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Introduction: Read the information contained in this brochure.
Understanding the information will assist you in using the sterile
Disposable Sets properly.
Important Safety Notice: The MEDRAD® Avanta Sterile Disposable
Sets are 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 Disposable Sets
are specifically intended for use in the x-ray angiography environment.
They are designed to administer intravascular radio-opaque contrast
compounds, and common flushing agents at various volumes and flow
rates into humans for use in diagnostic and interventional angiographic
procedures performed in cardiology, radiology, and vascular surgery.
Contraindications: For use only with the MEDRAD® Avanta Fluid
Management Injection System. The MEDRAD® Avanta Sterile
Disposable Sets are not intended to be used for chemotherapy and are
not intended to administer fluids other than intravascular contrast agents
and common flushing solutions.
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
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.
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 air has been removed from the syringe and fluid
path. Carefully read the instructions for loading and the use of
MEDRAD® FluiDots indicators (where applicable) to verify that
fluid is present and to reduce the chance of air embolization during
an injection.
Do not attempt to aspirate fluid from the waste port stopcock
when open to the PIV. Doing so may increase the risk of inducing
air into the fluid path.
Do not attempt to aspirate fluid from the hemodynamic port.
Doing so may increase the risk of inducing air into the fluid path.
Before connecting the Single-Patient Sterile Disposable Set
(SPAT) to the patient, ensure all stopcocks and open ports are
closed to air and all air has been removed from the fluid path
before injection. Improper manipulation of the waste port
stopcock as well as any fluid port left open to air may increase the
risk of introducing air into the fluid path.
Biological contamination can result from reusing disposable
items or failure to follow sterile technique during setup or use.
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.
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 mishandling of the
sharp spike. Use care in handling and inserting the spike into the
contrast bottle and the saline bag/bottle.
Storage of filled syringes can promote bacterial growth.
Syringes from Bayer are designed to be filled just prior to the
procedure. Discard unused filled syringes.
Patient injury could result if syringe is not properly engaged.
Improper engagement may cause air embolization or under-
volume delivery.
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.
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.
Inadvertent aspiration can occur if the Multi-Patient
disposable contrast tubing set is kinked or blocked during a
syringe fill process. Verify multi-patient contrast tubing is free of
kinks before attempting to fill the syringe.
Patient injury can result if the patient is connected during any
contrast or saline purge. Ensure the patient is disconnected
before any purge.
Blood can contaminate the multi-patient portion of the
disposable set. Ensure that blood does not appear past the
pressure isolation valve in the single patient disposable set.
Ensure vent cap on spike(s) are open if using bottles. If closed,
a vacuum may be created and air may be introduced.
Do not exceed the five patients per day usage requirement for
the Multi-patient Disposable Set (MPAT). This is the usage
approved by appropriate regulatory bodies.
Use of non-Bayer supplied disposables, including
administration sets and additions to administration sets, such
as but not limited to bleed back control devices and pressure
transducers may cause patient injury if not properly
connected or flushed. These devices must be compatible with
your system. Refer to manufacturer's instructions for proper use
of these devices.
Use of extension tubing connected to the Single Patient
Disposable Set may cause patient injury and will degrade
system performance. Do not connect extension tubing to the
Single Patient Disposable Set.
Cautions
Component damage may occur if disposables are not installed
properly. Assure all connections are secure. This will help minimize
leaks, disconnections, air introduction, and component damage.
Do not use tools to over tighten connections or to assist in removal
of disposables.
Do not use methyl alcohol on disposable sets. Use of methyl
alcohol will degrade the integrity of the disposable sets.
All contrast and saline media should be used in accordance
with the manufacturer's indication for use.
NOTE: To perform the following procedures, the operator must
select the Case Setup screens on the DCU. Refer to the injector
operation manual for additional information.
Multi-Patient Sterile Disposable Set (MPAT) Installation (usable for
up to five patients). The Multi-Patient Disposables Set consists of the
following items. (Also see MPAT Setup illustration):
Vented Contrast Spike
2nd HPCT w/ male luer
Contrast Drip Chamber
Saline Spike
Low Pressure Contrast Tube (LPCT)
Saline Drip Chamber
High Pressure Contrast Tube (HPCT)
Low Pressure Saline Tube (LPST)
Contrast Flow Control Valve (CFCV)
Post Drip Chamber Saline Tube
150 mL Multi-Patient Syringe
Drip Chambers
MPAT Setup
Saline Contrast
LPST
Venter Contrast
Spike
Saline Spike
Peg
2nd HPCT
General Setup Instructions
Be sure that the patient is disconnected and the injector is on.
