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MEDRAD® MRXperion Instructions For Use | Mode d'emploi
ENGLISH
Introduction: Read the information contained in this
section. Understanding the information will assist you 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 or
saline. They are indicated for single use on one patient only
with MEDRAD® MRXperion MR Injectors.
Contraindications: None known.
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
Re-using fluid containers for more than one
procedure may result in biological contamination.
Discard contrast and saline containers after filling
syringes for a single procedure.
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.
Reuse of this product may result in biological
contamination, product degradation and/or product
performance issues. Properly discard disposable items
after single use, or if there is any possibility that
contamination may have occurred.
Syringe sterility will be compromised, and patient
infection may result, if the plunger is removed from
the syringe. Do not remove the plunger to fill the
syringe.
Bacterial contamination can occur if syringes are
used as storage containers. Use loaded syringes
immediately. Do not use syringes to store fluids for
later use. Discard unused loaded syringes.
Warnings
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.
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 fluid
leaks or syringe or tubing ruptures. Ensure that the
fluid path is open and do not use syringes and tubing
rated below 350psi (2410 kPA). An occlusion in the fluid
path and/or use of syringes or tubing rated below
350psi (2410 kPA) may result in leaks or ruptures.
Patient injury could result if syringe is not properly
engaged. Do not load or inject unless the syringe is
properly engaged.
Use care in handling and inserting spike into the
fluid source. The spike is sharp and may cause
personal injury.
Contamination may occur if the end of the spike or
luer connector are touched. Do not touch the end of
the spike or luer connector.
Cautions
Component damage or leaks may occur if not
installed properly. Ensure all connections are secure;
do not over-tighten. This will help minimize leaks,
disconnection, and component damage.
Refer to the Injector Operation Manual for further
instructions.
Installing New Syringes
NOTE:
Use good clinical practice during the loading
process to maintain sterility of the syringe kit
when opening.
NOTE:
Disposable shall be used by use by date as
shown on each package.
1.
Remove the syringes from packaging.
2.
Insert the syringes by pushing them down into the
receptacle until they are securely in place (an
audible click is heard).
3.
Remove the dust covers from the tip of each syringe.
4.
Ensure that the plungers are fully advanced.
Figure 1 - 1: Installed Syringes
Filling the Syringes
The syringes on the MRXperion injector can be filled
automatically or manually.
NOTE:
Use the small syringe (65mL) and small spike
to load contrast media into Syringe A. Use the
large syringe (115mL) and large spike to load
saline into Syringe B.
Filling the Syringes: Automatic
NOTE:
During filling, point the injector head up.
During an injection, point the injector head
down.
NOTE:
Auto Fill of Syringe A and Syringe B cannot be
started simultaneously.
1.
Set and lock protocol with the desired volumes.
2.
Install new syringes.
3.
Remove the small spike from the packaging. Remove
the dust cover from the luer end of the spike. Install
the small spike onto the contrast syringe (Syringe A).
Do not install with excessive force. Remove the cover
from the tip of the spike. Insert the spike into the
fluid source.
4.
Press the Fill A button twice to begin
Auto Fill of Syringe A.
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