AbbVie VYAFUSER - Introduction; Warnings and Cautions

5Introduction
Warnings and Cautions
1. Introduction
The VYAFUSER pump is an ambulatory infusion pump that uses single-
use syringes for the controlled subcutaneous administration of VYALEV
(foscarbidopa and foslevodopa). It provides continuous infusion
24 hours a day, 7 days a week. It administers VYALEV subcutaneously
through an infusion set, which is an applied part (where system
physically connects to the body). The exterior surfaces of the pump
have been tested as a Type BF applied part.
Instruct the patient to keep a supply of backup oral Parkinson’s
Disease medicines with them at all times in case they are unable to use
VYALEV infusion.
Warning
This Healthcare Professional Instructions for Use of
VYAFUSER Pump is intended to be used only by a qualied
healthcare professional trained on the use of this system.
Only use the delivery system in a manner described in this
Instructions for Use.
Only use VYALEV and the VYAFUSER pump with disposable
components that have been qualied for use with this system.
Qualied components can be found at: devices.abbvie.com. This
includes the vial adapter, infusion set (inserter, cannula and tubing),
and syringe. The use of unqualied components may lead to allergic
reaction, infection, or improper function.
Cautions
• After programming the pump for use and prior to dispensing the
pump to the patient, always verify through visual inspection that all
parameter settings have been set correctly. Incorrect settings may
result in unintended results.
• To prevent unauthorized users from changing settings:
• Do NOT distribute a copy of the Healthcare Professional
Instructions for Use of VYAFUSER Pump to a patient or
caregiver.
• Do NOT give the pump to patient/caregiver until you have
exited clinician settings.
1.1 Warnings and Cautions