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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SET-UP
VIALMIX®RFID is packaged with a power cord and a Quick Reference Guide. Upon receipt of VIALMIX®RFID and prior to
use with DEFINITY®, the user must perform the following steps.
1. Remove VIALMIX®RFID and its power cord from the package.
2. Remove all packing materials from the unit.
3. Place VIALMIX®RFID on a flat surface.
4. Open the cover and remove the shipping restraint from the arm.
5. Connect VIALMIX®RFID to the main power source using the enclosed power cord.
OPERATION
Powering On VIALMIX®RFID
With VIALMIX®RFID properly connected to the main power supply, the unit can be powered on by moving the switch on
the back of the unit to the "I" position. Once powered on, VIALMIX®RFID will display the following when ready for use:
Loading the DEFINITY® Vial
With the cover open, the vial carrier is easily accessed for vial loading. The following screen will be displayed after the
cover is opened:
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Perform the following steps to load the DEFINITY® vial.
1. The vial carrier is spring loaded and opens to accommodate the DEFINITY® vial by means of the release lever.
Press the lever downward to unlatch the vial carrier then press the lever to the left to open the carrier for vial
loading.
2. Holding the DEFINITY® vial between your thumb and fingers, load the vial by placing the top of the vial in the left
cup of the carrier (see diagram below). The cups of the carrier are molded to best accommodate the vial when
the top of the vial is placed in the left cup. Either position (i.e. top of the vial in either cup) is possible and will
allow for acceptable activation of DEFINITY®.
IMPORTANT: To ensure cleanliness of the DEFINITY® vial septum, load the vial with the flip-top seal in
place.
3. Release the lever and the spring action of the carrier will hold the vial securely. Make sure that the vial is evenly
supported by both cups of the carrier.
4. Close the VIALMIX®RFID cover.
Activating the DEFINITY® Vial
With VIALMIX®RFID powered on, the vial in place, and the cover closed, the following will be displayed when the user is
ready to activate DEFINITY®.
The activation time of "45", representing 45 seconds, will appear on the VIALMIX®RFID display. If it does not display,
refer to the "Troubleshooting" section located on page 12.
Press the START button located under the display to begin the activation cycle. The cycle time on the VIALMIX®RFID
display will begin to count down to zero.
IMPORTANT: VIALMIX®RFID will not start the activation cycle with the cover in the open position. Do
not open the VIALMIX®RFID cover during the activation cycle. Doing so will render the vial unusable.
Acceptable activation is achieved only with an uninterrupted activation cycle.
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DEFINITY® is ready for use if VIALMIX®RFID shakes the vial uninterrupted for the full activation cycle with no error
messages displayed.The following screen will be displayed indicating a successful activation:
If the DEFINITY® vial does not shake for the full 45 second duration or at the acceptable rate, activation is not considered
successful and the vial must not be used. An error message will be displayed and an audible alarm will sound to alert
the user. Refer to page 9 for a list of error messages and the conditions they indicate.
If an interruption in power (power failure) occurs during an activation cycle, the activation is not considered
successful and the DEFINITY® vial must not be used. Once the power is restored, power cycle the unit using the
power switch located on the back of the unit. A new DEFINITY® vial is required for activation.
Removing the DEFINITY® Vial
After successful activation of DEFINITY®, the vial can be removed for use. To remove the vial, open the cover and follow
these steps:
1. Press the lever down to unlatch the vial carrier then press the lever to the left to fully open the carrier.
2. Remove the DEFINITY® vial from the carrier.
3. Release the lever and the spring action will close the carrier.
4. Close the cover.
Powering Off VIALMIX®RFID
VIALMIX®RFID should be powered off at the end of the day. This is done by moving the switch on the back of the unit to
the "O" position.
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USAGE COUNTER
VIALMIX®RFID is equipped with an internal usage counter which counts the total number of activation cycles performed.
A Usage Count Alert will be displayed on the VIALMIX®RFID main display (see page 11) when > 95% of the programmed
limit of activation cycles has been reached.Please contact Lantheus Medical Imaging Customer Service IMMEDIATELY
upon receiving this alert to request a new VIALMIX®RFID. Once the usage counter reaches 100% of the programmed
limit of activation cycles, a Usage Count Error message will be displayed on the VIALMIX®RFID main display (see page
11) and VIALMIX®RFID will cease to operate.
