................................................................................8
1.4 Product Description ..............................................................................................................9
1.4.1 Product Overview .......................................................................................................9
1.4.2 ambIT
®
Pump User Interface ...................................................................................17
SECTION 2 - SET UP .........................................................................................................................18
2.1 Required Materials ..............................................................................................................18
2.2 ambIT® Cassette..................................................................................................................19
2.3 Priming the Cassette ...........................................................................................................19
2.4 Attach Cassette to Pump ....................................................................................................22
2.5 Remove Cassette from Pump.............................................................................................22
2.6 Changing Fluid Reservoir ..................................................................................................23
2.7 Battery Installation and Replacement...............................................................................23
2.7.1 Battery Installation ....................................................................................................23
2.7.2 Battery Replacement .................................................................................................24
2.8 Pump Power On and Off....................................................................................................25
SECTION 3 - PROGRAMMING INSTRUCTIONS ....................................................................26
3.1 General Information............................................................................................................26
3.2 Program Options .................................................................................................................27
3.2.1 PCA Mode ..................................................................................................................28
3.2.2 PIb Mode.....................................................................................................................33
3.2.3 P+P Mode....................................................................................................................37
3.3 Program Review...................................................................................................................42
SECTION 4 - OPERATING INSTRUCTIONS .............................................................................43
4.1 Start Infusion........................................................................................................................43
4.1.1 PCA Mode Start Infusion .........................................................................................43
4.1.2 PIb Mode Start Infusion............................................................................................43
4.1.3 P+P Mode Start Infusion ..........................................................................................44
4.2 Pause Infusion......................................................................................................................44
4.3 Resume Infusion ..................................................................................................................44
4.4 Silence Alarm .......................................................................................................................44
4.5 Bolus Activation...................................................................................................................45
4.6 Summary of Operating Controls.......................................................................................46
SECTION 5 - INFUSION HISTORY REPORTS...........................................................................47
5.1 Pump Infusion History.......................................................................................................47
5.1.1 PCA Mode Infusion History ....................................................................................47
5.1.2 PIb Mode Infusion History.......................................................................................48
5.1.3 P+P Mode Infusion History .....................................................................................48
5.2 Clearing Pump Infusion History.......................................................................................49

ii
SECTION 6 - PATIENT LOCKOUT ...............................................................................................50
6.1 Accessing Lockout Mode....................................................................................................50
6.2 To Lock the Pump................................................................................................................50
6.3 To Unlock the Pump ...........................................................................................................51
SECTION 7 - ALARMS AND SIGNALS .......................................................................................52
SECTION 8 - TROUBLESHOOTING.............................................................................................54
SECTION 9 - SPECIFICATIONS.....................................................................................................55
SECTION 10 - DELIVERY RATE ACCURACY............................................................................57
10.1 Data from Volumetric Accuracy Testing .........................................................................58
10.2 Factors That May Affect Volumetric Accuracy...............................................................58
SECTION 11 - GENERAL CARE INSTRUCTIONS....................................................................63
11.1 Warranty Information.........................................................................................................63
11.2 Cleaning and Disinfecting Instructions............................................................................64
SECTION 13 - CUSTOMER ASSISTANCE ..................................................................................67

