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VIALMIX.
/ 1 10
Activation
Device for
DEFINITY®
Vial for
(Perflutren
Lipid
Microsphere)
Injectable
Suspension
User's Guide/
Instructions for Use
\~
Lantheus
'W'
Medical
Imaging·
516041-1118
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Table of Contents
Related Manuals for Lantheus Medical Imaging VIALMIX RFID
Summary of Contents for Lantheus Medical Imaging VIALMIX RFID
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Page 2: Table Of Contents
Table of Contents Safety Precautions Meaning of Safety Symbols System Overview Setup Operation Usage Counter Error Messages Troubleshooting Maintenance Cleaning VIALMIX® Calibration and Replacement Procedures RFID Electrical Safety and Electromagnetic Compatibility (EMC) Specifications Contact Information Page | 2 516041-1118... -
Page 3: Safety Precautions
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®... -
Page 4: Meaning Of Safety Symbols
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®... -
Page 5: System Overview
SYSTEM FEATURES OVERVIEW VIALMIX® is the activation unit designed specifically for DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable RFID 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®... -
Page 6: Setup
SET-UP VIALMIX® is packaged with a power cord and a Quick Reference Guide. Upon receipt of VIALMIX® and prior to RFID RFID use with DEFINITY®, the user must perform the following steps. 1. Remove VIALMIX® and its power cord from the package. RFID 2. - Page 7 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.
- Page 8 DEFINITY® is ready for use if VIALMIX® shakes the vial uninterrupted for the full activation cycle with no error RFID 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.
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Page 9: Usage Counter
(see page 11) when > 95% of the programmed RFID limit of activation cycles has been reached. Please contact Lantheus Medical Imaging Customer Service IMMEDIATELY upon receiving this alert to request a new VIALMIX® . Once the usage counter reaches 100% of the programmed RFID limit of activation cycles, a Usage Count Error message will be displayed on the VIALMIX®... - Page 10 (MC) loading or motor activated. Retain the vial and failure. Audible alert 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. Do not use the DEFINITY®...
- Page 11 2. RFID Tag is Do not use the DEFINITY® unreadable. vial. Retain the vial and call 3. No DEFINITY® Lantheus Medical Imaging vial in the (see page 18). cradle. Close the cover and press the Cover Open (before...
- Page 12 Error Associated VIALMIX® Response Likely Cause of Action Required by User RFID Message Contact Customer Service Usage Count Alert Usage Count Alert message on main screen VIALMIX® RFID immediately for a (>95%) exceeded 95% but VIALMIX® replacement RFID less than 100% of (see page 18).
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Page 13: Troubleshooting
Therefore, maintenance of any internal components of RFID 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. -
Page 14: Vialmix® Rfid Calibration And Replacement Procedures
. Once powered on, VIALMIX® will display the following when ready for RFID RFID use: If VIALMIX® is not functioning properly, contact Lantheus Medical Imaging (see page 18) to determine if a RFID replacement unit is required. ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY (EMC) VIALMIX®... - Page 15 Immunity Executive Test Summary Test Type Test Level Compliance Level ± 2, 4, 6 & 8kV contact discharge ± 2, 4, 6 & 8kV contact discharge Electrostatic Discharge ± 2, 4, 8 & 15kV ± 2, 4, 8 & 15kV IEC/EN 61000-4-2 air discharge air discharge...
- Page 16 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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Page 17: Specifications
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... -
Page 18: Contact Information
CONTACT LANTHEUS MEDICAL IMAGING If you are experiencing issues with VIALMIX® , please call Lantheus Medical Imaging at: RFID (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... - Page 19 Page | 19 516041-1118...
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