ERROR MESSAGES
In order to ensure acceptable activation of DEFINITY®,VIALMIX®RFID is programmed to display error messages that alert
the user in the event that the activation cycle is outside the required duration or rate. The table below shows a
complete list of error
messages, the associated VIALMIX®RFID response, the likely cause(s) of the error, and the action
required of the user.
Error
Associated VIALMIX®RFID Response
Likely Cause of
Message
Action Required by User
High Oscillation
Rate Error
High Oscillation Rate error message on
main screen (HE)
Audible alert
DEFINITY® vial has
shaken at higher
than acceptable
shake rate.
Do not use the DEFINITY®
vial. Vial was not properly
activated. Retain the vial and
call Lantheus Medical Imaging
(see page 18).
Press the STOP button to
clear the error.
Low Oscillation
Rate Error
Low Oscillation Rate error message on main
screen (LE)
Audible alert
DEFINITY® vial has
shaken at lower
than acceptable
shake rate.
Do not use the DEFINITY®
vial. Vial was not properly
activated. Retain the vial and
call Lantheus Medical Imaging
(see page 18).
Press the STOP button to
clear the error.
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Error
Associated VIALMIX®RFID Response
Likely Cause of
Message
Action Required by User
Motor Overcurrent Motor Overcurrent error message on main
screen (MC)
Audible alert
Excess mechanical
loading or motor
failure.
Do not use the DEFINITY®
vial. Vial was not properly
activated. Retain the vial and
call Lantheus Medical Imaging
(see page 18).
Power cycle the unit using the
power switch on the back of
the unit to clear the error.
Thermal Fault Thermal Fault error message on main
screen (OH)
Audible alert
Unit is overheating.
Do not use the DEFINITY®
vial. Vial was not properly
activated. Retain the vial and
call Lantheus Medical Imaging
(see page 18).
Power the unit off and allow
to cool. Once cooled, power
the unit on using the power
switch on the back of the unit.
Motor Overvoltage Motor Overvoltage error message on main
screen (MO)
Audible alert
Motor is operating
higher than standard
voltage condition
indicating potential
future failure.
Do not use the DEFINITY®
vial. Vial was not properly
activated. Retain the vial and
call Lantheus Medical Imaging
(see page 18).
Power cycle the unit using the
power switch on the back of
the unit to clear the error.
Motor Under
voltage
Motor Under voltage error message on main
screen (MU)
Audible alert
Motor is operating
lower than standard
voltage condition
indicating potential
future failure.
Do not use the DEFINITY®
vial. Vial was not properly
activated. Retain the vial and
call Lantheus Medical Imaging
(see page 18).
Power cycle the unit using the
power switch on the back of
the unit to clear the error.
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Error
Associated VIALMIX®RFID Response
Likely Cause of
Message
Action Required by User
RFID Read Error RFID Read error message on main screen
(RE)
Audible alert
1. RFID Tag does
not have
correct string
of data.
2. RFID Tag is
unreadable.
3. No DEFINITY®
vial in the
cradle.
Re-position the DEFINITY® vial
in the carrier. If the error re-
occurs, remove the vial and
place a new DEFINITY® vial in
the carrier.
Do not use the DEFINITY®
vial. Retain the vial and call
Lantheus Medical Imaging
(see page 18).
Cover Open (before
start button
pressed or pressed
and doesn’t work)
Cover open icon displayed Cover not closed
prior to start of
activation cycle.
Close the cover and press the
START button
Interrupted Cycle –
STOP button
pushed
Interrupted Cycle error message on main
screen (IC) Audible alert
User pushed STOP
button mid-
cycle, creates
partially activated
vial.
Do not use the DEFINITY®
vial. Vial was not properly
activated.
The error will clear once the
cover is opened, a new
DEFINITY® vial is placed in the
carrier, and the cover is
closed.
Interrupted Cycle –
Cover opened
Interrupted Cycle error message on main
screen (IC) with cover open icon
Audible alert
User lifted cover
mid-cycle, creates
partially activated
vial.
Do not use the DEFINITY®
vial. Vial was not properly
activated.
Press the STOP button to
clear the error
Place a new DEFINITY® vial in
the carrier and initiate
activation cycle by pressing
the START button.