1. Install syringe. (See Install Multi-Patient Syringe below).
2. Install saline tubing (See Install Saline Tubing below).
3. Install contrast tubing. (See Install Contrast Tubing below).
4. Rotate head to upright position, fill syringe and remove dust caps.
5. Purge multi-patient disposables. Catch the discharged fluid in a
suitable container and tap disposable connection points and
pressure jacket to remove air.
6. Rotate head downward.
7. Attach MEDRAD® Avanta Sterile Hand Controller, and maintain
sterility, if applicable.
NOTE: Refer to Operation Manual for MEDRAD® Avanta Fluid
Management Injection System for further information.
After step 7 in the General Setup Instructions is complete, go to SPAT
Installation.
Install Multi-Patient Syringe
NOTE: Ensure patient is not connected.
Select Multi-Patient Syringe from Case Setup.
1. Retract piston.
2. Insert syringe into pressure jacket and raise drop front arms.
3. Engage the piston to the plunger.
Install Saline Tubing
NOTE: Ensure patient is not connected.
Select Multi-Patient Disposables from Case Setup, then select Install
Saline Tubing.
1. Install drip chamber.
2. Route tubing through pump and close door.
3. Route tubing around peg.
4. Insert tubing into gross air detector and close door.
5. Spike saline bag.
6. Fill saline drip chamber completely and snap into position before
use.
NOTE: To differentiate the saline and contrast lines of the MPAT, the
contrast line will be identified as the line connected to the stopcock that is
placed in the CFCV.
Install Contrast Tubing
Select Install Contrast Tubing from Case Setup.
1. Install drip chamber.
6
2. Connect tubing to syringe.
3. Install stopcock.
4. Insert tubing into gross air detector and close door.
5. Spike contrast bottle.
6. Fill contrast drip chamber completely and snap into position before
use.
Go to step 4 in General Setup Instructions.
Single-Patient Sterile Disposable Set (SPAT) Installation (must be
replaced for each patient use). The Single-Patient Disposable Set
consists of the following items (Also see SPAT Setup illustration):
Rotating luer (A)
LPCT
CFCV
Stopcock for waste port (B)
Pressure Isolation Valve (PIV) Assembly /
Hemodynamic pressure monitoring port (C)
Syringe
Single-Patient Sterile Disposable Set (AVA 500 SPAT Angio) is indicated
for use when a user attachable transducer is unnecessary and does not
contain item (C) pictured below.
HPCT
C
B
A
Select Single-Patient Disposables from Case Setup.
Be sure that the patient is disconnected.
1. Remove all dustcaps.
2. Connect the SPAT saline tube to MPAT saline tube.
3. Connect the SPAT contrast tube to MPAT contrast tube.
To purge air out of SPAT:
NOTE: Ensure patient is not connected.
When using AVA 500 SPAT L continue with step 4. When using AVA 500
SPAT ANGIO proceed to step 5.
4. Attach transducer to hemodynamic port, verify the transducer
stopcock is open, and the waste port stopcock is off to waste port.
a.
Attach 20cc saline syringe to the transducer port.
b.
Hold SPAT parallel to the patient with the PIV and 20cc
syringe connection facing upward at a 45° angle.
c.
Forcefully flush through the transducer and PIV assembly
until all air is expelled from both components. Flick or tap PIV
to facilitate air removal (Repeat as necessary).
d.
Close transducer port stopcock. Remove 20cc syringe.
5. Initiate contrast and saline purge, tap SPAT to MPAT saline
connection point and wasteport stopcock to remove air while
purging is in progress.
6. Repeat steps above as needed, until all air is purged.
7. Carefully inspect the entire SPAT and MPAT to verify all air is
removed before connecting to patient
NOTE: Disconnect the SPAT from the MPAT immediately following
each procedure.
High Pressure Saline Tube w/
male luer connector (D)
High Pressure Contrast Tube w/
female luer connector (E)
D
E
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