Section 1 • Introduction
1
SECTION 1 - INTRODUCTION
1.1 DenitionsandSymbols
1.1.1 Denitions
ANALGESIA: Relief from pain.
BASAL FLOW RATE: Thecontinuousowrate.Itoccurswhenthepumpisnotdelivering
abolusinPCAmode.Thebasalowrateisadjustableandhasunitsofmillilitersperhour
(ml/hr).
BOLUS: A volume of medication infused over a relatively short period of time.1The bolus
isinfusedatthebolusowrate.Abolusisdeliveredwhenapatientrequestsitbypushingthe
BOLUS button or the optional remote BOLUS switch. A bolus is sometime referred to as a PCA
bolus. The bolus has units of milliliters (ml).
BOLUS/DOSE FLOW RATE: Theowrateatwhichabolusordoseisdelivered.Itis
ahigherowratethanthebasalowrate.IntheambIT
®
PIB v1.5 pumps,thebolusowrate
varies from 210 ml/hr to 125 ml/hr, depending on the energy left in the battery. Flow rate
accuracyisnotaffectedbythebolusowrate.SeeSection1.4.1foranexplanationofhowthe
bolusowratechanges.Thebolus/doseowrateisnotadjustable.
CAUTION: A caution usually appears in front of a procedure or statement. Failure to
observeacautioncouldresultinseriouspatientoruserinjury.Cautionsarefoundthroughout
this document emphasized with grey shading.
DOSE: A volume of medication infused over a relatively short period of time2and is
programmed to occur at regularly scheduled intervals. Sometimes a dose is referred to as a PIB
or as a PIEB. In this manual, the term “dose” will be used when discussing either PIB or PIEB.
The dose has units of milliliters (ml).
INTERVAL OR DOSE INTERVAL: The time between the start of one dose and the start
ofthenextdose.Thedoseintervalhasunitsofhoursandminutes(hh:mm).
INTERVAL LIMIT (“IL”): Themaximumamountthatcanbedeliveredwithinadoseinterval
andthemaximumbolusvolumeallowedtobeprogrammed.Thissettingisonlyapplicableto
PIB + PCA (“P+P”) mode for PIB-IL v1.5 pumps.
LOCKOUT TIME: Thetimebetweentheendofonebolusordoseandthestartofthenext
bolusordose.Thelockouttimehasunitsofhoursandminutes(hh:mm).
NOTE: Anotehighlightsinformationthatactsasareminderorhelpsexplainaconceptor
procedure.
P+P: An acronym for a combination of programmable intermittent bolus (“PIb”) and patient
controlled analgesia (“PCA”) and allows for dose volumes occurring at set intervals, as well as
optional boluses.
1 Thebolusisdeliveredatahigherowratethanthebasalrate;therefore,foragivenvolume,thebolusisdeliveredfaster.
2 Thedoseisdeliveredatahigherowratethanthebasalrate;therefore,foragivenvolume,thedoseisdeliveredfast.

Section 1 • Introduction
2
PCA: An acronym for patient controlled analgesia. If a pump is in PCA mode and the patient
has been prescribed a bolus volume, then PCA allows for a lay user to periodically give the
patient a bolus of medication. If the infusion is into the epidural space the PCA is referred to as
patient controlled epidural analgesia (PCEA).
PIB (PIb): An acronym for programmable intermittent bolus. If the infusion is into the
epidural space, the PIB or PIb is referred to as programmable intermittent epidural bolus (PIEB
or PIEb).3Withinthismanual,whenreferringtothepumpitself,“PIB”isused;whenreferring
to the dose, display or mode, “PIb” is used.
VOLUME TO BE INFUSED: Thetotalamountofuidinthesolutioncontaineror
reservoir to be infused. The volume to be infused has units of milliliters (ml).
WARNING: A warning message contains special safety emphasis and must be observed at all
times.Warnings arefound atSection 1.2,aswellas throughout this document emphasized withgrey
shading.Failuretoobserveawarningmessageispotentiallylifethreatening.
1.1.2 DenitionofSymbols
Consult instructions for use.
International symbol meaning “Attention, consult accompanying
documents.”
IECsymbolfor“TypeBFAppliedPart.”(IECClassication:Internally
powered.)
The ambIT
®
pumpcomplieswithES60601-1:2012,1stEdition,
includingAmend.1;CSAC22.2NO.60601-1:2014,3rdEdition;IEC
60601-1:2005,includingCorr.2:2007andAmend.1:2012;IEC60601-1-
6:2013,Edition3.1;IEC60601-1-8:2012,Edition2.1;IEC60601-1-11:2015;
60601-2-24:2012,Edition2;IEC62304:2006,1stEdition;IEC62366:2007,
1stEdition,andAmend.1:2014;IEC60601-1-2:2014,4thEdition,2014-
02.
Protectedagainstinsertionofngersandwillnotbedamagedor
become unsafe during a speciedtestinwhichitisexposedto
vertically or nearly vertically dripping water.
3 In some publications, the PIb is referred to as an “automated bolus” or “automated mandatory bolus.” This usage is less
common than PIb or PIEb.
®
IP22