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Error
Associated VIALMIX®RFID Response
Likely Cause of
Message
Action Required by User
Usage Count Alert Usage Count Alert message on main screen
(>95%)
VIALMIX®RFID has
exceeded 95% but
less than 100% of
the programmed
limit of activation
cycles.
Contact Customer Service
immediately for a
replacement VIALMIX®RFID
(see page 18).
VIALMIX®RFID will cease to
operate once 100% of
programmed limit of
activation cycles has been
reached.
Usage Count Error Usage Count error message on main screen
(100%)
VIALMIX®RFID has
reached the
programmed limit
of activation cycles
and is no longer
operational.
VIALMIX®
RFID
is no longer
operational. Call Customer
Service for a replacement
VIALMIX®RFID (see page
18). VIALMIX®RFID must be
properly disposed of at the
end of its service life.
Please contact Lantheus
Medical Imaging for proper
disposal.
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TROUBLESHOOTING
Observed Issue
Likely Cause
Corrective Action Required
Display does not operate when
power switch is on.
No main power
Check power supply and power cord connection
Fuse is blown
Contact Lantheus Medical Imaging for assistance
(see page 18).
Motor does not operate after
START button is pressed.
Cover is open
Close the cover
VIALMIX®
RFID
stops during
activation cycle.
Cover has been opened or STOP
button has been pressed
during activation cycle.
Do not attempt to use the DEFINITY® vial since it
was not properly activated. Do not open the cover
during activation. Only press the STOP button
if needed.
An error occurred during the
activation cycle.
Do not use the DEFINITY® vial since it was not
properly activated. Please refer to page 9 for a list
of errors. Retain the vial and call Lantheus Medical
Imaging (see page 18).
Fuse is blown
Do not use the DEFINITY® vial since it was not
properly activated. Retain the vial and call
Lantheus Medical Imaging (see page 18).
MAINTENANCE
All internal components in VIALMIX®RFID are maintenance-free. Therefore, maintenance of any internal components of
the unit is not required. 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.
CLEANING
All external surfaces
of VIALMIX®RFID should be cleaned with a soft cloth and, if necessary, with 70% Isopropyl
Alcohol, 3% Ammonia, or 1:500 dilution Sodium Hypochlorite
.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.
U nder no
circumstances should any solvents or abrasive detergents be used since these can damage the plastic.
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VIALMIX®RFID CALIBRATION AND REPLACEMENT PROCEDURES
No calibration is required for VIALMIX®RFID.Once powered on, VIALMIX®RFID will display the following when ready for
use:
If VIALMIX®RFID is not functioning properly, contact Lantheus Medical Imaging (see page 18) to determine if a
replacement unit is required.
ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY (EMC)
VIALMIX®RFID has been tested for electrical safety and Electromagnetic Compatibility and found to be in compliance with
the following standards:
IEC 60601-1 – General Safety
IEC 60601-1-2 – Electromagnetic Compatibility
FCC Part 15B – Unintentional Radiator
FCC Part 15C – Intentional Radiator
The following is a summary of EMC testing:
Emissions Executive Test Summary
Test Type
Test Level
Compliance Level
Conducted Emissions
EN55011:2009 + A1:2010, IEC/CISPR 11:2009
+A1:2010, and EN55032:2012
Group 1, Class A
150 kHz to 30 MHz
Group 1, Class A
150 kHz to 30 MHz
Radiated Emissions
EN55011:2009 + A1:2010, IEC/CISPR 11:2009
+A1:2010,and EN55032:2012
Group 1, Class A
30 MHz to 1 GHz
Group 1, Class A
30 MHz to 1 GHz
Harmonics
IEC/EN 61000-3-2:2006/A2:2014
Class A Device Per Clause 5 of the Standard
Flicker
IEC/EN 61000-3-3:2013 Per Clause 5 of the Standard Per Clause 5 of the Standard
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Immunity Executive Test Summary
Test Type
Test Level
Compliance Level
Electrostatic Discharge
IEC/EN 61000-4-2
±2, 4, 6 & 8kV contact discharge
±2, 4, 8 & 15kV
air discharge
±2, 4, 6 & 8kV contact discharge
±2, 4, 8 & 15kV
air discharge
Radiated Immunity
IEC/EN 61000-4-3
.
