Summit Medical ambIT User manual

.
MORE THAN PAIN RELIEF...
SUPERIOR PAIN CONTROL
CLINICIAN MANUAL
ambIT®Pump
0459
IP22

Become familiar with the ambIT
®
pump
.
Solution container
Tubing
clamp
BOLUS
button
ambIT
®
Pump
ON/OFF
switch
Remote BOLUS Switch
(optional for select models)
Tubing
clamp
Pump display
RUN/PAUSE button
Cassette
To solution container
(Side view of cassette)
Cassette shaft
To patient
Continuous pumps have
FUNCTION button in
place of BOLUS button

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 ..............................................8
1.2.2 Protection From Air Infusion.....................................................................................8
1.2.3 Protection From Unintended Bolus ..........................................................................8
1.2.4 Use of ambIT®Pump in MRI Environment .............................................................8
1.3 Indications for Use.................................................................................................................9
1.3.1 Continuous Pumps......................................................................................................9
1.3.2 PreSet Pumps ...............................................................................................................9
1.3.3 PCA Pumps ..................................................................................................................9
1.3.4 PreSet*PCA Pump .......................................................................................................9
1.4 Overview.................................................................................................................................9
1.4.1 Continuous Pumps....................................................................................................10
1.4.2 PreSet Pumps .............................................................................................................10
1.4.3 PCA Pumps ................................................................................................................10
1.5 Infusion Patterns..................................................................................................................11
SECTION 2 - SET UP .........................................................................................................................13
2.1 Required Materials ..............................................................................................................13
2.2 ambIT
®
Cassette ...................................................................................................................14
2.3 Priming the Cassette ...........................................................................................................14
2.4 Attach Cassette to the Pump..............................................................................................17
2.5 Remove Cassette from the Pump......................................................................................18
2.6 Changing the Fluid Reservoir............................................................................................18
2.7 Battery Installation and Replacement...............................................................................18
2.7.1 Battery Installation ....................................................................................................19
2.7.2 Battery Replacement .................................................................................................19
2.8 Pump Power On and Off....................................................................................................20
SECTION 3 - PROGRAMMING INSTRUCTIONS ....................................................................21
3.1 General Information............................................................................................................21
3.2 ambIT®Pump User Interface .............................................................................................22
3.3 Program Options .................................................................................................................23
3.4 Continuous Pump Programming Steps ...........................................................................23
3.5 PreSet Pump Programming Options ................................................................................24
3.6 PCA Pump Programming Steps........................................................................................29
3.7 Program Review...................................................................................................................31
SECTION 4 - OPERATING INSTRUCTIONS .............................................................................32
4.1 Start Infusion........................................................................................................................32
4.2 Pause Infusion......................................................................................................................33
4.3 Resume Infusion ..................................................................................................................33
4.4 Silence Alarm .......................................................................................................................33
4.5 Bolus Activation...................................................................................................................34
4.5a FUNCTION Button Activation..........................................................................................34
4.6 Summary of Operating Controls for Continuous Pumps .............................................35
4.7 Summary of Operating Controls for PreSet and PCA Pumps......................................35

ii
SECTION 5 - INFUSION HISTORY REPORTS...........................................................................36
5.1 Pump Infusion History.......................................................................................................36
5.2 Clearing Pump Infusion History.......................................................................................37
SECTION 6 - PATIENT LOCKOUT ...............................................................................................38
6.1 Accessing Lockout Mode....................................................................................................38
6.2 To Lock the Pump................................................................................................................38
6.3 To Unlock the Pump ...........................................................................................................39
SECTION 7 - ALARMS AND SIGNALS .......................................................................................40
SECTION 8 - TROUBLESHOOTING.............................................................................................42
SECTION 9 - SPECIFICATIONS.....................................................................................................43
9.1. GeneralSpecicationsApplicabletoAllPumps ............................................................43
9.2. ContinuousPumpSpecications ......................................................................................43
9.3. PreSetandPCAPumpSpecications...............................................................................44
SECTION 10 - DELIVERY RATE ACCURACY............................................................................45
10.1 Data from Volumetric Accuracy Testing .........................................................................46
10.2 Factors That May Affect Volumetric Accuracy...............................................................47
SECTION 11 - GENERAL CARE INSTRUCTIONS....................................................................51
11.1 Warranty Information.........................................................................................................51
11.2 Cleaning and Disinfecting Instructions............................................................................52
SECTION 12 - ELECTROMAGNETIC IMMUNITY (EMC) ......................................................53
SECTION 13 - CUSTOMER ASSISTANCE ..................................................................................55

