Lantheus Medical Imaging VIALMIX User manual

®
VI A L M I X
AC T I VAT I O N D E V I C E F O R D E F I N I T Y®
V I A L F O R (P E R F L U T R E N L I P I D M I C RO S P H E R E )
I N J E C TA B L E S U S P E N S I O N
U S E R ’SG U I D E
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Technical Service Reference:
If you need technical assistance or have questions aboutVialmix®,
call Lantheus Medical Imaging Technical Services at
1-800-362-2668.
Customer Service Reference:
For customer orders, please call Lantheus Medical Imaging Customer
Services at 1-800-299-3431.
Caution: The only intended use ofVialmix®is for the activation of
Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension.
CAUTION: US Federal law restricts this device to sale by or on the order
of a licensed medical practitioner.
Distributed in USA by:
Lantheus Medical Imaging
331 Treble Cove Road
North Billerica, Massachusetts 01862 USA
Distributed in Canada by:
Lantheus MI Canada, Inc
Montréal, Canada
Distributed in México by:
Ralca S. A. de C.V.
Edo. de México
Distributed in Korea by:
Boo Kyung S.M. Co., Ltd.
Seoul, Korea
Distributed in Singapore by:
QT Instruments Pte. Ltd.
Distributed in Australia by:
Lantheus Medical Imaging Australia Pty. Ltd.
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1 Q U I C K -S TA R TI N S T R U C T I O N S 1.1
2 I N T R O D U C T I O N
Safety Precautions 2.1
System Features Overview 2.2
Set-up 2.3
3 O P E R AT I O N
Powering On/Off 3.1
Loading theVial 3.2
Activating theVial 3.3
Removing theVial 3.4
4 S A F E T Y F E AT U R E S
Cover Shut-off Switch 4.1
CANCEL Button 4.2
Thermal Sensor Shut-off Switch 4.3
5 L E D A L E R TM E S S A G E S 5.1
6 T R O U B L E S H O O T I N G 6.1
7 C L E A N I N G 7.1
8 M A I N T E N A N C E 8.1
9 S P E C I F I C AT I O N S 9.1
T E C H N I C A L S E R V I C E 10.1
C O N T E N T S
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S E T-U P
■Re m ove packaging, including red transport collar from base of vial carri e r.
■PlaceVialmix®on a flat surface and verify voltage compatibility.
■Connect Vialmix®to the main power source using enclosed power
cord. Non-grounded plug adaptors should never be used.
■Power on Vialmix®by moving switch to “1.”
■LED display briefly shows “88,” then “45.”
O P E R AT I O N
I N S E RT I N G V I A L A N D A C T I V AT I N G D E F I N I T Y ®V I A L F O R
(P E R F LU T R E N L I P I D M I C R O S P H E R E ) I N J E C T A B L E S U S P E N S I O N :
1Press lever downward and to the left to open the carrier.
2Hold Definity®vial between thumb and fingers and load vial
by first placing the top of the vial in the left cup of carrier;
position vial between the two cups.
3Release the lever; then close the Vialmix®cover.
4Press START and countdown from “45” to “00” will begin.
R E M O V I N G V I A L :
1When the full 45-second cycle is complete, openVialmix®cover.
2Press lever downward and to the left to open the carrier.
3Remove vial.
4Close the cover.
P O W E R I N G O F F V I A L M I X®
Vialmix®should be powered off at the end of the day by moving the switch
on the back of the unit to “0.”
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NOTE:
Vialmix
®
will
not operate with
cover open.
Do not open
cover while Vialmix
®
is operating.
Wait 7 minutes
between
activations.
If the cycleis
interrupted for any
reason, the Defin i t y
®
vial is unusable.
Retain vial
and contact
Lantheus Medical
Imaging Technical
Services.
(See pg. 10.1)
Keep cover closed
when not in use.
Q U I C K S TA RT
I N S T R U C T I O N S
1.1
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IMPORTANT:
Read this section
carefully before
plugging in and
operating the unit.
The unit must be
used in strict
accordance with
these instructions.
We have no liability
for any damage
arising from any
other use of
this unit.
S A F E T Y P R E C A U T I O N S
■Before the unit is put into operation,make sure that the operating
voltage indicated on the type plate is the same as the supply voltage
available. Incorrect voltage may damage the unit.
■This unit must only be operated with the lid closed and intact.
■During operation, the Definity®vial must be the only object placed
under the cover.
■The unit must be placed on a level surface.
■A dangerous condition can result from condensation build-up. Before
using the unit, allow the unit to reach room temperature, particularly
when moving it from a colder to a warmer environment.
■To safely operate the unit, insert the main plug only into an appropriate
outlet with a grounded conductor. If an extension cord is used, make
sure that the grounded conductor is not broken.
■Turn off and unplug the unit from the power outlet befo re changing fuses.
■Use only correct fuses.Do not use rep aired fuses or bypass the fuse holder.
■In order to avoid electrical shock,DO NOT INSERT ANY OBJECTS INTOTHE UNIT.
■If , for any re a s o n , it is possible that the safety of a unit has been
co mp rom i s e d, that unit must be re m oved from operation and identified
in such a way that it is not inadver te nt ly operated again by a third
p a rt y. For example, do not use unit if it does not work as specified or
is visibly damaged.
■Keep solve n t s, inflammable liquids and powerful heat sources aw ay from unit.
■Do not allow cleansers to get into unit during cleaning; an electrical
s h o rt or a dangerous malfunction may occur. Do not immerse unit in
any liquid.
■Except for fuse repl a ce m en t , all repairs should only be done by
Lantheus Medical Imaging approved personnel. Do not open unit housing.
I N T R O D U C T I O N
2.1
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