Section 1 • Introduction
3
Indicatesthemedicaldevicemanufacturer,asdenedinEUDirectives
90/385/EEC, 93/42/EEC and 98/79/EC.
Indicates the date after which the medical device is not to be used.
Indicates the manufacturer’s batch code so that the batch or lot can be
identied.
Indicatesthemanufacturer’sserialnumbersothataspecicmedical
devicecanbeidentied.
Single-use only (cassettes)
Keep away from heat
Keep dry
Caution:Thisdeviceisrestrictedtosalebyorontheorderofa
physician.
Temperature limitation
Sterilized using irradiation
DEHP-freeuidpath
Notmadewithnaturalrubberlatex

Section 1 • Introduction
4
Indicates which tubing connects to
the solution container
Indicates which tubing connects to
the patient
Bolus
Program lockout
Boluslockouttimeinhours:minutes
Bolus volume in milliliters
Volume in milliliters
Basal infusion rate in ml/hr
Number of boluses delivered
Number of bolus requests
Volume to be infused
RUN/PAUSE button
BOLUS button
To patient
To solution container
Cassette
shaft
(side view of cassette)

Section 1 • Introduction
5
Low/dead battery indicator
Alarm indicator
ambIT
®
pump display
Pump power on
Pump power off
Battery orientation
PIb mode
PCA mode
P+P mode
Program lockout code
Program lockout mode
Pump program mode
Review pump program

Section 1 • Introduction
6
1.2 Warnings
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Read instructions before use. The pump must be used strictly in accordance with these
instructions.
Safe use of this pump is the primary responsibility of the user. The user is responsible for
monitoring this pump. Contact clinical/technical support if pump appears to be operating
incorrectly.
All patients should be given a Patient Manual and instructed to read it carefully. The pump
must be used only by or on behalf of the person for whom it is prescribed.
Patients should never perform any function or push any button unless instructed by their
healthcare provider.
Do not allow the pump to get wet. If the pump is immersed in any liquid, it must be replaced
with a new pump.
Transportandstorageconditions:-25ºC(-13ºF)withoutrelativehumiditycontrol;and+70ºC
(+158ºF)atrelativehumidityofupto93%,non-condensing.
The pump will warm from the minimum storage/transportation temperature to room
temperature(about20ºC[68ºF])inapproximately30minutes.Thepumpwillcooltoroom
temperaturefromthemaximumstorage/transportationtemperatureinabout35minutes.
Operatingconditions:+5ºCto+40ºC(+41ºFto+104ºF);relativehumidityrangeof15%to93%,
non-condensing;andanatmosphericpressureof700hPato1060hPa(10.2psito15.4psi).
Never attempt to open the pump case. Only the battery cover may be removed when changing
batteries. If the pump is dropped, it must be replaced with a new pump.
This pump is not to be used for infusion of blood or blood products.
This pump is not to be used for infusion of life-sustaining medications.
Failure to follow manufacturer’s instructions while replacing batteries may result in loss of
program settings and report data. Dispose of batteries properly after use.
Contact the local authorities to determine the proper method of disposal of potentially
biohazardous parts and accessories.
Infusion history report
Pump infusion history cleared

