Bayer FFA 50 Mode D'emploi page 5

ENGLISH
Introduction
Read the information contained in this document.
Understanding the information will assist the user in operating
the device in a safe manner.
Important Safety Notice
This device is intended to be used by individuals with adequate
training and experience in diagnostic imaging studies.
Indications For Use
The contents of this package are intended to be used in the
delivery of contrast media. These devices are indicated for
single-use only with Injector Systems from Bayer.
Contraindications
These devices are not intended for multiple-use, drug infusion,
chemotherapy, or any other use for which the device is not
indicated.
Restricted Sale
Federal (USA) law restricts these devices for sale by or on the
order of a physician.
Report any serious incident that has occurred in relation to this
device to Bayer (radiology.bayer.com/contact) and to your local
European competent authority (or, where applicable, to the
appropriate regulatory authority of the country in which the
incident has occurred).

Warning
Air embolization can cause death or serious injury to the
patient. Do not connect a patient to the injector until all
trapped air has been cleared from the syringe and fluid path.
Carefully read the instructions for loading and the use of
MEDRAD® FluiDots indicators (where applicable) to reduce the
chance of air embolism.
Biological contamination can result from reusing
disposable items or failure to follow aseptic technique.
Properly discard disposable items after use.
Do not use if sterile package is opened or damaged.
Patient or operator injury may result if package is opened or
damaged, or if damaged components are used. Visually
inspect contents and package before each use.
For devices labeled for single use, please note: This
product is intended for single use only. Do not resterilize,
reprocess or reuse. The disposable devices have been
designed and validated for single use only. Re-use of the
single use disposable devices pose risks of device failure and
risks to the patient. Potential device failure includes
significant component deterioration with extended use,
component malfunction, and system failure. Potential risks to
the patient include injury due to device malfunction or
infection as the device has not been validated to be cleaned or
re-sterilized.

Caution
Component damage or leaks may occur if not installed
properly. Ensure all connections are secure; do not
overtighten. This will help minimize leaks, disconnection, and
component damage.
Transferring Fluid Using a Female/Female Adapter (FFA)
Use the FFA to load fluid from a prefilled syringe.
NOTE:
Prepare the Injector System for fluid delivery per
the instructions in the Injector System Operation
Manual.
NOTE:
Ensure that the fluid path is open.
1.
Remove the protective cover from the syringe luer tip.
2.
Attach a sterile Female/Female Adapter (FFA) onto the tip
of the syringe.
3.
Prepare the prefilled syringe by removing the protective
closure.
4.
Attach the prefilled syringe to the FFA.
5.
Follow the instructions contained in the Injector System
Operation Manual and syringe kit instructions For Use to
fill the syringe with Fluid from the prefilled syringe and to
expel air from the syringe.
6.
When finished filling the syringe from the prefilled syringe,
remove and discard the FFA and prefilled syringe.
5