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Idiomas disponibles
Idiomas disponibles
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 Cascade Transfer Set with dual check valve is a
sterile, single use disposable device for transferring contrast media
from three contrast bottles into a Front Load Syringe. This transfer set is
®
intended for use with MEDRAD
CT power injector applications. The
MEDRAD CT power injector and Front Load Syringe must be operated in
accordance with their instructions for use.
Contraindications: These devices are not intended for multiple patient-
use nor for any other use for which they are not indicated.
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
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.
Do not use with angiographic injectors or high pressure
applications greater than 300 PSI (20.7 bar). Pressures generated
by Angiographic injectors may result in damage to the dual check
valve, causing contrast spills which could cause personal injury and/
or equipment damage.
Do not use with flow rates higher than 4 milliliters per second,
or pressures above 170 PSI (11.7 bar). Pressures generated by
faster flow rates may result in damage to the dual check valve. A
damaged dual check valve may cease to function as intended, or
could leak. Leaks and spills of contrast media could cause hazards
resulting in personal injury and/or equipment damage.
Do not connect a patient to the injector until all trapped air has
been cleared from the syringe and fluid paths. Air embolization
can cause patient injury or death. Operator vigilance and care,
coupled with an appropriate procedure is essential to the avoidance
of air embolism. Refer to the Injector's Operator Manual and syringe
"Instructions for Use" for additional information regarding loading
®
procedures and use MEDRAD
Fluidot indicators.
Ensure fluid path is open before injecting. Failure to do so may
cause damage to the dual check valve, resulting in spills which could
cause personal injury and/or equipment damage.
Spikes must be connected to contrast bottles in the sequence
indicated in Step 1. Failure to do so may result in contrast spills
which could cause personal injury and/or equipment damage.
WARNING
All spikes must be connected to contrast bottles before use.
Failure to do so may result in contrast spills which could cause
personal injury and/or equipment damage.
Operator injury could result from using a sharp spike. Use care
in handling and inserting the spike into the bottle.
Use aseptic technique in product handling and making connections
to avoid contamination.
The PVC tubing in this product contains DEHP, a chemical known to
the State of California to cause birth defects or other reproductive
harm.
Extremely high doses of phthalates such as DEHP have been
reported to cause birth defects in research animals. Although
limited scientific data is available on the effect of phthalates in
humans, health authorities recommend that exposure to devices
containing these compounds be minimized as much as possible for
children and nursing or pregnant women.
DEHP is also a substance on the candidate list of Substances of Very High
Concern (SVHC) according to Article 59 of REGULATION (EC) no. 1907/
2006 concerning the Registration, Evaluation, Authorization and
Restriction of Chemicals (REACH).
Substance Name
CAS Number
Bis (2-ethyl(hexyl)phthalate)
117-81-7
(DEHP)
CAUTION
Transfer set connections must be hand tight to avoid damage to the
syringe and the transfer set. Use 1/4 to 1/2 turns when connecting
the Cascade Transfer Set to Front Load Syringes for MEDRAD CT
injectors.
Avoid or remove kinks in the tubing by adjusting the placement of
the spikes. Kinked tubing will reduce the filling rate performance of
the Cascade Transfer Set.
PROCEDURE FOR USE
Figure 1
3
•
Inspect the transfer set and package for damage. Do not use if
the package is opened or damaged.
•
Use aseptic technique.
•
The syringe must be attached to the injector and pointed
upward. The piston and syringe plunger must be in a full
forward position when filling the power injector syringe.
•
Use slow filling rates to reduce formation of bubbles when
filling the power injector syringe.
Step 1. Connect Transfer Set to the Contrast Bottles (see Warnings
and Cautions).
a. Prepare the contrast bottles for spiking.
b. Remove the protective cover from spike #1,
(see Figure 1), and insert it into a contrast bottle.
c. Remove the protective cover from spike #2,
(see Figure 1), and insert it into a contrast bottle.
d. Remove the protective cover from spike #3,
(see Figure 1), and insert it into a contrast bottle.
Step 2. Connect Transfer Set to Front Load Syringe for CT (see
Cautions).
a. Remove the orange protective cap from the female luer of
the transfer set.
b. Remove the protective cap from the Front Load Syringe.
c. Connect the transfer set to the Front Load Syringe using
hand-tight connections.
Ec Number
Dual Check Valve Operation
204-211-0
•
When connected to the syringe, retracting the plunger draws
the contents from the spiked contrast bottles into the syringe.
•
When connected to the syringe, advancing the plunger forces
the contents of the syringe through the male luer of the dual
check valve.
NOTE:
The dual check valve may make a squealing sound
during operation, particularly when drawing or pushing air.
This is considered normal.
Cascade Transfer Set Operation
•
When connected to the Cascade Transfer Set, the three contrast
bottles behave as a single reservoir of contrast media.
•
As contrast media is drawn through the dual check valve during
syringe filling, the contrast bottles empty in a cascading
manner.
•
The contrast bottles are automatically emptied in succession
from bottle 3 into bottle 2, and from bottle 2 into bottle 1 (see
Figure 1). In this way, bottle 3 will empty first, bottle 2 will
empty second, and bottle 1 will empty last.
NOTE:
Flow rates may vary between the contrast bottles
and the dual check valve. Flows between bottles in the three-
bottle reservoir may continue after syringe filling is completed.
These flows will end when pressure within the reservoir system
equalizes. This is considered normal.
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