Section 1 • Introduction
7
Thispumpdoesnothaveanairin-linealarm.Acassettewithanaireliminationlteris
available and recommended for intravenous use or where infusion of air would cause a safety
hazard.
Safety hazards with the ambIT
®
pump, including under-infusion, may be associated with
externalradiofrequency(RF)interferenceorelectromagneticradiation.Typicalequipment
thatmaygeneratesuchradiationincludesx-raymachines,magneticresonanceimaging(MRI)
equipment, and any other non-shielded electrical equipment.
Use of any remote BOLUS switch other than the approved remote BOLUS switch could result
in an inadvertent bolus.
Do not use any other administration set other than the approved ambIT
®
cassettes. The pump
will not function properly with any other administration sets.
Do not use additional untested/unapproved components as their use may lead to under-
infusion and the potential of increased pain to the patient.
Nomodicationofthisequipmentisallowed.
The cassette tubing or BOLUS switch cord may cause strangulation if used improperly.
The pump should not be disassembled by any user. If equipment is tampered with to the point
it is ineffective, consult the prescribing physician.
Keep out of reach of animals or children.
Safetyhazardsareassociatedwiththeinterconnectionofotherinfusionsystems.Referto:
Terry, Judy (Ed.), Intravenous Therapy, W. B. Sanders Co. 1995, pp 192–193.
A single cassette should not be used for infusion volumes greater than two liters.
In order to minimize the possibility of infection, cassettes should be changed in accordance
with your institution’s policies.
When the desired volume to be infused has been delivered, the empty solution container must
bechanged.Failuretodosowillresultincessationofuiddelivery.
Before starting therapy, check that all connections are secure and that there are no leaks in the
uidpath.
Bolusandinfusionhistoryreportsshouldnevertaketheplaceofgoodclinicaljudgment.
Always perform a clinical evaluation whenever interpreting these reports.
Infusing viscous solutions (e.g., D25W) into high pressures (e.g., approaching 300mm Hg) may
decrease volumetric accuracy.
1.2.1 Sterile,Disposable(Single-Use)AdministrationSet
• Carefullyexamineeachcassettebeforeuse.Makesuretherearenodamagedor
missing parts.
• Do not use a cassette if the outer package is torn, punctured, wet or damaged.

Section 1 • Introduction
8
• Do not touch the sterile open end of tubing. Use the aseptic technique utilized by
your facility.
• Do not re-sterilize cassette.
1.2.2 ProtectionFromAirInfusion
• The solution must be provided in a non-vented, collapsible container.
• Remove all air from solution container and tubing before use.
• For IV applications, the ambIT® PIB v1.5 pumps should be used with air elimination
ltersbecauseairprotectionisnotprovided.
1.2.3 ProtectionFromUnintendedBolus
• The unintended bolus volume that could be released into a patient prior to clearing
a downstream occlusion may be released by breaking the seal on the connection
between the pump and the catheter.
• Breaking the connection between the catheter and the pump may introduce
contaminationintotheuidpath.Donottrytocleartheunintendedbolusvolume
ifanyconcernsexistaboutintroducingcontamination.
• Themaximumunintendedbolusvolumereleasedintothepatientwhenoccluded
on the downstream side is between 0.050 and 0.10 ml. One stroke of an infusion is
0.050 ml. Since these amounts are similar, there is no risk of over-infusing and the
unintended bolus may not need to be removed.
1.2.4 UseofambIT
®
PIB·v1.5PumpsinMRIEnvironment
Safety in MRI not evaluated. The ambIT
®
PIB·v1.5 pumps have not been evaluated for
safety and compatibility in the MRI environment. The pumps have not been tested for
heating, migration, or image artifact in the MRI environment. The safety of the ambIT
®
PIB v1.5 pumps in the MRI environment is unknown. Scanning a patient who has the
devicemayresultinpatientinjury.
1.3 IndicationsforUse
The ambIT
®
PIB v1.5 pumps are usedtoinfusemedicinesand/oruidsintopatientsprimarily
for pain management.
The routes of administration are generally intravenous, epidural, and/or regional.
The ambIT
®
PIB v1.5 pumps are not intended to supersede, augment, or replace any other
medical device or drug indications for use or intended uses.
The ambIT
®
PIB v1.5 pumps are intended to be used in the home and in healthcare facilities.
NOTE: Any use of the pumps other than those indicated above is regarded as an off-
label use. The ambIT
®
PIB v1.5 pumps are not equipped with an air detection
circuit, therefore if infusion of air could cause harm to the patient, it is
recommendedtousealteredcassetteoraireliminationlter.

