Summit Medical ambIT User manual

®
.
0088
0459
MORE THAN PAIN RELIEF...
SUPERIOR PAIN CONTROL
CLINICIAN MANUAL
ambIT®PIB Pumps
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 Definitions and Symbols.......................................................................................................1
1.1.1 Definitions ....................................................................................................................1
1.1.2 Definition of Symbols..................................................................................................2
1.2 Warnings.................................................................................................................................7
1.2.1 Sterile, Disposable (Single-Use) Administration Set ..............................................8
1.2.2 Protection From Air Infusion.....................................................................................8
1.2.3 Protection From Unintended Bolus ..........................................................................9
1.2.4 Use of ambIT
®
PIB Pumps in MRI Environment ....................................................9
1.3 Indications for Use.................................................................................................................9
1.4 Product Description ............................................................................................................10
1.4.1 Product Overview .....................................................................................................10
1.4.2 ambIT
®
Pump User Interface ...................................................................................18
1.4.3 ambIT
®
Cassette .........................................................................................................18
SECTION 2 - SET UP .........................................................................................................................20
2.1 Required Materials ..............................................................................................................20
2.2 ambIT
®
Cassette ...................................................................................................................21
2.3 Priming the Cassette ...........................................................................................................21
2.4 Attach Cassette to Pump ....................................................................................................24
2.5 Remove Cassette from Pump.............................................................................................24
2.6 Changing Fluid Reservoir ..................................................................................................25
2.7 Battery Installation and Replacement...............................................................................25
2.7.1 Battery Installation ....................................................................................................25
2.7.2 Battery Replacement .................................................................................................26
2.8 Pump Power On and Off....................................................................................................27
SECTION 3 - PROGRAMMING INSTRUCTIONS ....................................................................28
3.1 General Information............................................................................................................28
3.2 Program Options .................................................................................................................29
3.2.1 PCA Mode ..................................................................................................................29
3.2.2 PIb Mode.....................................................................................................................34
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 .......................................................................................................................45
4.5 Bolus Activation...................................................................................................................45
4.6 Summary of Operating Controls.......................................................................................46

ii
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
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 12 - ELECTROMAGNETIC IMMUNITY (EMC) ......................................................65
SECTION 13 - CUSTOMER ASSISTANCE ..................................................................................67

Section 1 • Introduction
1
SECTION 1 - INTRODUCTION
1.1 Definitions and Symbols
1.1.1 Definitions
ANALGESIA: Relief from pain.
BASAL FLOW RATE: The continuous flow rate. It occurs when the pump is not delivering
a bolus in PCA mode. The basal flow 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.
1
The bolus
is infused at the bolus flow 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 flow rate at which a bolus or dose is delivered. It is a
higher flow rate than the basal flow rate. In the ambIT
®
PIB pumps, the bolus flow 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 flow rate. See Section 1.4.1 for an explanation of how the bolus flow
rate changes. The bolus/dose flow 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 time
2
and 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, or, if there is no dose programmed, it is the maximum bolus volume allowed to be
programmed. This setting is only applicable to PIB + PCA (“P+P”) mode for PIB-IL 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 flow rate than the basal rate; therefore, for a given volume, the bolus is delivered faster.
2 The dose is delivered at a higher flow 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 fluid 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 are found at Section 1.2, as well as throughout this document emphasized
with grey shading. Failure to observe a warning message is potentially life threatening.
1.1.2 Definition of Symbols
Consult instructions for use.
International symbol meaning “Attention, consult accompanying
documents.”
IEC symbol for “Type BF Applied Part.” (IEC Classification: 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 60601-1-11:20105; 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.
CE symbol certifying that the product complies with the essential
requirements of the Medical Device Directive.
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.
0088
®

Section 1 • Introduction
3
The “NRTL/C” indicator adjacent to the CSA (Canadian Standards
Association) mark signifies that the product has been evaluated to the
applicable ANSI/UL and CSA standards for use in the U.S. and Canada.
NRTL (Nationally Recognized Testing Laboratory) is a designation
granted by the U.S. Occupational Safety and Health Administration
(OSHA) to laboratories that have been recognized to perform
certification to U.S. standards.
Underwriters Laboratories (UL) symbol certifying that the product
meets OSHA required safety standard.
Protected against insertion of fingers and will not be damaged or
become unsafe during a specified test in which it is exposed to vertically
or nearly vertically dripping water.
Indicates the medical device manufacturer, as defined in EU Directives
90/385/EEC, 93/42/EEC and 98/79/EC.
Indicates the Authorized Representative in the European Community.
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
identified.
Indicates the manufacturer’s serial number so that a specific medical
device can be identified.
Single-use only (cassettes)
Keep away from heat
IP22

Section 1 • Introduction
4
Keep dry
Caution: This device is restricted to sale by or on the order of a
physician.
Temperature limitation
Sterilized using irradiation
DEHP-free fluid path
Not made with natural rubber latex
Indicates which tubing connects to
the solution container
Indicates which tubing connects to
the patient
Bolus
Program lockout
To patient
To solution container
Cassette
shaft
(side view of cassette)

Section 1 • Introduction
5
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
Low/dead battery indicator
Alarm indicator
ambIT
®
pump display
Pump power on

Section 1 • Introduction
6
Pump power off
Battery orientation
PIb mode
PCA mode
P+P mode
Program lockout code
Program lockout mode
Pump program mode
Review pump program
Infusion history report
Pump infusion history cleared
Bolus button on
Bolus button off

Section 1 • Introduction
7
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.
This pump does not have an air in-line alarm. A cassette with an air elimination filter 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.

