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 DenitionsandSymbols.......................................................................................................1
1.1.1 Denitions ....................................................................................................................1
1.1.2 DenitionofSymbols..................................................................................................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 DenitionsandSymbols
1.1.1 Denitions
ANALGESIA:
Relief from pain.
BASAL FLOW RATE:
Thecontinuousowrate.Itoccurswhenthepumpisnotdelivering
abolusinPCAmode.Thebasalowrateisadjustableandhasunitsofmillilitersperhour
(ml/hr).
BOLUS:
A volume of medication infused over a relatively short period of time.1The bolus
isinfusedatthebolusowrate.Abolusisdeliveredwhenapatientrequestsitbypushingthe
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:
Theowrateatwhichabolusordoseisdelivered.Itis
ahigherowratethanthebasalowrate.IntheambIT
®
PIB v1.5 pumps,thebolusowrate
varies from 210 ml/hr to 125 ml/hr, depending on the energy left in the battery. Flow rate
accuracyisnotaffectedbythebolusowrate.SeeSection1.4.1foranexplanationofhowthe
bolusowratechanges.Thebolus/doseowrateisnotadjustable.
CAUTION:
A caution usually appears in front of a procedure or statement. Failure to
observeacautioncouldresultinseriouspatientoruserinjury.Cautionsarefoundthroughout
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
ofthenextdose.Thedoseintervalhasunitsofhoursandminutes(hh:mm).
INTERVAL LIMIT (“IL”): Themaximumamountthatcanbedeliveredwithinadoseinterval
andthemaximumbolusvolumeallowedtobeprogrammed.Thissettingisonlyapplicableto
PIB + PCA (“P+P”) mode for PIB-IL v1.5 pumps.
LOCKOUT TIME:
Thetimebetweentheendofonebolusordoseandthestartofthenext
bolusordose.Thelockouttimehasunitsofhoursandminutes(hh:mm).
NOTE:
Anotehighlightsinformationthatactsasareminderorhelpsexplainaconceptor
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 Thebolusisdeliveredatahigherowratethanthebasalrate;therefore,foragivenvolume,thebolusisdeliveredfaster.
2 Thedoseisdeliveredatahigherowratethanthebasalrate;therefore,foragivenvolume,thedoseisdeliveredfast.
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).3Withinthismanual,whenreferringtothepumpitself,“PIB”isused;whenreferring
to the dose, display or mode, “PIb” is used.
VOLUME TO BE INFUSED:
Thetotalamountofuidinthesolutioncontaineror
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 DenitionofSymbols
Consult instructions for use.
International symbol meaning “Attention, consult accompanying
documents.”
IECsymbolfor“TypeBFAppliedPart.”(IECClassication:Internally
powered.)
The ambIT
®
pumpcomplieswithES60601-1:2012,1stEdition,
includingAmend.1;CSAC22.2NO.60601-1:2014,3rdEdition;IEC
60601-1:2005,includingCorr.2:2007andAmend.1:2012;IEC60601-1-
6:2013,Edition3.1;IEC60601-1-8:2012,Edition2.1;IEC60601-1-11:2015;
60601-2-24:2012,Edition2;IEC62304:2006,1stEdition;IEC62366:2007,
1stEdition,andAmend.1:2014;IEC60601-1-2:2014,4thEdition,2014-
02.
Protectedagainstinsertionofngersandwillnotbedamagedor
become unsafe during a speciedtestinwhichitisexposedto
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
Indicatesthemedicaldevicemanufacturer,asdenedinEUDirectives
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
identied.
Indicatesthemanufacturer’sserialnumbersothataspecicmedical
devicecanbeidentied.
Single-use only (cassettes)
Keep away from heat
Keep dry
Caution:Thisdeviceisrestrictedtosalebyorontheorderofa
physician.
Temperature limitation
Sterilized using irradiation
DEHP-freeuidpath
Notmadewithnaturalrubberlatex
Section 1 • Introduction
4
Indicates which tubing connects to
the solution container
Indicates which tubing connects to
the patient
Bolus
Program lockout
Boluslockouttimeinhours: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.
Transportandstorageconditions:-25ºC(-13ºF)withoutrelativehumiditycontrol;and+70ºC
(+158ºF)atrelativehumidityofupto93%,non-condensing.
The pump will warm from the minimum storage/transportation temperature to room
temperature(about20ºC[68ºF])inapproximately30minutes.Thepumpwillcooltoroom
temperaturefromthemaximumstorage/transportationtemperatureinabout35minutes.
Operatingconditions:+5ºCto+40ºC(+41ºFto+104ºF);relativehumidityrangeof15%to93%,
non-condensing;andanatmosphericpressureof700hPato1060hPa(10.2psito15.4psi).
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
Table of contents
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