Section 1 • Introduction
9
NOTE: SummitMedicalProducts,Inc.doesnotrecommendorendorseanyonespecic
medication to be used with the ambIT
®
PIB v1.5 pumps. The healthcare provider
is the sole individual who decides upon the prescribed medication, pump
programmed parameters, method and location of infusion.
NOTE: Thesuitabilityofthisproductforusewithanyspecicpatientistobe
determined solely by the healthcare provider. The healthcare provider should
understand the interaction between the infusion characteristics of the pump, the
physiological response of a patient to the drug (overall and at the infusion site),
the pharmacokinetics of the drug, any potential adverse effects, etc. This patient-
specicinformationshouldbereliedupontodecideifthepumpshouldbeused
to infuse any medication into any part of the patient’s body. The distributors and
Summit Medical Products, Inc. can only provide general guidelines regarding
thesetupandprogrammingofthepump.Theymayalsoprovidejournal
articlesreferringtoapplications.Theyareneitherqualiednorpermittedto
providespecicrecommendationsfortreatinganyspecicpatient.Ingeneral,
toavoidcomplications,usethelowestowrate,volumeanddrugconcentration
required to produce the desired result.
1.4 ProductDescription
1.4.1 ProductOverview
Ifanyoftheacronymsorwordsarenotunderstood,seetheDenitionsgiveninSection1.1.
The ambIT
®
PIB v1.5 pumps are unique pumps. There are three different modes of operation.
TherstmodeisPCA.ThesecondmodeisPIb4. The third mode is PIb and PCA (P+P). The
threedifferentmodesallowforthefollowingvetypesofinfusionpatterns:(1)basalowrate
only,(2)bolusonly,(3)basalowrateandbolus,(4)doseonly,(5)doseandbolus.
InPCAmode,thepumpcanbeprogrammedinbasalowratemode,bolusonly,orbasalow
rateandbolus.InPCAmodetheparametersavailableare(1)basalowrate5, (2) bolus volume6,
(3) lockout time7, and (4) volume to be infused8.
The PIb mode is added to simplify programming a dose-only therapy. Therefore, in PIb mode
the pump can only be programmed to deliver doses. The programmed parameters available in
PIb mode are (1) dose volume, (2) dose interval and (3) volume to be infused.
In P+P mode, the pump can be programmed to deliver a dose only, a bolus only, or a dose and
a bolus. The programmed parameters available are (1) dose volume9, (2) dose interval10, (3)
4 PIb stands for programmable intermittent boluses, but in order to avoid confusion, we refer to all automatically delivered
boluses as doses and PCA boluses as boluses.
5 Theunitsforthebasalowratearemilliliterperhour(ml/hr).When thebasalowrateissettozero(0.0)the PCA
program is set to bolus only.
6 The unit for the bolus volume is milliliter (ml). When the bolus volume is set to zero (0.0) the PCA program is set to basal
owrateonly.
7 Theunitsforthelockouttimearehoursandminutes(hh:mm).Thelockouttimeisbypassedautomatically if the bolus
volume is set to zero (0.0).
8 The volume to be infused unit is milliliter (ml). It is the reservoir volume. It is required to be programmed in all modes.
9 The dose volume unit is milliliter (ml). If it is set to zero (0.0), the interval time is bypassed automatically and the dose
volume can be set to bolus-only mode.
10 Thedoseintervalorintervalunitsarehoursandminutes(hh:mm).

