Bayer medrad Twist & Go TAG C50 HPCT Mode D'emploi page 7

Introduction: Read the information contained in these
instructions for use. Understanding the information will assist you
®
in using the MEDRAD Twist & Go (Twist & Go) High Pressure
Connector Tubing properly.
Important Safety Notice: The Twist & Go High Pressure
Connector Tubing is intended to be used by qualified medical
professionals with proper training and experience in angiographic
procedures and the use of injectors from Bayer.
As with any injector, operator vigilance is required when using an
Injection System. Visual inspections and good practice during set-
up and use and compliance with the operation manual remain the
primary methods to limit the risk of air being present during fluid
delivery.
Indications for Use: The Twist & Go High Pressure Connector
Tubing is intended to be used in the delivery of contrast media and
common flushing solutions. The device is indicated for single use
only with injectors from Bayer with Twist & Go Syringes.
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).
WARNING
Air Embolism Hazard. Serious patient injury or death
may result.
• Ensure that one operator is designated as being
responsible for purging the High Pressure Connector
Tubing. 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 High Pressure Connector Tubing.
• Remove all air from the High Pressure Connector
Tubing.
• Use caution when removing air from the syringe or
tubing connections. Component damage may result
from the use of tools during air removal.
• Securely tighten the high pressure connector tubing to
syringe tip connection. Component damage may result
from the use of tools during tightening.
• Do not use tubing to manipulate the injector position.
• Avoid contact of and damage to syringe tip, tubing and
connections when manipulating injector position.
WARNING
Bloodborne Contamination Hazard. Serious patient
and/or worker injury or death may result.
• Use caution when removing air from the syringe or
tubing connections. Component damage may result
from the use of tools during air removal.
• Do not use tools to securely tighten the high pressure
connector tubing to syringe tip connection.
• Avoid contact of and damage to syringe tip, tubing and
connections when manipulating injector position.
• 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 exceed 1200 psi (8273 kPa).
• Do not use tubing to manipulate injector position.
Biological Contamination Hazard. Serious patient and/
or worker injury or death may result.
• Properly discard disposables after use if contamination
may have occurred during setup or use.
CAUTION
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 high pressure
connector tubing.
7
INSTALLING, FILLING AND PURGING A HIGH PRESSURE
CONNECTOR TUBING
1. Remove the dust cap from the syringe tip if attached.
2. Insert the Twist & Go High Pressure Connector Tubing onto
the Twist & Go syringe tip.
3. Turn the Twist & Go (A) nut
clockwise to securely tighten the
high pressure connector tubing to
the syringe tip (B).
4. Purge all air from the high pressure
connector tubing. Use the injector
to push contrast and flushing
solutions out until all of the air has
been removed from the High
Pressure Connector Tubing. Gentle
tapping at any connection point
may be needed to facilitate air removal.
A
B