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.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). Not available on Continuous pumps.
BOLUSFLOWRATE:Theowrateatwhichabolusisdelivered.Itisahigherowratethan
thebasalowrate.IntheambIT®pump,thebolusowrateiseither100ml/hror125ml/hr
(pumpmodeldependant).Thebolus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.
LOCKOUT TIME: The time between the end of one bolus and the start of the next bolus. 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.
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).
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 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 Thebolusisdeliveredatahigherowratethanthebasalrate;therefore,foragivenvolume,thebolusisdeliveredfaster.

Section 1 • Introduction
2
1.1.2 DenitionofSymbols1.1.2 DenitionofSymbols
Consult instructions for use.Consult instructions for use.
International symbolInternational symbol meaningmeaning “Attention, consult accompanying“Attention, consult accompanying
documents.”documents.”
IEIEC symbol for “Type BF Applied Part.” (C symbol for “Type BF Applied Part.” (IECClassication:InternallyIECClassication:Internally
powered.)powered.)
TThehe ambIT® pump complies with ES 60601-1:2012, 1st Edition,ambIT® pump complies with ES 60601-1:2012, 1st Edition,
includingAmend.1;CSAC22.2NO.60601-1:2014,3rdEdition;IEC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60601-1-60601-1:2005,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;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,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,2014-1stEdition,andAmend.1:2014;IEC60601-1-2:2014,4thEdition,2014-
02.02.
CE symbolCE symbol certifyingcertifying that the product complies with the essentialthat the product complies with the essential
requirements of the Medical Device Directive.requirements of the Medical Device Directive.
The“NRTL/C”indicatoradjacenttotheCSA(CanadianStandardsThe“NRTL/C”indicatoradjacenttotheCSA(CanadianStandards
Association)marksigniesthattheproducthasbeenevaluatedAssociation)marksigniesthattheproducthasbeenevaluated
to the applicable ANSI/UL and CSA standards for use in the U.S.to the applicable ANSI/UL and CSA standards for use in the U.S.
and Canada. NRTL (Nationally Recognized Testing Laboratory) isand Canada. NRTL (Nationally Recognized Testing Laboratory) is
a designation granted by the U.S. Occupational Safety and Healtha designation granted by the U.S. Occupational Safety and Health
Administration (OSHA) to laboratoriesAdministration (OSHA) to laboratories thatthat have been recognized tohave been recognized to
performcerticationtoU.S.standards.performcerticationtoU.S.standards.
The cUL mark applies to products intended for the Canadian market
that have been tested and found to comply with the requirements of
CAN/CSA 22.1-12, which is the Canadian Electrical Code issued by the
Canadian Standards Association.
ProtectedagainstinsertionofngersandwillnotbedamagedorProtectedagainstinsertionofngersandwillnotbedamagedor
become unsafe during a specbecome unsafe during a speciedtestinwhichitisexposedtoiedtestinwhichitisexposedto
vertically or nearly vertically dripping water.vertically or nearly vertically dripping water.
IP22

