Ambit PIB v1.5 - Product Description

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