Section 1 • Introduction
9
NOTE:
Summit Medical Products, Inc. does not recommend or endorse any one specific
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 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
v1.5
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
, 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 flow rate are milliliter per hour (ml/hr).
When t
he 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).
