Lantheus Medical Imaging VIALMIX RFID, User'S Manual/Instructions For Use

Page 1: ...0 0 VIALMIX 110 Activation Device for DEFINITY Vial for Perflutren Lipid Microsphere Injectable Suspension User s Guide Instructions for Use Lantheus W Medical Imaging 516041 1118...

Page 2: ...iew 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 Co...

Page 3: ...rved 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...

Page 4: ...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 M...

Page 5: ...sure 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 butt...

Page 6: ...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...

Page 7: ...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...

Page 8: ...cle 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 DEFI...

Page 9: ...hat 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 a...

Page 10: ...l 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...

Page 11: ...t 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...

Page 12: ...8 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 prog...

Page 13: ...etain 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 1...

Page 14: ...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 Tes...

Page 15: ...r 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...

Page 16: ...uipment as defined by FCC CISPR 11 and 60601 1 2 VIALMIX RFID is intended for professional use only in a hospital or clinical setting Note This equipment has been tested and found to comply with the l...

Page 17: ...5 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 t...

Page 18: ...ging 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...

Page 19: ...Page 19 516041 1118...