Ambit PIB v1.5 - Protection from Air Infusion; Protection from Unintended Bolus; Use of Ambit PIB V1.5 Pumps in MRI Environment; Indications for Use

Section 1 • Introduction
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• 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.
• For IV applications, the ambIT® PIB v1.5 pumps should be used with air elimination
ltersbecauseairprotection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 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
®
PIB·v1.5PumpsinMRIEnvironment
Safety in MRI not evaluated. The ambIT
®
PIB·v1.5 pumps have not been evaluated for
safety and compatibility in the MRI environment. The pumps have not been tested for
heating, migration, or image artifact in the MRI environment. The safety of the ambIT
®
PIB v1.5 pumps in the MRI environment is unknown. Scanning a patient who has the
devicemayresultinpatientinjury.
1.3 IndicationsforUse
The ambIT
®
PIB v1.5 pumps are usedtoinfusemedicinesand/oruidsintopatientsprimarily
for pain management.
The routes of administration are generally intravenous, epidural, and/or regional.
The ambIT
®
PIB v1.5 pumps are not intended to supersede, augment, or replace any other
medical device or drug indications for use or intended uses.
The ambIT
®
PIB v1.5 pumps are intended to be used in the home and in healthcare facilities.
NOTE: Any use of the pumps other than those indicated above is regarded as an off-
label use. The ambIT
®
PIB v1.5 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.