Section 1 • Introduction
3
Indicatesthemedicaldevicemanufacturer,asdenedinEUDirectivesIndicatesthemedicaldevicemanufacturer,asdenedinEUDirectives
90/385/EEC, 93/42/EEC and 98/79/EC.90/385/EEC, 93/42/EEC and 98/79/EC.
Indicates the Authorized Representative in the European Community.Indicates the Authorized Representative in the European Community.
Any natural or legal person established within the Union that places a
device from a third country on the Union market.
Medical device
Indicates the date after which the medical device is not to be used.Indicates the date after which the medical device is not to be used.
Indicates the manufacturer’s batch code or lot number so that the batchIndicates the manufacturer’s batch code or lot number so that the batch
orlotcanbeidentied.orlotcanbeidentied.
Indicatesthemanufacturer’sserialnumbersothataspecicmedicalIndicatesthemanufacturer’sserialnumbersothataspecicmedical
devicecanbeidentied.devicecanbeidentied.
SinSingle-use only (cassettes)gle-use only (cassettes)
KKeep away from heateep away from heat
KKeep dryeep dry
CaCaution:ution: This device is restricted to sale by or on the order of aThis device is restricted to sale by or on the order of a
physician.physician.
TeTemperature limitationmperature limitation

Section 1 • Introduction
4
SteSterilized using irradiationrilized using irradiation
DEHP-freeuidpathDEHP-freeuidpath
NoNot made with natural rubber latext made with natural rubber latex
IndIndicates which tubing connects toicates which tubing connects to
the solution containerthe solution container
IndIndicates which tubing connects toicates which tubing connects to
the patientthe patient
BBolusolus
ProProgram lockoutgram lockout
BBolus lockout time in hours:minutesolus lockout time in hours:minutes
BoBolus volume in milliliterslus volume in milliliters
VoVolume in milliliterslume in milliliters
BasBasal infusion rate in ml/hral infusion rate in ml/hr
NumNumber of boluses deliveredber of boluses delivered
Number of bolus requestsNumber of bolus requests
To patient
To solution container
Cassette
shaft
(side view of cassette)

Section 1 • Introduction
5
Elapsed timeElapsed time
VolumVolume to be infusede to be infused
RRUN/PAUSE buttonUN/PAUSE button
BOBOLUS buttonLUS button
FUNCTION buttonFUNCTION button
LowLow/dead battery indicator/dead battery indicator
Alarm indicatorAlarm indicator
ambITambIT®pump displaypump display
PumPump power onp power on
Pump poPump power offwer off
BBattery orientationattery orientation
PrProgram lockout codeogram lockout code
ProgrProgram lockout modeam lockout mode

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.
PumpPump program modeprogram mode
Review pReview pump programump program
Infusion history reportInfusion history report
PumPump infusion history clearedp infusion history cleared

Section 1 • Introduction
7
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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.
Before starting therapy, check that all connections are secure and that there are no leaks in the
uidpath.
Aftertheinfusionisnished,thepumpwillgivetheinfusioncompletealarmandcontinue
infusing at a KVO rate. The rate is dependent on the basal rate programmed. If the basal rate is
0.5ml/hr or greater, the KVO will be 0.5 ml/hr. If the basal rate is less than 0.5 ml/hr, then the
KVO is the basal rate. The KVO is not programmable.

Section 1 • Introduction
8
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.
• If infusion of air could cause harm to the patient, the ambIT®pump should be used
withaireliminationltersbecauseairdetection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 (1) 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®PumpinMRIEnvironment
Safety in MRI not evaluated. The ambIT®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®pumps
in the MRI environment is unknown. Scanning a patient who has this device may
resultinpatientinjury