80 MHz - 6 GHz
3 V/m
80% @ 1 kHz
Spot frequencies 385MHz – 5.750 GHz Pulse
Modulation
80 MHz - 6 GHz
3 V/m
80% @ 1 kHz
Spot frequencies 385MHz – 5.750 GHz
Pulse Modulation
Proximity field from RF wireless
communications equipment
IEC 61000-4-3
See Section 6.17.3.1
Or Table 9 of standard
See Section 6.17.3.1
Or Table 9 of standard
Conducted Immunity
(AC Power)
(I/O Lines)
IEC/EN 61000-4-6
0.15 - 80 MHz
3 Vrms & 6Vrms in ISM Band 1 kHz
AC Mains
0.15 - 80 MHz
3 Vrms & 6Vrms in ISM Band 1 kHz
AC Mains
Electrical Fast Transients
(AC Power)
IEC/EN 61000-4-4
±2 kV AC Mains
±1 kV I/O Lines
5/50
5kHz &100 kHz
±2 kV AC Mains
±1 kV I/O Lines
5/50
5kHz &100 kHz
Surge Line to Line
(AC Power)
IEC/EN 61000-4-5
±1 kV
Line to Line
±2 kV
Line to Ground
±1 kV
Line to Line
±2 kV
Line to Ground
Magnetic Immunity
IEC/EN-61000-4-8 30 A/m 30 A/m
Voltage Dips & Interruptions
IEC/EN 61000-4-11
0% T.5 cycle
0%

T1 cycle
70% T25 cycles
0% T5 Sec
0% T.5 cycle
0%

T1 cycle
70% T25 cycles
0% T5 Sec
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General Requirements Summary
Standards
Description
Severity Level or Limit
Criteria
Results
IEC 60601-1-2:2014
Clause 4.1
Risk Management Process for ME
equipment and ME System
Per Section One,
Clause 4
Verification of
Electromagnetic
Disturbance Risk
Management
Complies
IEC 60601-1-2:2014
Clause 5
ME Equipment and ME System
Identification, marking and
documents
See requirements
called out in standard.
Review Complies
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device
may not cause harmful interference, and (2) this device must accept any interference received, including interference
that may cause undesired operation.
EMC CLASSIFICATION
VIALMIX®RFID is classified as Class A equipment as defined by FCC, CISPR-11, and 60601-1-2. VIALMIX®RFIDis intended
for professional use only in a hospital or clinical setting.
Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part
15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the
equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency
energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio
communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case
the user will be required to correct the interference at his own expense.
Changes or modifications not expressly approved by Lantheus Medical Imaging could void the user’s authority to
operate the equipment.
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Specifications
Drive: Ball-bearing brushless DC motor
Control System:
Microprocessor-controlled, high-precision shaking time
and frequency
Vial Carrier: Self-retaining
Construction: Aluminum base and die cast zinc shaker
frame; casing
and cover made of high impact-resistant plastic
Shaking Frequency: 4530 oscillations per minute
Shaking Duration: 45-seconds
Recommended Operating
Temperature/Humidity: 15 to 30° C / 20 to 95% Non-Condensing Relative Humidity
Storage
Temperature/Humidity: -20 to 55° C / 10 to 95% Non-Condensing Relative Humidity
LineVoltage: 100-240 V, 2 A, 50-60 Hz
Voltage (V)/Amp (A)/Hertz (Hz) ratings are listed
on the type plate on the back of theVIALMIX®RFID
Power Input: 330VA
Dimensions: Height: 165 mm
Depth: 195 mm
Width: 195 mm
Weight: 3759 g
Fuses: Time-lag fuses with amperage rating as listed on
the type plate on the back of the VIALMIX®RFID
RFID Transceiver
Frequency: 13.56 MHz per ISO 15693
Effective Radiated Power: 1.1mW
Modulation: Amplitude Shift Keying (ASK/OOK),
100% Modulation Depth
FCC ID: 2ASDC-VMIX2
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CONTACT LANTHEUS MEDICAL IMAGING
If you are experiencing issues with VIALMIX®RFID, please call Lantheus Medical Imaging at:
(U.S.) 1-800-362-2668
For customer orders or for requesting a printed copy of the Instructions for Use, please call
Lantheus Medical Imaging Customer Services at:
(U.S.) 1-800-299-3431
Distributed in USA by:
Lantheus Medical Imaging, Inc.
331 Treble Cove Rd.
North Billerica, Massachusetts 01862 USA
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