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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. These devices are
indicated for single-use only with injectors
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).
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 on-
ly. Re-use of the single use disposable de-
vices pose risks of device failure and risks to
the patient. Potential device failure includes
significant component deterioration with ex-
tended 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 validat-
ed to be cleaned or re-sterilized.
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 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.
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 to store contrast
media. Use loaded syringes immediately.
Do not store loaded syringes for later use.
Discard unused loaded syringes.
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 tubing
ruptures. Ensure that the fluid path is open;
do not exceed pressures identified on the
front of the package. Use of greater
pressures or occlusions in the fluid path
may result in leaks or ruptures to the
connector tube.
Cautions
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.
Refer to the Injector Operation Manual
for further instructions.
MEDRAD Mark IV, MEDRAD Mark V,
MEDRAD Mark V Plus, MEDRAD Mark V
Provis, or MEDRAD CT-100/200/300
Series Injectors:
1. Ensure that the piston on the head is fully
retracted. To retract the piston(s), press
the Reverse Load Switch on the injector
head.
2. Set the Mechanical (safety) Stop to zero in
the full forward position (applies to
MEDRAD Mark IV and MEDRAD CT-100
Series Injectors only). Position the empty
Pressure Jacket in the top of the turret. If
there is a syringe in the top pressure
jacket, remove and discard.
3. Remove the syringe from its package and
slide it in the top Pressure Jacket (the flat
side of the flange must face upward). This
positions the nut with its cutout facing up
for easier hub attachment.
4. Fully rotate the turret to place the syringe
plunger in front of the piston.
Note: The turret must be fully rotated to the
closed position to ensure piston/syringe
plunger alignment to prevent contrast
leakage.
The following are general guidelines only.
For additional instructions, refer to the
Operation Manual for your Liebel
Flarsheim injector.
Liebel Flarsheim 6000 and 6000 CT
Injectors:
1. Ensure that the piston on the head is fully
retracted.
2. Unlock pressure jacket and rotate
downward.
3. Remove syringe from its package and
insert syringe into pressure jacket, making
sure to position alignment key with
pressure jacket slot.
4. Rotate pressure jacket plate upward and
latch by turning knob fully clockwise.
5. Advance piston to engage syringe plunger.
Liebel Flarsheim Angiomat Injector:
1. Press the LOAD button on the console.
Press the LOAD button on the head to fully
retract the plunger.
2. Set the mechanical stop at zero.
3. Open the turret door so the pressure jacket
is ready to accept a syringe. If there is a
syringe in the pressure jacket, remove and
discard.
4. Remove syringe from its package and
insert syringe into pressure jacket.
5. Close and secure the turret.
6. Press the UNLOAD button to advance the
piston forward.
Syringe Filling:
Note: One person should fill and arm the
injector. If you must change the injector
operator, be certain that the second operator
verifies that the syringe is properly filled and
that any air is eliminated.
1. Tilt the injector head up.
2. Press and hold the forward motion control
until the piston is fully advanced.
3. Remove the protective covers from the
syringe luer tip and attach a sterile filling
device onto the tip of the syringe (Quick Fill
Tube or other filling device).
4. Transfer the contrast media into the
syringe using a Quick Fill Tube. Raise the
contrast bottle until the Quick Fill Tube is
fully inserted. The end of the Quick Fill
Tube should be near the bottom of the
contrast bottle.
Note: Use a Quick Fill Tube or equivalent
device to reduce the volume and size of air
bubbles drawn into the syringe during
filling. It is more difficult to remove the air
bubbles if you use smaller diameter tubes,
such as a catheter-over-needle, or a tube
longer than 10 in. (25cm.)
5. Aspirate contrast media into the syringe.
6. Press and hold the REVERSE piston
motion key until the syringe is filled with the
volume of contrast media desired.
7. Use the FluiDots indicators to help you
detect the presence of contrast media in
the syringe. Verify that the FluiDots
indicators are round in the filled portion of
the syringe. The rounded shape of the
FluiDots indicators varies according to the
type of contrast media, but an oblong
shape indicates the presence of air.
Rounded FluiDots indicators do not
indicate the total absence of air bubbles in
the syringe tip
Expelling Air and Attaching the Connector
Tube:
After you fill the syringe, you must expel all air
from the syringe and then attach the
connector tubing. To do so:
1. Remove the filling device and expel air
from the syringe by manually advancing
the piston so that the contrast media is in
the tip of the syringe.
Gently tap the base of the pressure jacket
to dislodge the air bubbles. Expel
remaining air.
2. Attach the connector tube to the syringe:
a. FasTurn - Place the connector tube
hub in the syringe nut's cutout. Turn
the syringe nut clockwise approxi-
mately 2 1/4 turns until secure while
holding the hub stationary.
b. Push-N-Turn - Place the connector
tube hub in the syringe nut's cutout.
Push the syringe nut towards the in-
jector head until it snaps; turn the nut
clockwise approximately 1 turn until
secure.
NOTE: Position the hubs so that when the
syringe nut is secure, the wings are across
the cutout, not with one wing in the cutout.
3. Verify that the tubing is not kinked or
obstructed.
4. Use the manual knob to advance the
syringe plunger to provide a slow flow of
contrast media through the connector
tubing.
An absence of flow is an obvious indication
of air in the fluid path
5. Prime the connector tubing and make
certain that the air is expelled.
6. Verify that all of the air has been expelled
from the syringe and fluid path.
7. Attach the connector tube to the vascular
entry device.
8. Tilt the injector head down.
Removing a Syringe:
To remove the syringe when the procedure
has been completed, fully retract the piston
and rotate the turret counter-clockwise.
Remove the syringe from the pressure jacket.
Discard all used components.
7
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