Lantheus Medical Imaging VIALMIX RFID Operating instructions

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VIALMIX . /110
Activation Device for DEFINITY ® Vial for (Perflutren
Lipid Microsphere) Injectable Suspension
User's Guide/
Instructions for Use
\~ Lantheus
'W' Medical Imaging·
51 6041- 111 8

Table of Contents
Safety Precautions 3
Meaning of Safety Symbols 4
System Overview 5
Setup 6
Operation 6
Usage Counter 9
Error Messages 9
Troubleshooting 13
Maintenance 13
Cleaning 13
VIALMIX®RFID Calibration and Replacement Procedures 14
Electrical Safety and Electromagnetic Compatibility (EMC) 14
Specifications 17
Contact Information 18
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SAFETY PRECAUTIONS
IMPORTANT: Read this section carefully before plugging in and operating the unit. VIALMIX®RFID must
be used in strict accordance with these instructions. Lantheus Medical Imaging has no liability for any
damage arising from any other use of this unit.
WARNING: Do not operate VIALMIX®RFID and RFID-tagged vials within 6 inches (15cm) of a pacemaker
and/or defibrillator or any other implantable or body worn devices such as neurostimulators and insulin
pumps.
WARNING: Use of VIALMIX®RFID adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this equipment and the other equipment should
be observed to verify that both are operating normally. If any abnormalities in VIALMIX®RFID operation are
observed (i.e. display screen distortion, unusual or unexpected noises, incomplete countdown, or power
disruption) DO NOT use the DEFINITY® vial being activated as the vial may not have been properly activated.
Retain the vial and call Lantheus Medical Imaging (see page 18).
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the VIALMIX®RFID, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could
result. If any degradation of VIALMIX®RFID performance is observed (i.e. display screen distortion or power
disruption) DO NOT use the DEFINITY® vial being activated. Vial may not have been properly activated.
Retain the vial and call Lantheus Medical Imaging (see page 18). Remove any possible source of RF emissions
from area of operation of VIALMIX®RFID before attempting to activate another DEFINITY® vial. If the issue
continues, please contact Lantheus Medical Imaging (see page 18).
•VIALMIX®RFID must only be operated with the lid closed and intact.
•Do not store vials under the lid. Only the DEFINITY® vial placed in the cradle intended for immediate activation
should be in the enclosure.
•VIALMIX®RFID must be placed on a level surface and away from the edge of the surface.
•A dangerous condition can result from condensation build-up. Before using VIALMIX®RFID, allow the unit to
reach room temperature, particularly when moving it from a colder to a warmer environment.
•To safely operate VIALMIX®RFID, insert the main plug only into an appropriate outlet with a grounded conductor.
VIALMIX®RFID can operate using 120 to 240 volts, 50 to 60 Hz power. If an extension cord is used, make sure that
the ground conductor is not broken.
•In order to avoid electrical shock, DO NOT INSERT ANY OBJECTS INTO THE UNIT.
•If, for any reason, it is possible that the safety of VIALMIX®RFID has been compromised, that unit must be
removed from operation and identified in such a way that it is not inadvertently operated again. For example, do
not attempt to use VIALMIX®RFID if it does not work as specified or is visibly damaged.
•Keep solvents, inflammable liquids, and heat sources away from unit.
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•Do not allow cleansers to get into unit during cleaning; an electrical short or a dangerous malfunction may
occur. Do not immerse unit in any liquid.
•If the unit is not operating as expected, please contact Lantheus Medical Imaging (see page 18). Do not open
unit housing or attempt to perform any maintenance or repair.
•VIALMIX®RFID must be properly disposed of at the end of its service life. To dispose of VIALMIX®RFID, contact
Lantheus Medical Imaging (see page 18).
MEANING OF SAFETY SYMBOLS
SYMBOL
MEANING
Signifies that the instruction/manual booklet must be
read
Signifies a mandatory action
Alerts the user to important information and/or warnings
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SYSTEM FEATURES OVERVIEW
VIALMIX®RFID is the activation unit designed specifically for DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable
Suspension, an intravenous ultrasound contrast agent. DEFINITY® is supplied as a liquid-filled glass vial and requires
activation in order to create the lipid-encapsulated microbubbles. The activation rate and duration are controlled by
VIALMIX®RFID through the use of Radio-Frequency Identification (RFID) technology to ensure reproducible activation of
DEFINITY®.
FEATURES OF VIALMIX®RFID INCLUDE:
Proper Activation of DEFINITY®
A number of digital messages inform the user of an unsuccessful activation. In the event the activation cycle
stopped short of the required activation time or the activation rate deviated from the acceptable range, the user
is alerted via digital messages on the display and an audible alarm. See page 9 for a list of error messages.
IMPORTANT: Shaking the DEFINITY® vial by hand will not activate the agent properly.Using
VIALMIX®RFID to activate DEFINITY® will ensure proper activation of the agent and consistent product
performance. DO NOT use a DEFINITY® vial if it is not properly activated in VIALMIX®RFID
Simple Operation
VIALMIX®RFID has two operational buttons on the front panel.
1. A START button for starting the activation cycle
2. A STOP button for canceling the activation cycle if needed
VIALMIX®RFID allows for easy loading of the DEFINITY® vial into the vial carrier.
VIALMIX® RFID is equipped with an RFID reader.Once the DEFINITY® vial is loaded in the vial carrier and the
cover is closed, the VIALMIX®RFID will read the RFID tag embedded in the DEFINITY® vial label and will
automatically set the required activation rate and activation time. The appropriate activation time of 45
seconds will appear on the display. The addition of RFID capability to the VIALMIX®RFID is completely transparent
to the user and does not require any additional actions to activate DEFINITY®.
Safe operation
VIALMIX®RFID contains features that ensure safe operation. These include:
An automatic shut-off switch that is activated if the cover is opened during operation.
A STOP button to allow the user to terminate the activation cycle.
A thermal sensor shut-off to prevent overheating.
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