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

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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.