Section 1 • Introduction
10
bolus volume11, (4) lockout time,(5) volume to be infused and, if a PIB-IL v1.5 pump, (6) interval
limit.
The goal of the bolus or dose is to infuse the medication at an increased rate — mimicking an
injectionasmuchaspossible.Thepurposeoftheincreasedrateisgenerallytooodagreater
areawithanalgesicmedicationortoincreasetheconcentrationofthemedication.Theowrate
at which the ambIT
®
PIB v1.5 pumps infuse a bolus or dose is dependent on the energy state of
the batteries.
The bolus/dose infusion rate will be 210 ml/hr until the low battery alarm is activated if a
new, unused set of AA alkaline batteries are used at the start of the infusion. After the low
battery alarm is activated, the bolus/dose infusion rate may be reduced from the 210 ml/hr to
about 180 ml/hr. On a new, unused set of alkaline batteries, the low battery alarm will not be
reached until at least 500 ml have been infused. If one or both batteries have been previously
used, non-alkaline batteries are used, or the pump is repeatedly cycled off and on, the bolus/
dose infusion rate may drop to a minimum of 125 ml/hr prior to the low battery alarm being
activated.Thepurposeofallowingtheinfusionratetodropistomaximizebatterylife.The
pump will NOT inform the user that the bolus/dose infusion rate has dropped. No other
parameters are affected as the batteries are depleted.
CAUTION: If the medication being infused requires the bolus/dose infusion rate to be 210
ml/hr, only new alkaline batteries should be used and the batteries should be
changed immediately when the low battery alarm occurs.
CAUTION: Repeatedly cycling the pump off and on may cause the bolus/dose infusion
ratetodropbelow210ml/hr.Inextremecases,thebolus/doseinfusionrate
could drop as low as 125 ml/hr.
A new, unused set of alkaline batteries will infuse at 210 ml/hr. For a minimum of 500 ml, the
bolusanddoseowratewillbe210ml/hr.Oncethebatterieshavebeendepleted,theowrate
maydecrease.Thelowestowratethepumpwillreachis125ml/hr.
The different parameters for each mode interact with each other to create an infusion pattern.
ExamplesoftheinfusionpatternsforthedifferentmodesareprovidedgraphicallyinFigures
1-1through1-6thatfollow.Theowrates,volumes,lockouttimes,andintervalslistedare
examplesonly.
11 If the bolus volume is set to zero (0.0), then the lockout time is automatically bypassed and the pump will only deliver
doses (like PIb mode).

Section 1 • Introduction
11
Figure1-1
Basalowrateonly(PCAmode)infusionpattern
ForFigure1-1,thebasalowrateis10ml/hr.Themaximumavailablebasalowrateis20ml.
Figure1-2
Bolusonly(PCAmode)infusionpattern
The settings for Figure 1-2 are a bolus volume of 10 ml and a lockout time of 30 minutes. After
a bolus is requested and delivered, a lockout time begins. A bolus is delivered only when the
BOLUS button or remote BOLUS switch is pressed. During the lockout time, the pump will
beep when a bolus is requested, but no bolus will be delivered.
CAUTION: Right after programming the pump or clearing history, a bolus will be delivered
if requested. The pump assumes that clearing history or programming/
reprogramming a new therapy is starting.
Basal
165
Time (Minutes)
180
195
210
235
240
0
150
135
Flowrate (ml/hr)
75
90
105
120
0
15
30
45
60
10

Section 1 • Introduction
12
Figure1-3
Basalowrateandbolus(PCAmode)infusionpattern
ForFigure1-3,thesettingsareabasalowrateof10ml/hr,abolusvolumeof10ml,anda
lockout time of 30 minutes
NOTE: Thebasalowrateisdiscontinuedwhileabolusisbeingdeliveredandresumes
once the bolus has been completed.
Figure1-4
Doseonly(PIbmode)infusionpattern
The settings for Figure 1-4 are a dose volume of 25 ml and a dose interval of 90 minutes.
NOTE: An optional dose can be delivered at the start of an infusion by pushing the
BOLUS button within 60 seconds of the start of an infusion.

Section 1 • Introduction
13
Figure1-5
Doseandbolus(P+Pmode)infusionpattern(doesnotapplytothePIB-IL v1.5)
Bolusesareavailableafteralockouttime.IntheexampleusedinFigure1-5andFigure1-6,
the dose volume is 20 ml, the dose interval is 90 minutes, the bolus volume is 10 ml, and the
lockout time is 30 minutes.
Automated doses are scheduled at a set interval. An optional dose is available at the start of
a new infusion if the BOLUS button is pushed within 60 seconds. Unlike in PCA mode, if the
BOLUSbuttonisnotpushed,thebolusisNOTavailableuntilthelockouttimehasexpired.
If a bolus is requested and delivered, the lockout time may delay the dose until the lockout
timehasexpired.Alockouttimeoccursimmediatelyaftereitherabolusordose12. The third
doseinFigure1-5hasbeendelayedbyalittleoverveminutes,soinsteadofoccurringatthe
180-minute mark, the third dose occurs at about the 185-minute mark. The dose stays delayed
for the rest of the therapy.
NOTE: Figure 1-5 does not apply to the PIB-IL v1.5pump;seeFigure1-7andFigure1-8
for PIB-IL v1.5 P+P infusion pattern.
12 Thepurposeofthelockouttimeistwo-fold:(1)toallowthemedicationtoworkbeforethepatientcanreceiveadditional
medication and (2) to space out doses and boluses to prevent the patient receiving a harmful amount of medication.

