Bayer Medrad Avanta AVA 500 HC Mode D'emploi page 7

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Introduction: Read the information contained in this brochure.
Understanding the information will assist you in using the MEDRAD
Avanta Sterile Hand Controller properly.
Important Safety Notice: The MEDRAD Avanta Sterile Hand
Controller is intended to be used by medical professionals with
adequate training and experience in the operation of the MEDRAD
Avanta Fluid Management Injection System and angiographic
procedures and techniques.
Indications for Use: The MEDRAD Avanta Sterile Hand Controller is
specifically intended for use with the MEDRAD Avanta Fluid
Management Injection System in the x-ray angiography environment.
Contraindications: The MEDRAD Avanta Sterile Hand Controller is
only intended to be used with MEDRAD Avanta Fluid Management
Injection System.
Restricted Sale: Rx Only.
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).
Warnings
• Air embolization can cause death or serious injury to the
patient. Do not connect a patient to the injector, or attempt an
injection until all trapped air has been cleared from the syringe
and fluid path. Carefully read the instructions of the use of
FluiDots indicators (where applicable) to reduce the chance of
air embolism.
• Biological contamination can result from reusing
disposable items or failure to follow sterile technique.
Properly discard disposable items after use. If there is any
possibility that contamination may have occurred during
set-up or use, disassemble and set-up a new sterile product.
NOTE: If the MEDRAD Avanta Sterile Hand Controller is used without
the optional MEDRAD Avanta Hand Controller Sterile Sheath, discard
the hand controller after each patient.
• 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.
• Patient or operator injury may result from contrast media
leaks or ruptures to the syringe or connector tubing.
Use of greater pressure or occlusions in the fluid path may
result in leaks or ruptures to the syringe or connector tubing.
Ensure that the fluid path is open; do not exceed appropriate
pressure.
Caution
• Component damage may occur if not installed properly.
Assure all connections are secure; do not overtighten. This
will help minimize leaks, disconnections, and component
damage.
NOTE: Refer to the injector operation manual and the MEDRAD
Avanta Hand Controller Sterile Sheath IFU for additional information.
Hand Controller Installation
The MEDRAD Avanta Sterile Hand Controller can be used for up
to five patients. Sterility can be maintained between patients by
using MEDRAD Avanta Sterile Hand Controller Sheaths (available
for purchase).
1. Ensure that the injector is in the disarmed state.
2. Open the hand controller bag using sterile technique.
3. Using sterile technique, remove the hand controller from the bag.
4. Plug the hand controller into the Fluid Control Module – Hand
Controller Connector (see drawing below). Listen for an audible
"click" to confirm proper connection.
NOTE: If the hand controller is damaged or does not work properly,
discontinue use and discard.
Fluid Control Module
MEDRAD Avanta
Sterile Hand Controller
Hand Controller
Connector
5. Follow instructions provided in the MEDRAD Avanta Fluid
Management Injection System Operations manual for hand
controller use.
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