Section 1 • Introduction
9
1.3 IndicationsforUse
1.3.1 ContinuousPumps
The ambIT®Continuous pumps are intended for continuous volumetric delivery of intravenous
medicinesand/oruidsintopatientsataconsistentvolumeforprescriptivetreatmentbya
physician.
1.3.2 PreSetPumps
The ambIT®pumps with PreSet settings are intended for use by surgeons and anesthesiologists
for the peri-operative and post-operative infusion of local anesthetics and narcotics for
pain management and regional anesthesia. Routes of administration include intravenous,
subcutaneous, intramuscular, perineural and epidural. The ambIT®pumps with PreSet settings
arealsointendedtosignicantlydecreasenarcoticuseandpainwhenusedtodeliverlocal
anesthetics to surgical wound sites or in close proximity to nerves when compared with
narcotic only pain management.
1.3.3 PCAPumps
The ambIT®PCApumpisusedtoinfusemedicinesand/oruidsintopatientsforpain
management. Modes of action are intravenous, epidural and/or regional.
1.3.4 PreSet*PCAPump
The ambIT®PreSetPCApumpisusedtoinfusemedicinesand/oruidsintopatientsfor
pain management. The routes of administration are intravenous, epidural, nerve blocks, and/
orlocalinltration.TheambIT® PreSet*PCA pump is not intended to supersede, augment or
replace any other medical device or drug indications for use or intended uses. The ambIT®
PreSet*PCA pump is intended to be used in the home and in healthcare facilities. The ambIT®
PreSet*PCA pump is intended to be used by patients 12 years old and above.
1.4 Overview
The ambIT
®
familyofpumpsaredesignedfortheambulatoryinfusionofuidsand
medications in home and healthcare facilities. The pumps have simple controls that are easily
operated by both caregivers and patients. References to the remote BOLUS switch apply only
to pumps with the remote BOLUS port. See the diagram on inside front cover to determine if
pump has a remote BOLUS switch option. The operator position with respect to the device is
considered arms length (no more than 0.5 meters direct view).
Ifanyoftheacronymsorwordsarenotunderstood,seetheDenitionsgiveninSection1.1.
There are three categories of ambIT
®
pumps within this manual: Continuous, PreSet and PCA.
Continuous pumps allow for continuous infusion. The PreSet category of pumps contain up to
veprogrammingoptionsonthebackofthepumpandintheprogrammingsteps.Allother
pumps are PCA pumps. Below are descriptions of these three pump types. See Section 10 for
individualpumpspecications.

Section 1 • Introduction
10
NOTE: Any use of the ambIT
®
pump other than those indicated in this manual is
regarded as an off-label use. The ambIT
®
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.
NOTE: SummitMedicalProducts,Inc.doesnotrecommendorendorseanyonespecic
medication to be used with the ambIT
®
family of pumps. The healthcare
provider is the sole individual who decides upon the prescribed medication,
programmed pump 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.
1.4.1 ContinuousPumps
The ambIT®Continuousfamilyofpumpsallowonlycontinuousowrates(i.e.,basalonlyow
rates). These pumps contain no bolus feature.
1.4.2 PreSetPumps
The ambIT®PreSet family of pumps allow for the following three types of infusion patterns: (1)
basalowrateonly,(2)bolusonly,and(3)basalowrateandbolus.
These pumps simplify pump programming by providing the clinician with the option to choose
from up to four (4) preprogrammed infusion protocols (PRO1 - PRO4), or to program infusion
parameters individually (PRO5).
NOTE: Some ambIT®pumps with PreSet settings have a limited life of 2,000 ml total
infusion. Once 2,000 ml has been reached, the pump will continue to infuse
uninterrupted as programmed, until the current infusion program is complete.
After the infusion beyond 2,000 ml has been completed, the next time the pump
is powered on the ALARM icon ( ) and “EEE” will appear in the display,
indicating that the pump has reached its end of life and must be replaced.
1.4.3 PCAPumps
The ambIT®PCA pumps do not include PreSet settings. The clinician may select different
deliveryproles,whichinclude:(1)basalowrateonly,(2)bolusonly,and(3)basalowrate
and bolus.

Section 1 • Introduction
11
1.5 InfusionPatterns
The different parameters of an infusion interact with each other to create an infusion pattern.
Examples of the infusion patterns are provided graphically in Figures 1-1 through 1-3 that
follow.Theowrates,volumesandlockouttimesdiscussedinthegraphsareexamplesonly.
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
Figure1-1
Basalowrateonlyinfusionpattern-applicabletoallpumps
ForFigure1-1,thebasalowrateis10ml/hr.Themaximumavailablebasalowrateis20
mlforPreSetsandPCApumps.Themaximumavailablebasalowrateis125ml/hrfora
Continuous pump.
Figure1-2
Bolusonlyinfusionpattern-notapplicabletoContinuouspumps
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: After programming the pump or clearing the history, a bolus will be delivered,
if requested, within one minute. The pump assumes that clearing history or
programming/reprogramming indicates that a new therapy is starting.

