Table of Contents Safety Precautions 3 Meaning of Safety Symbols 4 System Overview 5 Setup 6 Operation 6 Usage Counter 8 Error Messages 9 Troubleshooting 12 Maintenance 12 Cleaning 12 VIALMIX®RFID Calibration and Replacement Procedures 13 Electrical Safety and Electromagnetic Compatibility (EMC) 13 Specifications 14 Contact Information 15 Page | 2 516041-1118
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.
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 Page | 4 516041-1118
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.
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. 2. 3. 4. 5. Remove VIALMIX®RFID and its power cord from the package. Remove all packing materials from the unit. Place VIALMIX®RFID on a flat surface. Open the cover and remove the shipping restraint from the arm. Connect VIALMIX®RFID to the main power source using the enclosed power cord.
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).
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.
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 Motor Overvoltage Associated VIALMIX®RFID Response Motor Overvoltage error message on main screen (MO) Audible alert Likely Cause of Message Action Required by User Motor is operating higher than standard voltage condition indicating potential future failure. Do not use the DEFINITY® vial. Vial was not acceptably activated. Retain the vial and call Lantheus Medical Imaging (see page 15). Power cycle the unit using the power switch on the back of the unit to clear the error.
Error Interrupted Cycle – STOP button pushed Interrupted Cycle – Cover opened Associated VIALMIX®RFID Response Interrupted Cycle error message on main screen (IC) Audible alert Interrupted Cycle error message on main screen (IC) with cover open icon Audible alert Likely Cause of Message Action Required by User User pushed STOP button midcycle, creates partially activated vial. Do not use the DEFINITY® vial. Vial was not acceptably activated.
TROUBLESHOOTING Observed Issue Display does not operate when power switch is on. Motor does not operate after START button is pressed. VIALMIX®RFID stops during activation cycle. Likely Cause Corrective Action Required No main power Check power supply and power cord connection Fuse is blown Contact Lantheus Medical Imaging for assistance (see page 15). Cover is open Close the cover Cover has been opened or STOP button has been pressed during activation cycle.
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 15) to determine if a replacement unit is required.
Specifications Page | 14 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 rotations per minute Shaking Duration: 45-second cycle Recommended Operating Temperature/Humidity: 15 to 30° C / 20 to 55% Non-Condensing Relative Humidity Storage Temperature/Hum
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.
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