Section 1 • Introduction
14
Figure1-6
Doseandbolus(P+Pmode)infusionpatternofmultipledosedelays (doesnotapplytothe
PIB-IL v1.5)
Each time a dose is delayed, it is added to the previous delays. In Figure 1-6, the second dose
isdelayedbyabout10minutes(rstdosedelay),from90minutesto100minutes.Thismeans
that the third dose should have occurred at 190 minutes, but due to the second delay of a little
over 5 minutes (second dose delay), the third dose occurs at a little over 195 minutes. If no
otherdelaysoccur,thenalltheremainingdoseswillbedelayedbythesumoftherstand
second dose delays, or a little over 15 minutes.
NOTE: Figure 1-5 does not apply to the PIB-IL v1.5pump;seeFigure1-7andFigure1-8
for PIB-IL v1.5 P+P infusion pattern.

Section 1 • Introduction
15
Figure1-7
Doseandbolus(P+Pmode)infusionpatternofmultipleboluses
(Figure1-7onlyappliestothePIB-IL v1.5pump)
As shown in Figure 1-7, the total volume infused during the interval is reset to zero at the
beginning of each interval. As each bolus and dose is delivered, the total volume infused during
the interval is increased (see bold line). If the volume infused during the interval reaches the
interval limit (See Figure 1-8) or bolus delivery would overlap the end of a dose interval (See
Figure 1-7), then the bolus is stopped immediately.
NOTE: The undelivered portion of the bolus will not be delivered later.
Time
Time
Volume per interval (ml)
Flowrate (ml/hr)
Dose interval
Dose interval
Bolus
Dose
Partial bolus
Bolus
Dose
Lockout Time Lockout Time
Lockout Time
Interval Limit
Bolus delivery is stopped
and Dose delivery is started
because a new interval is
started. Undelivered bolus
volume is not made up.
Total Volume
Infused during
Dose Interval is
reset to zero at
the beginning of
the dose interval.
Total Volume
Infused during
Dose Interval
increases as bolus
or dose is
delivered.
Total Volume
Infused during
Dose Interval is
reset to zero at
the beginning of
the dose interval.
Total Volume
Infused During the
Dose Interval.

Section 1 • Introduction
16
NOTE: The total volume is controlled by the IL over the dose interval. This means it is
possible for the bolus and dose to be delivered back-to-back (i.e., the bolus at the
endofonedoseintervalandthedoseatthestartofthenextdoseinterval).
NOTE: Fromthestartofonedosetothestartofthenextdose(doseinterval),theIL
is maintained, but over a time that covers the end of one dose interval and the
startofthenextdoseinterval,thevolumesetfortheILmaybeexceeded.(This
situation is shown in Figure 1-7. The total volume infused from the time the
bolusisstartedattheendoftherstdoseintervaltothetimeattheendofthe
rstbolusintheseconddoseinterval,mayexceedtheIL.SeeFigure1-8below.)
Time
Time
Flowrate (ml/hr)Volume per interval
Lockout Time
Dose interval
Dose interval
Bolus
Lockout
Time
Dose
Partial bolus
Bolus
Dose
Lockout
Time
Lockout
Time
Interval limit
Interval
limit
Total Volume Infused
during Dose Interval is
reset to zero at the
beginning of the dose
interval.
Total Volume Infused
during Dose Interval is
reset to zero at the
beginning of the dose
interval.
Bolus delivery is stopped
because IL has been
reached.
Figure1-8
(Figure1-8onlyappliestothePIB-IL v1.5 pump)