Section 1 • Introduction
12
Figure1-3
Basalowrateandbolusinfusionpattern-notapplicabletoContinuouspumps
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.
WARNING: Aftertheinfusionisnished,thepumpwillgivetheinfusioncompletealarm
and continue infusing at a KVO rate. The rate is dependent on the basal rate
programmed. If the basal rate is 0.5 ml/hr or greater, the KVO will be
0.5 ml/hr. If the basal rate is less than 0.5 ml/hr, then the KVO is the basal rate.
The KVO rate is not programmable.
NOTE: Thebasalowrateisdiscontinuedwhileabolusisbeingdeliveredandresumes
once the bolus has been completed.

Section 2 • Set Up
13
SECTION 2 - SET UP
(See diagram on inside front cover)
The following steps must be accomplished sequentially to properly set up the pump:
1. Gatherrequiredmaterials(seeSection2.1);
2. Installnew,unused,AAalkalinebatteries(seeSection2.7);
3. Programthepump(seeSection3);
4. Primethecassette(seeSection2.3);
5. Verify that the cassette bottom disc is snapped closed before attaching the cassette to the
pump (see Section 2.2).
6. Attachthecassettetothepump(seeSection2.4);
7. Attach the long tubing of the cassette to the patient catheter
usingtheaseptictechniqueutilizedbyyourfacility;
8. Startinfusion(seeSection4.1);and,
9. Ensure the patient is instructed in the use of the pump and receives a patient manual.
WARNING: Protection from air infusion - The infusion solution must be provided in a non-
vented, collapsible container. Remove all air from solution container and tubing
before use.
NOTE: It is the responsibility of the healthcare provider to ensure that the lay user/
patient is educated in the proper use of the pump.
NOTE: It is the responsibility of the healthcare provider to modify any guidelines
provided to the lay user/patient along with the pump as appropriate for the
individual patient’s clinical status and medication provided.
2.1 RequiredMaterials
The ambIT®cassette is a sterile, disposable (single-use) administration set. The upstream (short)
tubing of the cassette connects to a non-vented, collapsible solution container. Once the cassette
has been primed, the downstream extension (long) tubing of the cassette connects to the
patient’s access device.
Contact Summit Medical Products, Inc. to obtain a complete list of cassettes.
Accessories such as MediBag™ solution containers and carrying pouches may be added as
required by the therapy. Contact Summit Medical Products, Inc. to obtain a complete listing of
all optional accessories.

Section 2 • Set Up
14
The cassette contains a rotary mechanism that pumps the infusion
solution at an accurate and controlled rate.
Duringcassettepriming,uidwillowfreelythroughthetubing(Figure
1).
After priming, snap the cassette bottom disc into the body of the cassette
toclosetheuidpath. This prevents, thefreeowofuid(Figure2).
When primed, the cassette simply snaps onto the pump.
WARNING: Ifaninfusionofaircouldcauseharmtothepatient,anaireliminationlter
should be used. The ambIT
®
cassette may be ordered with or without an
integratedaireliminationlter.
WARNING: The ambIT
®
pump requires the use of an ambIT
®
cassette. Use of cassettes
not manufactured by Summit Medical Products, Inc. may cause the pump to
malfunction and may cause an over-infusion or an under-infusion.
NOTE: If an ambIT
®
cassettealreadyhasalter,itisnotrecommendedtouseaseparate
aireliminationlter.Usingasecondltermaycausethepressuretoexceedthe
activation pressure for the pressure switch, causing an occlusion alarm (“OCL”
in display and a constant beep).
2.2 ambIT
®
Cassette
WARNING: Freeowwilloccuruntilthecassettebottomdiscissnappedinplace.No
alarm will sound if the cassette bottom disc is not snapped in place. Do not
attach the cassette to the patient until the cassette is placed on the pump or the
cassette bottom disc is snapped into place. Placing the cassette on the pump will
automaticallysnapthediscinplaceandpreventfreeow.
NOTE: Once the cassette bottom is snapped into place, the rollers engage and compress
thetubing,preventinguidfromowingunlessthepumpisrotatingand
movingtheuid.Ifadownstreamocclusionoccurs,thepumpwillalarmand
notify the user.
2.3 PrimingtheCassette
WARNING: Do not use a cassette if the outer package is torn, punctured, wet or damaged.
Do not touch the sterile open ends of the tubing. Use the aseptic technique
utilized by your facility.
Figure1
Figure2
Top view of cassette
Cassette bottom disc (clear)