Section 1 • Introduction
8
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 modification 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 fluid delivery.
Before starting therapy, check that all connections are secure and that there are no leaks in the
fluid 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.
• 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.

Section 1 • Introduction
9
• For IV applications, the ambIT
®
PIB pumps should be used with air elimination
filters 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 fluid 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 Pumps in MRI Environment
Safety in MRI not evaluated. The ambIT
®
PIB pumps have not been evaluated for
safety and compatibility in the MRI environment. It has not been tested for heating,
migration, or image artifact in the MRI environment. The safety of the ambit PIB
pumps in the MRI environment is unknown. Scanning a patient who has this device
may result in patient injury.
1.3 Indications for Use
The ambIT
®
PIB pumps are used to infuse medicines and/or fluids into patients primarily for
pain management.
The routes of administration are generally intravenous, epidural, and/or regional.
The ambIT
®
PIB pumps are not intended to supersede, augment, or replace any other medical
device or drug indications for use or intended uses.
The ambIT
®
PIB pumps are intended to be used in the home and in healthcare facilities.
NOTE: Any use of the pump other than those indicated above is regarded as an off-
label use. The ambIT
®
PIB 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 filtered cassette or air elimination filter.
NOTE: Summit Medical Products, Inc. does not recommend or endorse any one specific
medication to be used with the ambIT
®
PIB pumps. The healthcare provider
is the sole individual who decides upon the prescribed medication, pump
programmed parameters, method and location of infusion.

Section 1 • Introduction
10
NOTE: The suitability of this product for use with any specific 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-specific 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 qualified nor
permitted to provide specific recommendations for treating any specific patient.
In general, to avoid complications, use the lowest flow 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 Definitions given in Section 1.1.
The ambIT
®
PIB pumps are unique pumps. There are three different modes of operation. The
first mode is PCA. The second mode is PIb
4
. The third mode is PIb and PCA (P+P). The three
different modes allow for the following five types of infusion patterns: (1) basal flow rate only,
(2) bolus only, (3) basal flow rate and bolus, (4) dose only, (5) dose and bolus.
In PCA mode, the pump can be programmed in basal flow rate mode, bolus only, or basal
flow rate and bolus. In PCA mode the parameters available are (1) basal flow rate
5
, (2) bolus
volume
6
, (3) lockout time
7
, (4) activation/deactivation of bolus button (KIDS
•
PIB pump only),
and (5) volume to be infused
8
.
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 volume
9
, (2) dose interval
10
, (3)
bolus volume
11
, (4) lockout time, (5) activation/deactivation of bolus button (KIDS
•
PIB pump
only), (6) volume to be infused and, if a PIB-IL pump, (7) interval limit.
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 flow rate are milliliter per hour (ml/hr). When the basal flow 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
flow 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).
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
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 flood a greater
area with analgesic medication or to increase the concentration of the medication. The flow rate
at which the ambIT
®
PIB pump infuses 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 flow rate will be 210 ml/hr. Once the batteries have been depleted, the flow rate
may decrease. The lowest flow 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 flow rates, volumes, lockout times, and intervals listed are
examples only.
NOTE: For the Australian PIB
•
PCA, the maximum average infusion rate is limited
to 20 ml/hr. While these graphs represent what occurs in all cases, the actual
program settings shown in examples may not be available in all models.

Section 1 • Introduction
12
Figure 1-1
Basal flow rate only (PCA mode) infusion pattern
For Figure 1-1, the basal flow rate is 10 ml/hr. The maximum available basal flow 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.
NOTE: When using the KIDS
•
PIB pump, the BOLUS button on the pump may be
activated to allow a bolus administration directly from the BOLUS button or
deactivated to require the use of a remote BOLUS switch to administer a bolus.
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
13
Figure 1-3
Basal flow rate and bolus (PCA mode) infusion pattern
For Figure 1-3, the settings are a basal flow rate of 10 ml/hr, a bolus volume of 10 ml, and a
lockout time of 30 minutes
NOTE: The basal flow 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. For the Australian
PIB
•
PCA, the optional dose is only available after the infusion history has been
cleared. When using the KIDS
•
PIB pump, the BOLUS button on the pump may
be activated to allow a bolus administration directly from the BOLUS button or
deactivated to require the use of a remote BOLUS switch to administer a bolus.

Section 1 • Introduction
14
Figure 1-5
Dose and bolus (P+P mode) infusion pattern
(PIB
●
PCA, KIDS
•
PIB and Australian PIB
•
PCA pumps only; does not apply to the PIB-IL)
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 dose
12
. The third
dose in Figure 1-5 has been delayed by a little over five 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 pump; see Figure 1-7 and Figure 1-8 for
PIB-IL P+P infusion pattern.
NOTE: When using the KIDS
•
PIB pump, the BOLUS button on the pump may be
activated to allow a bolus administration directly from the BOLUS button or
deactivated to require the use of a remote BOLUS switch to administer a bolus.
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
15
Figure 1-6
Dose and bolus (P+P mode) infusion pattern of multiple dose delays
(PIB
●
PCA, KIDS
•
PIB and Australian PIB
•
PCA pumps only; does not apply to the PIB-IL)
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 (first 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 first and second dose
delays, or a little over 15 minutes.
NOTE: Figure 1-6 does not apply to the PIB-IL pump; see Figure 1-7 for PIB-IL infusion
pattern of multiple dose delays.

Section 1 • Introduction
16
Figure 1-7
Dose and bolus (P+P mode) infusion pattern of multiple boluses
(Figure 1-7 only applies to the PIB-IL 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.
T
ime
T
ime
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.