Bayer Medrad Twist & Go Gebrauchsanleitung Seite 7

Introduction: Read the information contained in these
instructions for use. Understanding the information will assist you
Twist & Go
in using the MEDRAD syringe properly.
Important Safety Notice: The MEDRAD
intended to be used by qualified medical professionals with proper
training and experience in angiographic procedures and the use
®
of the MEDRAD Mark 7 Arterion Injection System
operations manual is intended as instructions on the proper use of
the MEDRAD Mark 7 Arterion injector and syringe.
As with any injector, operator vigilance is required when using the
MEDRAD Mark 7 Arterion injector/syringe. Visual inspections and
good practice during set-up and use and compliance with the
operator's manual remain the primary methods to limit the risk of
air being present during fluid delivery.
Indications for Use: The MEDRAD Twist & Go
Tube and other disposables supplied from Bayer are specifically
intended for single use only with the MEDRAD
Injection System
for angiographic studies.
Contraindications: This device is not intended to be used for
chemotherapy and is 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)..
WARNING
Air Embolism Hazard. Serious patient injury or death
may result.
• Ensure that one operator is designated as being
responsible for filling and refilling the syringe. Do not
change operators during the procedure. If an operator
change must occur, ensure that the new operator
verifies that the fluid path is purged of air.
• Ensure that patient is not connected while purging air
from syringe, or engaging or advancing plunger.
• Orient the Injector Head to the Purge (upright) position
during filling of syringe and purging of air.
• Purge all air out of syringe and any and all disposables
after filling.
• Tap syringe after filling to facilitate air removal.
®
• Verify that the MEDRAD FluiDots indicators are
rounded to ensure that fluid is present in the syringe.
Bloodborne Contamination Hazard. Serious patient
and/or worker injury or death may result.
Twist & Go
syringe is
• Use caution when removing air from the syringe.
Component damage may result from the use of tools
during air removal.
. The
• Press the End Case button on the Display Control
Unit. Select Yes to acknowledge that you want to end
the case, and that the patient has been disconnected
from the system.
• Alternatively, turn the Manual Knob counter-
clockwise to retract the syringe plunger 2ml.
• Do not exceed 1200 psi (8273 kPa)
Biological Contamination Hazard. Serious patient and/
Syringe, Quick Fill
or worker injury or death may result.
• Properly discard disposables after use or if
Mark 7 Arterion
contamination may have occurred during setup or use.
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.
Environmental Contamination Hazard. Patient and/or
worker injury may result.
• 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.
• Follow sterile technique principles, specifically,
maintain sterility of the syringe tip and plunger and
syringe barrel internal surface, and Quick Fill Tube.
• Do not scrape off dried, potentially contaminated
contrast into recesses during syringe installation.
• Do not reuse disposables.
Bacterial Contamination Hazard. Patient and/or worker
injury may result.
• Use filled syringes immediately.
• Do not store filled syringes for later use.
• Discard previously filled unused syringes.
WARNING
CAUTION
7
INSTALLING A SYRINGE
Prior to installing a syringe, ensure that the system is on and the
pressure jacket is installed.
1. Ensure the syringe piston is fully retracted. To retract the
piston, press the Enable button (A), and then press
reverse arrows (B) on the Fill Strip (C).
F
D
E
C
J
NOTE: Your finger placement on the Fill Strip
determines the speed at which the syringe retracts or
advances. Move your finger away from the Enable button
to increase the speed.
2. Open the syringe package and remove the syringe.
3. Insert the syringe in the Pressure Jacket. Install the
syringe with the raised syringe alignment key (D) aligned
with the triangle (E) on the Pressure Jacket.
4. Maintain syringe tip sterility, and raise and completely
close the drop front (F).
5. On the Injector Head, press the Enable button, and then
press the forward arrows (G) on the Fill Strip to fully
advance the plunger in the syringe.
See Next Page for Filling, Purging, and Removing Syringe
I
A
G
B