Section 2 • Set Up
15
Step #1 Remove the protective cover from the bottom of the
cassette (see illustration at left).
Step #2 Connect the solution container to the short tubing of
the cassette using the aseptic technique utilized by your
facility.
Step #3 Release all clamps on the tubing.
Step #4 Invert the solution container to allow air to be evacuated
beforeprimingthecassettewithuid(seeillustrationat
left).
Step #5 Gentlysqueezethesolutioncontainertoforceuidand
air upward through the tubing and cassette. Continue
untilthesolutionhascompletelylledthetubingandall
air bubbles have been removed.
Step #6 Afterpriming,closetheuidpathbysnappingthe
cassette bottom disc into the cassette body. This will
preventfreeow.
WARNING: The cassette must be primed before use by removing all air from the solution
container and tubing.
WARNING: Do not connect the cassette to the patient until the cassette has been primed, the
cassette has been connected to the pump, and the pump has been programmed
to the desired therapy and checked per hospital protocol.
CAUTION: Verify that all connections are secure, all clamps are opened, and that there are
noleaksintheuidpathbefore starting therapy.
If thelledsolutioncontainerisnotgoingtobeusedimmediately,clampthetubingandcap
the connector with the protective cap provided to prevent contamination.
Always verify that the cassette bottom disc is snapped closed before attaching the cassette to
the pump.
Toprimethecassette,followthesesteps:
Protective cover

Section 2 • Set Up
16
WARNING: Failure to properly snap the cassette bottom disc into the cassette body may
resultinincorrectowratesorfree-owconditions. Placing the cassette on the
pump will snap the cassette disc bottom in place, if it is not done prior.
NOTE: If the cassette bottom disc is snapped closed before the priming process is
complete, place the cassette onto the pump (not attached to the patient) and use
the instructions below to complete the priming of the cassette.
ToremovetheairfortheContinuouspumps,completeSteps6aand6b,asfollows:
Step #6a Set the pump to infuse at 125 ml/hr (see Section 3.4.).
Step #6b Start the infusion (see Section 4.1). Once all the air has been removed from the
cassettetubinganduidreservoir,stopthepumpbypausingtheinfusion(see
Section 4.2).
Oncealltheairhasbeenremovedfromthecassettetubinganduidreservoir,
pause the infusion, clear the history and program the pump to the desired
settings.
ToremovetheairusingtheBOLUSbuttonforthePreSetandPCApumps,completeSteps
6aand6b,asfollows:
Step #6a Program the pump to deliver a 20 ml bolus (see Section 3.5 for PreSet pumps or
3.6 for PCA pumps).
Step #6b Start the infusion (see Section 4.1) and press the BOLUS button (see Section 4.5)
Oncealltheairhasbeenremovedfromthecassettetubinganduidreservoir,
stop the pump by placing it in pause (see Section 4.2).
If necessary to remove more than 20 ml of air from the solution container and
tubing, boluses can be repeated quickly by clearing the history between each
bolus (see Section 5.2).
Oncealltheairhasbeenremovedfromthecassettetubinganduidreservoir,
clear the history and program the pump to the desired settings.